Description
This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of a representative population in their clinical trials. This guidance considers both demographic characteristics of study populations (e.g., sex, race, ethnicity, age, location of residency) and non-demographic characteristics of populations (e.g., patients with organ dysfunction, comorbid conditions, disabilities, those at the extremes of the weight range, and populations with diseases or conditions with low prevalence). Enrolling participants with a wide range of baseline characteristics may create a study population that more accurately reflects the patients likely to take the drug if it is approved and allow assessment of the impact of those characteristics on the safety and effectiveness of the study drug.
Scope & Applicability
Product Classes
2The drug being tested in clinical trials for MDS.
A higher degree of uncertainty is common in drug development programs for rare diseases.
Stakeholders
7Target audience for recommendations on assessment of overall survival
HHS office providing resources for the public
FDA office providing resources on women in clinical trials
Established to identify gaps in knowledge for safe therapies
Veterinarian responsible for selecting anesthetic regimens and conducting field studies
responsible for justifying omission of studies
Governs top dose in clinical studies
Regulatory Context
Attributes
3sex, race, ethnicity, age, location of residency
Evaluation of product safety and effectiveness
Specific classification used to define heart failure exclusion
Related CFR Sections (3)
- 21CFR56.111§ 56.111 Criteria for IRB approval of research.
(a) In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied:Read full regulation →
- 21CFR50.20§ 50.20 General requirements for informed consent.
Except as provided in §§ 50.22 , 50.23 , and 50.24 , no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An invesRead full regulation →
- 21CFR50.25§ 50.25 Elements of informed consent.
(a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to each subject:Read full regulation →
Related Warning Letters (10)
- 2025-12-23
In Vivo Bioavailability-Bioequivalence Studies – Clinical
Maria A. Carballosa, M.D.
- 2025-12-09
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Celularity, Inc
- 2025-11-18
Sponsor/Investigator
Verdure Sciences, Inc.
- 2025-09-30
Clinical Investigator (Sponsor)
Pamela K. Den Besten, DDS, MS
- 2025-09-23
Clinical Investigator/Sponsor
Ralph A. DeFronzo, M.D.
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-07-01
Clinical Investigator
Peter Michael, M.D.
- 2025-06-10
Clinical Investigator (Sponsor)
American Behavioral Research Institute, LLC
- 2025-06-03
Bioresearch Monitoring Program
Amy Lightner, MD
See Also (8)
- Payment and Reimbursement to Research Subjects: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials (Status: Draft)
- IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators: Draft Guidance for Sponsor-Investigators (Status: Draft)
- Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Recruiting Study Subjects: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice: Draft Guidance for Industry (Status: Draft)
- Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment : Guidance for Industry (Status: Final)
- CVM GFI #282 Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals (Status: Draft)