{"description":"Documents matching 'Clinical Trial Management requirements'","count":3765,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=Clinical+Trial+Management+requirements&format=json&page=2","results":[{"title":"Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products.\" This document provides guidance on the appropriate use of Bayesian methods in clinical trials. The primary focus is on the use of Bayesian methods to support primary inference in pivotal clinical trials designed to support the effectiveness and safety of drug and biological products.","document_number":"2026-00325","html_url":"https://www.federalregister.gov/documents/2026/01/12/2026-00325/use-of-bayesian-methodology-in-clinical-trials-of-drug-and-biological-products-draft-guidance-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-01-12/pdf/2026-00325.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-00325.pdf?1767966312","publication_date":"2026-01-12","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of Bayesian Methodology in <span class=\"match\">Clinical</span> <span class=\"match\">Trials</span> of Drug and Biological Products.” This document provides guidance on the appropriate use of Bayesian methods in <span class=\"match\">clinical</span> <span class=\"match\">trials</span>. The primary focus is on the use of Bayesian methods to support primary inference in pivotal <span class=\"match\">clinical</span> <span class=\"match\">trials</span> designed to support the effectiveness and safety of drug and biological products. \n \n \n DATES: \n Submit either electronic or written comments on the"},{"title":"E20 Adaptive Designs for Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"E20 Adaptive Designs for Clinical Trials.\" The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to provide a transparent and harmonized set of recommendations for clinical trials with an adaptive design. The draft guidance focuses on principles for the planning, conduct, analysis, and interpretation of clinical trials with an adaptive design that aim to confirm the efficacy and support the benefit-risk assessment of a treatment. The draft guidance emphasizes principles that are critical for ensuring clinical trials produce reliable and interpretable results and that involve specific considerations with use of an adaptive design.","document_number":"2025-18897","html_url":"https://www.federalregister.gov/documents/2025/09/30/2025-18897/e20-adaptive-designs-for-clinical-trials-international-council-for-harmonisation-draft-guidance-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-30/pdf/2025-18897.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18897.pdf?1759149909","publication_date":"2025-09-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"defined as a <span class=\"match\">clinical</span> <span class=\"match\">trial</span> design that allows for prospectively planned modifications to one or more aspects of the <span class=\"match\">trial</span> based on interim analysis of accumulating data from participants in the <span class=\"match\">trial</span>. Adaptive designs offer a variety of advantages and challenges. This draft guidance emphasizes principles that are critical for ensuring <span class=\"match\">clinical</span> <span class=\"match\">trials</span> produce reliable and interpretable results and that involve specific considerations with use of an adaptive design. While this draft guidance primarily focuses on confirmatory <span class=\"match\">clinical</span> <span class=\"match\">trials</span>, the principles"},{"title":"TRICARE Coverage of Clinical Trials and Termination of Expanded Access Treatments","type":"Rule","abstract":"The Assistant Secretary of Defense for Health Affairs (ASD(HA)) issues this final rule regarding circumstances under which services and supplies related to emerging treatments may be covered under the TRICARE program. This rule finalizes provisions published in two interim final rules (IFRs) with request for comment, which temporarily added coverage for the treatment use of investigational drugs under U.S. Food and Drug Administration (FDA)-authorized expanded access (EA) programs when for the treatment of coronavirus disease 2019 (COVID-19) and permitted coverage of National Institute of Allergy and Infectious Disease (NIAID)-sponsored clinical trials for the treatment or prevention of COVID-19. This final rule discusses the DoD's decision not to make permanent the coverage of treatment use of investigational drugs under FDA EA programs while updating language for care associated with their administration and broadens the COVID-19 clinical trial benefit to include coverage of clinical trials sponsored or approved by any National Institutes of Health (NIH) Center or Institute to treat or prevent infectious diseases associated with a pandemic or epidemic. Lastly, the final rule expands TRICARE's clinical trial benefit by covering services and supplies provided in conjunction with Phase I, II, III, and IV clinical trials that are NIH-sponsored or approved and that involve a new treatment or cure for a specific condition or the treatment of a currently uncontrolled symptom or aspect of that condition, provided that the condition is severely debilitating, life- threatening, or a rare disease.","document_number":"2025-14206","html_url":"https://www.federalregister.gov/documents/2025/07/28/2025-14206/tricare-coverage-of-clinical-trials-and-termination-of-expanded-access-treatments","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-28/pdf/2025-14206.