Diversity Plans  to Improve  
Enrollment of Participants  
from  Underrepresented  Racial 
and Ethnic  Populations  in  
Clinical Trials  
Guidance for  Industry  
DRAFT GUIDANCE  
This guidance  document is being distributed for  comment  purposes  only.  
Comments and suggestions regarding this draft document should be submitted within 60  days of  
publication in the  Federal Register  of the notice announcing the availability of the draft  
guidance.   Submit electronic comments to  https://www.regulations.gov.  Submit written comments  
to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers  
Lane, Rm. 1061, Rockville, MD   20852.  All comments should be identified with the docket  
number  listed in the notice of availability that publishes in the  Federal Register.  
For  questions regarding this draft document, contact (OCE/CDER) Lola Fashoyin-Aje, 240-402-
0205, (CBER) Office of Communication, Outreach, and Development,  800-835-4709, or  240-
402-8010, or  CDRHClinicalEvidence@fda.hhs.gov. 
U.S.Department  of Health and Human Services  
Food and Drug Administration  
Oncology Center of Excellence (OCE)  
Center for Drug Evaluation and  Research (CDER)  
Center for Biologics Evaluation and Research (CBER)  
Center for Devices and Radiological Health (CDRH)  
Office of Minority Health and Health Equity (OMHHE) 
April 2022 
Clinical/Medical   Diversity Plans  to Improve  
Enrollment of Participants  
from  Underrepresented  Racial 
and Ethnic  Populations  in  
Clinical Trials  
Guidance for  Industry  
Additional copies are available from:  
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Center for Drug Evaluation and Research   Center for Biologics Evaluation  and  Research  
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guidances  
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http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm  
U.S.Department  of Health and Human Services  
Food and Drug Administration  
Oncology Center of Excellence (OCE)  
Center for Drug Evaluation and  Research (CDER)  
Center for Biologics Evaluation and Research (CBER)  
Center for Devices and Radiological  Health (CDRH) 
Office of Minority Health and Health Equity (OMHHE) 
April 2022  
Clinical/ Medical  Contains  Nonbinding Recommendations  
Draft   Not for Implementation  
TABLE OF CONTENTS  
 
 
I.    INTRODUCTION ...................................................................................................... 1  
II.    BACKGROUND ........................................................................................................ 3  
III.   WHEN A RACE AND ETHNICITY DIVERSITY PLAN IS  RECOMMENDED ....  5  
IV.    TIMELINES  AND PROCESS  FOR SUBMITTING  RACE AND ETHNICITY 
DIVERSITY PLANS ............................................................................................................. 5  
V.    CONTENT OF THE RACE AND ETHNICITY DIVERSITY PLAN  ......................  6  
  Contains Nonbinding Recommendations  
Draft   Not for Implementation  
1  Diversity Plans to Improve Enrollment of  Participants  from 
2  Underrepresented  Racial and Ethnic  Populations  in  Clinical Trials  
3  Guidance for  Industry1  
4   
5   
6  This  draft guidance, when finalized, will represent the current thinking of the Food and Drug 
7  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not  
8  binding on FDA or the public.   You can use an alternative approach if it satisfies the requirements of the 
9  applicable statutes  and regulations.   To discuss an alternative approach, contact the FDA staff responsible  
10  for this guidance as  listed on the title page.    
11   
12   
13   
14  I.    INTRODUCTION  
15   
16  The purpose of this guidance is to provide  recommendations  to sponsors developing medical  
17  products2 on the approach for developing a Race and Ethnicity Diversity Plan (henceforth 
18  referred to as the Plan) to enroll representative numbers of participants from underrepresented  
19  racial and ethnic populations in the United States, such as Black  or African American, 
20  Hispanic/Latino, Indigenous and Native American, Asian,  Native Hawaiian and Other  Pacific 
21  Islanders, and other persons of color, in clinical trials.3   Individuals from these populations are 
22  frequently underrepresented in biomedical research despite having a disproportionate disease  
23  burden for certain diseases relative to their proportional  representation in the general population.   
