www.fda.gov Guidance documents explain FDA’s current thinking on a topic. Guidance Snapshots are a communication tool and are not 

a substitute for the guidance document. To learn more about enhancing the diversity of clinical trials, read the guidance. 

Enhancing the Diversity of Clinical Trial Populations — 

Eligibility Criteria, Enrollment Practices, and Trial Designs

Final Guidance

This guidance recommends approaches that 

clinical trial sponsors can use to include the 

following people in the trials of drugs and 

biologics (examples: vaccines, gene therapy): 

• People who differ by their populationrelated (demographic) characteristics, 

such as sex, race, ethnicity, or age.

• People who differ by their nondemographic 

characteristics, such as having problems 

with internal organs (such as kidney or liver), 

other existing diseases (comorbidities), 

disabilities; those at the extremes of weight 

range; and populations with rare or less 

widespread diseases or conditions.

Clinical trials (or trials) test potential treatments in 

human volunteers to see whether they should be 

approved for wider use in the general population. 

Participants of a clinical trial should be similar to 

the population that will ultimately use the drug or 

biologic, if approved by FDA. This guidance offers 

recommendations for enhancing the diversity of 

clinical trial participants to ensure the drug or 

biologic product’s safety and effectiveness in a 

wide range of populations.

Why is this 

guidance important 

for patients? 

What is recommended 

in the guidance?

Guidance Snapshot for Patients

The FDA is committed to promoting practices 

that improve enrollment of populations 

underrepresented in trials. Despite these efforts, 

certain groups continue to be underrepresented. 

This guidance offers sponsors* of clinical 

trials detailed recommendations for increasing 

enrollment of underrepresented populations, 

including those with rare diseases.

*Sponsor means a person who takes responsibility 

for and initiates a clinical investigation. The 

sponsor may be an individual or pharmaceutical 

company, governmental agency, academic 

institution, private organization, or other 

organization, etc.

Why did FDA issue 

this guidance?

The guidance provides 

recommendations for 

the following:

 Broadening the eligibility criteria for 

participating in trials and avoiding 

unnecessary exclusions

 Designing trials to be accessible to 

more people

 Improving the recruitment of participants 

in trials while maintaining the safety and 

effectiveness standards

 Applying the recommendations to trials 

of drugs and biologics for rare diseases 

or conditions
www.fda.gov Guidance documents explain FDA’s current thinking on a topic. Guidance Snapshots are a communication tool and are not 

a substitute for the guidance document. To learn more about enhancing the diversity of clinical trials, read the guidance. 

Racial and ethnic minorities:

Sponsors should include racial and ethnic 

minorities in trials to identify how different 

subgroups of the population respond to the new 

drug or biologic.

Children and adolescents:

When appropriate, sponsors should include 

children and adolescents in confirmatory clinical 

trials involving adults. Sponsors should consider 

a broader pediatric development program early 

in drug development. The sponsor’s plan to 

enroll pediatric patients should be based on a 

clear scientific rationale.

Females:

Sponsors should include females in clinical trials 

in adequate numbers to allow for analysis by sex. 

In clinical trials for most drugs and biologics, 

including representatives of both sexes in 

adequate numbers allows for the detection 

of clinically significant sex-related differences 

in response.

Pregnant participants:

When possible, sponsors should consider 

including pharmacokinetic sampling to establish 

dosing in women who become pregnant during a 

trial. The information gathered from such testing 

allows sponsors to ensure safe and continued 

participation of pregnant individuals, taking into 

consideration the individuals’ risks and 

anticipated benefits. 

Examples of FDA’s 

Recommendations for 

Enrolling Diverse Populations

Representation 

of diverse 

populations in 

clinical trials

Broadening 

eligibility criteria, 

designing accessible 

trials, and improving 

trial recruitment 

and retention

Eligibility criteria are the requirements a 

participant must meet to enter a clinical trial. The 

criteria are determined for each study and may 

include such characteristics as age, sex, gender, 

medical history, current health status, and absence 

of diseases. One objective of eligibility criteria is 

to exclude people for whom the risk of an adverse 

event (a medical problem associated with a drug 

or biologic product) outweighs both the individual’s 

potential benefit from participating in the trial and 

the importance of the knowledge expected to be 

gained from the trial. 

What are eligibility criteria?
www.fda.gov Guidance documents explain FDA’s current thinking on a topic. Guidance Snapshots are a communication tool and are not 

a substitute for the guidance document. To learn more about enhancing the diversity of clinical trials, read the guidance. 

How can sponsors make clinical trial enrollment and 

retention practices more inclusive?

Educate participants about clinical trial participation.

Engage medical societies, focus groups, community advisory boards, and disease registries in 

order to more effectively meet the needs of potential participants.

• Hold recruitment events frequently and offer them during evenings and weekends. 

Sponsors can hold events in nonclinical but trusted locations, such as places of worship 

or community centers; social places of business, such as barbershops and beauty salons; 

and public gatherings, such as cultural festivals, carnivals, and parades.

• Provide cultural competency and proficiency training to clinical investigators and research 

staff so that they can build trusting relationships with participants.

Remain engaged with participants and their communities after the clinical trial ends; 

share clinical trial updates to maintain and strengthen relationships with communities.

EDUCATE

ENGAGE

RECRUIT

BE 

CULTURALLY

SENSITIVE

MAINTAIN

RELATIONSHIP

Ask for patients’ feedback; they may provide valuable insight into challenges and burdens and 

may be more willing to accept risk for a potential benefit from participation or to learn more 

about their disease.

GET 

FEEDBACK

• Use online/social media platforms to identify participants for whom traditional referral 

centers are not accessible. 

• Avoid the use of cultural generalizations and stereotypes in interactions with participants.

• Share trial resources and documents in multiple languages; use multilingual research 

staff and/or interpreters for participants with limited English comprehension.
Guidance Recap Podcast - 

Hear Highlights Straight from FDA Staff

Speaker: Atasi Poddar, PhD, Health Science Policy Analyst, Office of Medical Policy

Click here to listen Click here to read transcript

www.fda.gov Guidance Snapshots are a communication tool and are not a substitute for the guidance document.

To learn more about enhancing the diversity of clinical trials, read the guidance.

 Consider flexibilities in visit times and

reduce the frequency of in-person 

study visits, if possible.

 Enlist mobile medical professionals, 

such as nurses and blood collection 

workers (phlebotomists), to visit 

participants at home instead of 

requiring participants to visit distant 

clinical trial sites.

 Replace visits to clinical trial sites 

with electronic communication tools 

and devices, such as telephones, 

mobile phones, secured email, social 

media platforms, or digital health 

technologies if feasible.

 Inform participants of possible 

reimbursements for travel, lodging, 

and costs associated with participation 

in trials.

 Early in the drug or biologic 

development process, engage with 

patient advocacy groups, experts in the 

rare disease, and patients with the rare 

disease; ask for their suggestions on 

the design of trials, including 

trial procedures.

 After early-phase studies, when 

medically appropriate and scientifically 

sound, include participants from 

earlier-phase clinical trials in the 

longer-term studies to ensure that 

participants have access to the drug or 

biologic if they tolerate it. For example, 

consider including those who received 

placebo (any treatment that has no 

active treatment properties, such as a 

sugar pill, used for comparison) in the 

earlier trials to receive the study drug 

or biologic in the longer-term study.

How can sponsors 

make clinical trials 

less burdensome 

for participants?

How can sponsors 

make clinical trials 

for rare diseases 

more diverse?