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-14206.pdf?1753447522","publication_date":"2025-07-28","agencies":[{"raw_name":"DEPARTMENT OF DEFENSE","name":"Defense Department","id":103,"url":"https://www.federalregister.gov/agencies/defense-department","json_url":"https://www.federalregister.gov/api/v1/agencies/103","parent_id":null,"slug":"defense-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"Disease 2019 <span class=\"match\">Clinical</span> <span class=\"match\">Trials</span>,” which discussed temporary coverage of NIAID-sponsored <span class=\"match\">clinical</span> <span class=\"match\">trials</span> for the treatment of COVID-19, published in the \n Federal Register \n on October 30, 2020 (85 FR 68753-68758). Comments were accepted for 30 days, and the DoD received four comments. The DoD thanks all commenters for their submissions. In the COVID-19 <span class=\"match\">Clinical</span> <span class=\"match\">Trials</span> IFR, the DoD specifically solicited comments on the potential expansion of TRICARE's <span class=\"match\">clinical</span> <span class=\"match\">trial</span> benefit beyond cancer <span class=\"match\">clinical</span> <span class=\"match\">trials</span> and NIAID-sponsored COVID-19 <span class=\"match\">clinical</span> <span class=\"match\">trials</span>. Two comments"},{"title":"Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft document entitled \"Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations.\" The draft guidance document provides recommendations to sponsors who are planning clinical trials of cell and gene therapy (CGT) products intended for use in a disease or condition that affects a small population, generally one that meets the definition of a rare disease or condition under section 526(a)(2) of the FD&C Act (21 U.S.C. 360bb(a)(2)). It describes FDA requirements and provides considerations for the use of various clinical trial designs and endpoints to generate clinical evidence to support product licensure. The recommendations are intended for sponsors developing CGTs intended for use in small populations to leverage the use of innovative trial designs to simultaneously expedite drug development and generate data necessary to demonstrate substantial evidence of effectiveness.","document_number":"2025-18651","html_url":"https://www.federalregister.gov/documents/2025/09/25/2025-18651/innovative-designs-for-clinical-trials-of-cellular-and-gene-therapy-products-in-small-populations","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-25/pdf/2025-18651.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18651.pdf?1758717925","publication_date":"2025-09-25","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Designs for <span class=\"match\">Clinical</span> <span class=\"match\">Trials</span> of Cellular and Gene Therapy Products in Small Populations.” The draft guidance document provides recommendations to sponsors who are planning <span class=\"match\">clinical</span> <span class=\"match\">trials</span> of cell and gene therapy (CGT) products intended for use in a disease or condition that affects a small population, generally one that meets the definition of a rare disease or condition under section 526(a)(2) of the FD&amp;C Act (21 U.S.C. 360bb(a)(2)). It describes FDA <span class=\"match\">requirements</span> and provides considerations for the use of various \n \n <span class=\"match\">clinical</span> <span class=\"match\">trial</span> designs and"},{"title":"E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials.\" The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to provide general principles on the conduct of clinical trials that include pregnant and breastfeeding women to inform evidence-based decisions on safe and effective use of medicinal products by these populations. The draft guidance includes approaches to generating data that support informed decision-making on the safety, dosing, and efficacy of medicinal products during pregnancy and breastfeeding. Additionally, the draft guidance includes recommendations for recruiting and retaining pregnant and breastfeeding women in clinical trials, while reducing burden and harm on these participants.","document_number":"2025-13680","html_url":"https://www.federalregister.gov/documents/2025/07/21/2025-13680/e21-inclusion-of-pregnant-and-breastfeeding-women-in-clinical-trials-international-council-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-21/pdf/2025-13680.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-13680.pdf?1752842718","publication_date":"2025-07-21","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"or Agency) is announcing the availability of a draft guidance for industry entitled “E21 Inclusion of Pregnant and Breastfeeding Women in <span class=\"match\">Clinical</span> <span class=\"match\">Trials</span>.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical <span class=\"match\">Requirements</span> for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to provide general principles on the conduct of <span class=\"match\">clinical</span> <span class=\"match\">trials</span> that include pregnant and breastfeeding women to inform evidence-based decisions on safe and effective use of medicinal products by these"},{"title":"Approaches to Assessment of Overall Survival in Oncology Clinical Trials; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Approaches to Assessment of Overall Survival in Oncology Clinical Trials.