24  Adequate representation  of these populations  in clinical trials  and studies supporting regulatory 
25  submissions helps ensure  that the data generated in the development program reflect the racial  
26  and ethnic diversity of  the  population expected to use the medical  product  if approved,  and  may  
 
1  This guidance has  been prepared by the Oncology  Center of Excellence (OCE) in collaboration with  the Center for 
Drug Evaluation and Research (CDER), the  Center for Biologics Evaluation and Research (CBER), the Center for 
Devices and  Radiological Health (CDRH), and the Office of Minority Health and Health Equity  (OMHHE) at the  
Food and Drug Administration.  
2  For  the purposes  of this guidance, medical product is used to refer to human drugs  (including  human biological 
products that are regulated as  drugs) and medical devices. 
3  FDA  follows the Office of Management a nd Budgets definitions of ra ce and ethnicity.   See Office of Management 
and Budget (OMB) Directive No. 15 Revisions  to the Standards for the Classification of Federal Data on Race and  
Ethnicity (October 30, 1997), available at  https://www.whitehouse.gov/wp-content/uploads/2017/11/Revisions-to-
the-Standards-for-the-Classification-of-Federal-Data-on-Race-and-Ethnicity-October30-1997.pdf.  Consistent with  
OMB Policy Directive 15, the categories in this classification are social-political constructs and should  not be  
interpreted as being scientific or anthropological in nature.   Ethnicity is comprised of two categories: 
Hispanic/Latino or not Hispanic/Latino. Race is comprised of five minimum categories:   American Indian  or Alaska 
Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White.   In certain  
situations, as recommended in OMB Policy Directive 15, more detailed race and ethnicity information may be 
desired. OMB sta ndards do not designate underrepresented populations, thus FDAs recommendations rega rding  
race and ethnicity data in clinical tria ls provide additional guidance, see the  guidance for industry  Collection of Race 
and Ethnicity Data in Clinical Trials  (October 2016).   We update guidances  periodically. For the most recent 
version of a guidance, check the FDA guidance  web page at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents.  
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Draft   Not for Implementation  
27  potentially identify  effects on  safety or efficacy outcomes  that may be associated with, or occur  
28  more frequently within  these  populations.  
29   
30  As discussed below, this guidance focuses specifically on racial  and ethnic  demographic 
31  characteristics  of study  populations,  recognizing the  broader issues regarding health disparities  
32  and differential access to health care  in  certain  racial and ethnic  populations, many  of whom  are 
33  part of underserved communities.  However,  FDA advises  sponsors to seek diversity in clinical 
34  trial enrollment beyond  populations defined by  race and ethnicity, including  other  
35  underrepresented  populations  defined by demographics such as sex, gender identity4,  age,  
36  socioeconomic  status,  disability, pregnancy status, lactation status,  and co-morbidity.  FDA 
37  encourages  sponsors  to  also submit plans  that help ensure the  adequate participation of relevant  
38  and underrepresented populations and analyses of  data collected from clinically relevant 
39  subpopulations.5   
40   
41  This  guidance  expands on FDAs guidance, Collection of Race and Ethnicity Data in Clinical 
42  Trials  (October 2016),  which outlines how to collect and present race and ethnicity data in 
43  submissions to the FDA and recommends  that sponsors  develop  and submit  a  plan to address  
44  inclusion of clinically relevant populations,  for discussion to the Agency.   Given the importance  
45  of increasing enrollment from  historically  underrepresented racial and ethnic populations, FDA  
46  is  publishing this guidance to provide detail on what sponsors should include in a Race and 
47  Ethnicity Diversity Plan.   As  described  in further detail below,  FDA  recommends  that a  Plan  to  
48  enroll  representative numbers of  participants  from  historically  underrepresented racial and ethnic 
49  populations  be submitted to the  investigational new drug (IND) application, for a drug, including  
50  biological products  regulated as drugs, or the investigational device exemption (IDE)  
51  application, for a device.  This Plan should  be discussed  with the FDA  as soon as practicable 
52  during  medical product  development.  For drugs, this should occur  no later than when a sponsor is  
53  seeking feedback regarding the applicable pivotal trial(s) for the drug (often during the  End of  
54  Phase 2  (EOP2) meeting).   The current  guidance  provides general considerations for the content  
55  and format of the  Plan.   This guidance is not intended to address all issues related to the clinical 
56  development of  medical products  such as the design of studies, trial endpoints, or the data  
57  package necessary to support a marketing application;  sponsors should refer to the appropriate  