\" The purpose of this draft guidance is to provide recommendations to sponsors on the assessment of overall survival in randomized oncology clinical trials conducted to support marketing approval of drugs and biological products, with an emphasis on the analysis of overall survival as a prespecified safety endpoint. While the draft guidance discusses situations in which it is appropriate to consider overall survival for the primary endpoint, this draft guidance primarily focuses on statistical or design considerations when overall survival is not the primary endpoint.","document_number":"2025-15796","html_url":"https://www.federalregister.gov/documents/2025/08/19/2025-15796/approaches-to-assessment-of-overall-survival-in-oncology-clinical-trials-draft-guidance-for-industry","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-19/pdf/2025-15796.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-15796.pdf?1755521132","publication_date":"2025-08-19","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"guidance for industry entitled “Approaches to Assessment of Overall Survival in Oncology <span class=\"match\">Clinical</span> <span class=\"match\">Trials</span>.” The purpose of this draft guidance is to provide recommendations to sponsors on the assessment of overall survival in randomized oncology <span class=\"match\">clinical</span> <span class=\"match\">trials</span> conducted to support marketing approval of drugs and biological products, with an emphasis on the analysis of overall survival as a prespecified safety endpoint. Overall survival is an objective, <span class=\"match\">clinically</span> meaningful endpoint that can be measured easily and precisely. It is considered a gold"},{"title":"E6(R3) Good Clinical Practice; International Council for Harmonisation; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"E6(R3) Good Clinical Practice.\" The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance includes a principles document and annex 1 and is the precursory guidance to the draft guidance entitled \"E6(R3) Good Clinical Practice: Annex 2.\" Once complete, the guidance will be composed of a principles document, annex 1, and annex 2. The guidance is intended to outline flexible and modern good clinical practices for conducting clinical trials. Notably, the guidance highlights the importance of quality-by-design, proportionality, and risk-based approaches in conducting clinical trials to ensure safety and reliability of results. The guidance also encourages use of innovative design elements and technology in clinical trials, while avoiding unnecessary complexities. The guidance finalizes the draft guidance of the same title issued on June 7, 2023.","document_number":"2025-17311","html_url":"https://www.federalregister.gov/documents/2025/09/09/2025-17311/e6r3-good-clinical-practice-international-council-for-harmonisation-guidance-for-industry","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-09/pdf/2025-17311.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-17311.pdf?1757335516","publication_date":"2025-09-09","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Good <span class=\"match\">Clinical</span> Practice.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical <span class=\"match\">Requirements</span> for Pharmaceuticals for Human Use (ICH). The guidance includes a principles document and annex 1 and is the precursory guidance to the draft guidance entitled “E6(R3) Good <span class=\"match\">Clinical</span> Practice: Annex 2.” Once complete, the guidance will be composed of a principles document, annex 1, and annex 2. The guidance is intended to outline flexible and modern good <span class=\"match\">clinical</span> practices for conducting <span class=\"match\">clinical</span> <span class=\"match\">trials</span>. Notably"},{"title":"M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP).\" The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance includes three documents: a guidance, a template, and a technical specification document. The guidance provides the rationale and recommendations for implementing a harmonized digital clinical trial protocol. The template features standardized content structure and formatting, including headers and common text elements. The technical specification document contains harmonized terminologies and standardized data fields to enable electronic exchange of clinical protocol information. The intent of the guidance is to create an internationally harmonized standard for the content and exchange of clinical trial protocol information, facilitating the review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders. This guidance finalizes the draft guidances \"M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP)\" issued on December 22, 2022 (87 FR 78696), and \"M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol\" issued on June 6, 2025 (90 FR 24146).","document_number":"2026-10295","html_url":"https://www.federalregister.gov/documents/2026/05/22/2026-10295/m11-clinical-electronic-structured-harmonised-protocol-cesharp-international-council-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-22/pdf/2026-10295.