58  FDA guidance  documents for FDA recommendations  on these matters.   
59   
60  The contents of this document do not have the force and effect of law and are not meant to bind 
61  the public in any way, unless specifically incorporated into a contract.   This document is  
 
4  See  National Strategy on  Gender Equity and Equality. https://www.whitehouse.gov/wp-
content/uploads/2021/10/National-Strategy-on-Gender-Equity-and-Equality.pdf.   
5  Adequate participation and  analyses of  data  collected from clinically relevant subpopulations may provide  
important information pertaining to medical product  safety and effectiveness for product labeling.   Additional 
patient characteristics such as age, sex, gender, geographic location (e.g., rural), emotional, physical, sensory, and 
cognitive capabilities can often be important  variables when evaluating medical product safety and efficacy.   While  
these additional characteristics  are not addressed in this guidance, FDA encourages sponsors to consider broadening 
their diversity plans to include all clinically relevant populations as appropriate.   FDA guidance on  Enhancing the  
Diversity of Clinical Trial Populations: Eligibility Criteria, Enrollment Practices, and Trial  Designs  encourages the 
inclusion of persons with disabilities in  clinical trials  including during the study design phase.   For example, FDA 
guidance recommends that sponsors consider the recruitment  challenges that may occur because  of the planned visit  
schedule and difficulties with accessibility. FDA also has guidance on inclusion of older adults in clinical trials.  
  2   Contains Nonbinding Recommendations  
Draft   Not for Implementation  
62  intended  only to provide clarity to the public regarding existing requirements under the law.  
63  FDA  guidance documents, including this guidance, should be viewed only as recommendations,  
64  unless specific regulatory or statutory requirements are cited.   The use of the word should  in  
65  FDA  guidance means that something is suggested or recommended, but not required.   
66   
67   
68  II.    BACKGROUND  
69   
70  Clinical trials  are used to characterize the safety  and  effectiveness  of medical products  intended 
71  for the  prevention,  treatment,  or diagnosis of many diseases, including those that are serious and 
72  life-threatening.   Across  many  therapeutic areas,  participation in clinical trials  may be an  
73  important component of  a participants clinical  care.    
74   
75  FDA  regulations require IND holders to  include in their annual reports,  among other things,  the  
76  total number of subjects  initially planned for inclusion in a clinical study  and  the number entered  
77  into the study to date,  tabulated  by age  group, race, and  gender.6   In addition, a new drug  
78  application  (NDA)  must present effectiveness and safety data by gender, age, and  race  and must  
79  identify any modifications of dose or dose interval needed for  a specific subgroup.7  
80   
81  Medical product  development programs  should consider  the clinical and  demographic factors  
82  that impact  the  generalizability  of study results  with respect to the patient population that will 
83  use the medical product  once it is approved.   Diverse  populations  as defined by race and 
84  ethnicity  are  relevant to the evaluation of  medical products  and there have been some observed 
85  correlations between  self-reported race,  ancestry,  genetic variations  or ethnicity, and response.8    
86   
87  FDA has issued  several sets of  recommendations to improve clinical trial diversity.9,10   These 
88  recommendations address  a range of  topics,  including: the collection and analysis of racial and  
89  ethnic  data; measures that enhance diversity in clinical trials; and the broadening of eligibility  
90  criteria when scientifically appropriate to improve clinical trial participation.   Stakeholders have  
91  also recommended that sponsors develop a plan that outlines the operational measures that will  
92  be implemented to ensure diverse clinical trial participation to  improve the generation of  
93  evidence regarding safety and effectiveness across the entire population.11   Such measures could  
94  include but are not limited to  offering financial reimbursement for expenses incurred  by 
 