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10295.pdf?1779367514","publication_date":"2026-05-22","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"electronic exchange of <span class=\"match\">clinical</span> protocol information. The intent of the guidance is to create an internationally harmonized standard for the content and exchange of <span class=\"match\">clinical</span> <span class=\"match\">trial</span> protocol information, facilitating the review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders. This guidance finalizes the draft guidances “M11 <span class=\"match\">Clinical</span> Electronic Structured Harmonised Protocol (CeSHarP)” issued on December 22, 2022 (87 FR 78696), and “M11 Technical Specification: <span class=\"match\">Clinical</span> Electronic Structured Harmonised"},{"title":"Core Patient-Reported Outcomes in Cancer Clinical Trials; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Core Patient-Reported Outcomes in Cancer Clinical Trials.\" This final guidance provides recommendations to sponsors regarding the collection of a core set of patient-reported clinical outcomes (herein referred to as core patient-reported outcomes) in cancer clinical trials and related considerations for instrument selection and trial design. This final guidance focuses on patient-reported outcome (PRO) measures and is specific to registration trials for anti-cancer therapies intended to demonstrate an effect on survival, tumor response, or delay in the progression of a malignancy.","document_number":"2024-24111","html_url":"https://www.federalregister.gov/documents/2024/10/18/2024-24111/core-patient-reported-outcomes-in-cancer-clinical-trials-guidance-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-18/pdf/2024-24111.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-24111.pdf?1729169138","publication_date":"2024-10-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"final guidance for industry entitled “Core Patient-Reported Outcomes in Cancer <span class=\"match\">Clinical</span> <span class=\"match\">Trials</span>.” This final guidance provides recommendations to sponsors regarding the collection of a core set of PROs in cancer <span class=\"match\">clinical</span> <span class=\"match\">trials</span> and related considerations for instrument selection and <span class=\"match\">trial</span> design. The final guidance recommendations supplement previous guidance on use of PRO measures in <span class=\"match\">clinical</span> <span class=\"match\">trials</span> by providing additional considerations specific to the cancer <span class=\"match\">clinical</span> <span class=\"match\">trial</span> setting. The final guidance is intended to facilitate generation of high-quality"},{"title":"Considerations for Including Tissue Biopsies in Clinical Trials; Draft Guidance for Industry, Investigators, Institutions, and Institutional Review Boards; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) and the Office for Human Research Protections (OHRP) are announcing the availability of a draft guidance for industry, clinical investigators, institutions, and institutional review boards (IRBs) entitled \"Considerations for Including Tissue Biopsies in Clinical Trials.\" This guidance provides recommendations regarding considerations for tissue biopsies that may be conducted in adults and in children as part of clinical trials evaluating investigational medical products and/or that are conducted or supported by the Department of Health and Human Services (HHS).","document_number":"2024-31536","html_url":"https://www.federalregister.gov/documents/2025/01/07/2024-31536/considerations-for-including-tissue-biopsies-in-clinical-trials-draft-guidance-for-industry","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31536.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31536.pdf?1736171121","publication_date":"2025-01-07","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"industry, <span class=\"match\">clinical</span> investigators, institutions, and IRBs entitled “Considerations for Including Tissue Biopsies in <span class=\"match\">Clinical</span> <span class=\"match\">Trials</span>.” This guidance is intended to assist industry, <span class=\"match\">clinical</span> investigators, institutions, and IRBs in understanding considerations for tissue biopsies that may be conducted in adults and in children as part of <span class=\"match\">clinical</span> <span class=\"match\">trials</span> that evaluate investigational medical products and/or that are conducted or supported by HHS. For the purposes of this guidance, a biopsy is a procedure that involves acquisition of tissue from a <span class=\"match\">trial</span> participant"},{"title":"Conducting Clinical Trials With Decentralized Elements; Guidance for Industry, Investigators, and Other Interested Parties Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry, investigators, and other interested parties entitled \"Conducting Clinical Trials With Decentralized Elements.\" This guidance provides recommendations regarding the implementation of decentralized elements in clinical trials for drugs, biological products, and devices. Decentralized elements allow trial-related activities to occur remotely at locations convenient for trial participants (e.g., telehealth visits with investigators or visits with local healthcare providers (HCPs)). FDA's regulatory requirements are the same for trials that include decentralized elements and trials that do not include decentralized elements. To help ensure the appropriate oversight trials with decentralized elements, the integrity of trial data, and the safety of trial participants, this guidance covers the responsibilities of sponsors and investigators. This guidance finalizes the draft guidance entitled \"Decentralized Clinical Trials for Drugs, Biological Products, and Devices\" issued on May 3, 2023.","document_number":"2024-21078","html_url":"https://www.federalregister.gov/documents/2024/09/18/2024-21078/conducting-clinical-trials-with-decentralized-elements-guidance-for-industry-investigators-and-other","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-18/pdf/2024-21078.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-21078.pdf?1726577115","publication_date":"2024-09-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Remote Data Acquisition in <span class=\"match\">Clinical</span> Investigations” (December 2023). \n \n In this guidance, a decentralized <span class=\"match\">clinical</span> <span class=\"match\">trial</span> (DCT) refers to a <span class=\"match\">clinical</span> <span class=\"match\">trial</span> that includes decentralized elements where <span class=\"match\">trial</span>-related activities occur at locations other than traditional <span class=\"match\">clinical</span> <span class=\"match\">trial</span> sites. These <span class=\"match\">trial</span>-related activities may take place at the location of <span class=\"match\">trial</span> participants (\n e.g., \n their homes) or in local healthcare facilities that are close to <span class=\"match\">trial</span> participants' locations. FDA's regulatory <span class=\"match\">requirements</span> are the same for <span class=\"match\">trials</span> that include decentralized"},{"title":"Psychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled \"Psychedelic Drugs: Considerations for Clinical Investigations.\" Because interest in the therapeutic potential of psychedelic drugs has been increasing and designing clinical trials to evaluate these compounds presents unique challenges, FDA developed the draft guidance to present foundational aspects for sponsors to consider. This final guidance provides general considerations for sponsors developing psychedelic drugs for the treatment of medical conditions (e.g., psychiatric disorders, substance use disorders) and discusses recommendations for clinical investigations psychedelic drugs. This guidance finalizes the draft guidance of the same title issued on June 26, 2023.","document_number":"2026-14158","html_url":"https://www.federalregister.gov/documents/2026/07/14/2026-14158/psychedelic-drugs-considerations-for-clinical-investigations-guidance-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-14/pdf/2026-14158.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-14158.pdf?1783946717","publication_date":"2026-07-14","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Considerations for <span class=\"match\">Clinical</span> Investigations.” Because interest in the therapeutic potential of psychedelic drugs has been increasing and designing <span class=\"match\">clinical</span> <span class=\"match\">trials</span> to evaluate these compounds presents unique challenges, FDA developed the draft guidance to present foundational aspects for sponsors to consider. This final guidance provides general considerations for sponsors developing psychedelic drugs for the treatment of medical conditions (\n e.g., \n psychiatric disorders, substance use disorders) and discusses recommendations for <span class=\"match\">clinical</span> investigations"},{"title":"Clinical Trials Registration and Results Information Submission","type":"Rule","abstract":"The Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), is amending its regulation governing clinical trials registration and results information submission to update throughout the regulation the internet web address or uniform resource locator (URL) of the site that provides information about formatting of information for submission, procedures, and tools as specified in the regulation.","document_number":"2024-28475","html_url":"https://www.federalregister.gov/documents/2024/12/09/2024-28475/clinical-trials-registration-and-results-information-submission","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-09/pdf/2024-28475.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-28475.pdf?1733492716","publication_date":"2024-12-09","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"excerpts":"its regulation governing <span class=\"match\">clinical</span> <span class=\"match\">trials</span> registration and results information submission to update throughout the regulation the internet web address or uniform resource locator (URL) of the site that provides information about formatting of information for submission, procedures, and tools as specified in the regulation. \n \n \n DATES: \n This final rule is effective December 9, 2024. \n \n \n FOR FURTHER INFORMATION CONTACT: \n \n Daniel Hernandez, NIH Regulations Officer, Office of <span class=\"match\">Management</span> Assessment, Division of <span class=\"match\">Management</span> Support, 6011 Executive"},{"title":"Proposed Collection: 30-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI)","type":"Notice","abstract":"In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.","document_number":"2026-05937","html_url":"https://www.federalregister.gov/documents/2026/03/27/2026-05937/proposed-collection-30-day-comment-request-the-clinical-trials-reporting-program-ctrp-database-nci","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-27/pdf/2026-05937.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-05937.pdf?1774529107","publication_date":"2026-03-27","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"National Institutes of Health","name":"National Institutes of Health","id":353,"url":"https://www.federalregister.gov/agencies/national-institutes-of-health","json_url":"https://www.federalregister.gov/api/v1/agencies/353","parent_id":221,"slug":"national-institutes-of-health"}],"excerpts":"Office of <span class=\"match\">Management</span> and Budget (OMB) a request for review and approval of the information collection listed below. \n \n Proposed Collection Title: \n The <span class=\"match\">Clinical</span> <span class=\"match\">Trials</span> Reporting Program (CTRP) Database, 0925-0600, Expiration Date 02/28/2026-REINSTATEMENT WITH CHANGE, National Cancer Institute (NCI), National Institutes of Health (NIH).\n \n \n Need and Use of Information Collection: \n The <span class=\"match\">Clinical</span> <span class=\"match\">Trials</span> Reporting Program (CTRP) is an electronic resource that serves as a single, definitive source of information about all NCI-supported <span class=\"match\">clinical</span> research"},{"title":"Proposed Collection: 30-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI)","type":"Notice","abstract":"In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.","document_number":"2026-03709","html_url":"https://www.federalregister.gov/documents/2026/02/25/2026-03709/proposed-collection-30-day-comment-request-the-clinical-trials-reporting-program-ctrp-database-nci","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-25/pdf/2026-03709.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-03709.pdf?1771940708","publication_date":"2026-02-25","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"National Institutes of Health","name":"National Institutes of Health","id":353,"url":"https://www.federalregister.gov/agencies/national-institutes-of-health","json_url":"https://www.federalregister.gov/api/v1/agencies/353","parent_id":221,"slug":"national-institutes-of-health"}],"excerpts":"to the Office of <span class=\"match\">Management</span> and Budget (OMB) a request for review and approval of the information collection listed below. \n \n Proposed Collection Title: \n The <span class=\"match\">Clinical</span> <span class=\"match\">Trials</span> Reporting Program (CTRP) Database, 0925-0600, Expiration Date 02/28/2026-REVISION, National Cancer Institute (NCI), National Institutes of Health (NIH).\n \n \n Need and Use of Information Collection: \n The <span class=\"match\">Clinical</span> <span class=\"match\">Trials</span> Reporting Program (CTRP) is an electronic resource that serves as a single, definitive source of information about all NCI-supported <span class=\"match\">clinical</span> research. This"},{"title":"Proposed Collection; 60-Day Comment Request; the Clinical Trials Reporting Program (CTRP) Database (NCI)","type":"Notice","abstract":"In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.","document_number":"2025-23713","html_url":"https://www.federalregister.gov/documents/2025/12/23/2025-23713/proposed-collection-60-day-comment-request-the-clinical-trials-reporting-program-ctrp-database-nci","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-23/pdf/2025-23713.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23713.pdf?1766411118","publication_date":"2025-12-23","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"National Institutes of Health","name":"National Institutes of Health","id":353,"url":"https://www.federalregister.gov/agencies/national-institutes-of-health","json_url":"https://www.federalregister.gov/api/v1/agencies/353","parent_id":221,"slug":"national-institutes-of-health"}],"excerpts":"The <span class=\"match\">Clinical</span> <span class=\"match\">Trials</span> Reporting Program (CTRP) Database, 0925-0600, Expiration Date 02/28/2026-REVISION, National Cancer Institute (NCI), National Institutes of Health (NIH).\n \n \n Need and Use of Information Collection: \n The <span class=\"match\">Clinical</span> <span class=\"match\">Trials</span> Reporting Program (CTRP) Database is an electronic resource that serves as a single, definitive source of information about all NCI-supported <span class=\"match\">clinical</span> research. This resource allows the NCI to consolidate reporting, aggregate information and reduce redundant submissions. Information is submitted by <span class=\"match\">clinical</span> research"},{"title":"E6(R3) Good Clinical Practice: Annex 2; International Council for Harmonisation; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"E6(R3) Good Clinical Practice: Annex 2.\" The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is the second annex to \"E6(R3) Good Clinical Practice\" published June of 2023. This annex provides additional considerations for the application of good clinical practices to a variety of trial designs and data sources. Specifically, this draft guidance discusses trials with decentralized and pragmatic elements and real-world data sources. This draft guidance highlights the importance of quality by design and focusing efforts and resources on critical aspects of the trials that might impact the safety of participants and the reliability of results. The draft guidance is intended to encourage innovation in trial design and provides flexible, modern, and clear good clinical practices for conducting trials, while avoiding unnecessary complexities.","document_number":"2024-31275","html_url":"https://www.federalregister.gov/documents/2024/12/30/2024-31275/e6r3-good-clinical-practice-annex-2-international-council-for-harmonisation-draft-guidance-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-30/pdf/2024-31275.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31275.pdf?1735307162","publication_date":"2024-12-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"industry entitled “E6(R3) Good <span class=\"match\">Clinical</span> Practice: Annex 2.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical <span class=\"match\">Requirements</span> for Pharmaceuticals for Human Use (ICH). The draft guidance is the second annex to “E6(R3) Good <span class=\"match\">Clinical</span> Practice” published June of 2023. This annex provides additional considerations for the application of good <span class=\"match\">clinical</span> practices to a variety of <span class=\"match\">trial</span> designs and data sources. \n \n Specifically, this draft guidance discusses <span class=\"match\">trials</span> with decentralized and pragmatic"},{"title":"Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice.\" FDA is publishing this draft guidance as part of a series of guidance documents under its Real-World Evidence (RWE) Program and to satisfy, in part, a mandate under the Federal Food, Drug, and Cosmetic Act to issue guidance about the use of RWE in regulatory decision-making. This draft guidance is intended to support the conduct of randomized controlled drug trials with streamlined protocols and procedures that can integrate research into routine clinical practice.","document_number":"2024-21077","html_url":"https://www.federalregister.gov/documents/2024/09/18/2024-21077/integrating-randomized-controlled-trials-for-drug-and-biological-products-into-routine-clinical","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-18/pdf/2024-21077.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-21077.pdf?1726577115","publication_date":"2024-09-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Controlled <span class=\"match\">Trials</span> for Drug and Biological Products Into Routine <span class=\"match\">Clinical</span> Practice.” This draft guidance is intended to support the conduct of randomized controlled drug <span class=\"match\">trials</span> with streamlined protocols and procedures that focus on essential data, allowing integration of research into routine <span class=\"match\">clinical</span> practice. Depending on the condition and the intervention to be studied, the spectrum of <span class=\"match\">trial</span> designs may range from those that are almost completely reliant on data acquired by the participant's local healthcare providers during routine <span class=\"match\">clinical</span> practice"},{"title":"Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects.\" This draft guidance makes recommendations on followup testing for Ames-positive active ingredients in circumstances when a sponsor decides to continue development. The guidance recommends a consistent process of followup testing and evaluation that first should be conducted for an Ames-positive active ingredient before proceeding with first-in-human (FIH) trials in healthy human subjects. These recommendations are intended to potentially help address and lower safety concerns before proceeding with FIH trials in healthy human subjects.","document_number":"2024-27796","html_url":"https://www.federalregister.gov/documents/2024/11/27/2024-27796/recommended-followup-testing-for-an-ames-positive-drug-active-ingredient-or-metabolite-to-support","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-27/pdf/2024-27796.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-27796.pdf?1732628729","publication_date":"2024-11-27","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Support First-in-Human <span class=\"match\">Clinical</span> <span class=\"match\">Trials</span> With Healthy Subjects.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the <span class=\"match\">requirements</span> of the applicable statutes and regulations. \n II. Paperwork Reduction Act of 1995 \n While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of <span class=\"match\">Management</span> and Budget (OMB) under"},{"title":"Proposed Collection; 60-Day Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank (National Library of Medicine)","type":"Notice","abstract":"In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.","document_number":"2025-21244","html_url":"https://www.federalregister.gov/documents/2025/11/26/2025-21244/proposed-collection-60-day-comment-request-information-program-on-clinical-trials-maintaining-a","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-26/pdf/2025-21244.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-21244.pdf?1764078336","publication_date":"2025-11-26","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"National Institutes of Health","name":"National Institutes of Health","id":353,"url":"https://www.federalregister.gov/agencies/national-institutes-of-health","json_url":"https://www.federalregister.gov/api/v1/agencies/353","parent_id":221,"slug":"national-institutes-of-health"}],"excerpts":"of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and by the <span class=\"match\">Clinical</span> <span class=\"match\">Trials</span> Registration and Results Information Submission regulations at 42 CFR part 11. ClinicalTrials.gov collects registration and results information for <span class=\"match\">clinical</span> <span class=\"match\">trials</span> and other types of <span class=\"match\">clinical</span> studies (\n e.g., \n observational studies and patient registries) with the objectives of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of <span class=\"match\">clinical</span> studies to the benefit of public health. It is widely used by patients, physicians"}]}