6  See  21 CFR 312.33(a)(2).  
7  See  21 CFR 314.50(d)(5)(v  and vi).  
8  Burchard EG et al., The Importance of Race and  Ethnic Background in Biomedical Research and Clinical Practice. 
N Engl J Med  2003; 348(12):1170-1175. 
9  See  FDASIA  Section 907: Inclusion of Demographic Subgroups in Clinical Trials  available at 
https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/fdasia-
section-907-inclusion-demographic-subgroups-clinical-trials.   See also FDA Action Plan to Enhance the Collection  
and Availability of  Demographic Subgroup Data available at https://www.fda.gov/media/89307/download.  
10  See  the following three  guidances  for industry:   Enhancing the Diversity of Clinical Trial Populations    
Eligibility Criteria, Enrollment Practices, and Trial Designs (November 2020); Collection of Race and Ethnicity  
Data in Clinical Trials  (October 2016); and  Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in  
Medical Device Clinical Studies  (September 2017).  
11  See Cancer Disparities Progress Report 2020: Achieving the  bold vision of health equity for racial and ethnic 
minorities and other underserved populations. American Association for Cancer Research; 2020.Available  at 
https://cancerprogressreport.aacr.org/disparities/.  
  3   Contains Nonbinding Recommendations  
Draft   Not for Implementation  
95  participation in a clinical trial or study (e.g., travel or lodging)12, providing language access to 
96  participants with limited English language proficiency,  and  partnering with community-based  
97  organizations to provide support to study or trial  participants.   FDA  guidance  documents define a 
98  diverse population, when applicable,  to be inclusive of  all  populations  as defined by  
99  demographic factors such as  race, ethnicity,  sex,  gender identity,  age,  pregnancy  status,  lactation 
100  status13,  and by the presence of certain  clinical characteristics such as  multiple comorbidities.   
101  Some individuals  from  these groups have often been underrepresented in  medical product  
102  development and FDA considers their  representation  in clinical trials  and studies to be a priority.   
103  FDA  has, for some of these populations, already  published  specific guidance  (e.g.,  enrollment of  
104  women,  including pregnant and lactating women,  and older adults).14,15   However, FDA is 
105  focusing this guidance on diversity plans to improve enrollment of participants from  
106  underrepresented  racial and ethnic populations  because the  lack of  representation  of these 
107  populations in clinical research reflects, in part, a broader issue regarding differential access to  
108  health care16, including access to centers that conduct clinical research programs for new  
109  therapies  and awareness of clinical trials conducted there.   In addition, mistrust of the clinical 
110  research system may stem from historical events that adversely impacted racial and ethnic  
111  minorities, such as the unethical Tuskegee experiments.17   Clinical trials  designed to include  
112  pediatric participants  should also  take into account adequate representation of children from  
113  racial and ethnic minority  backgrounds.18    
114   
115  Swift development and approval of medical products is a highly desirable goal for the public, 
116  sponsors,  and the  FDA.   There has been increasing reliance on relatively small studies,  
117  intermediate endpoints, and innovative  study  designs to expedite development and approval of  
 
12  FDA  does not consider reimbursement for reasonable travel expenses to and from  the clinical trial site and 
associated costs such as airfare, parking, and lodging to raise issues regarding undue influence.   Similarly,  
consideration may be given to paying participants in exchange for their participation in research.   FDA recognizes, 
however, that payment for participation may raise difficult questions that should be addressed by the Institutional 
Review Board (IRB), such as how much  money participants should  receive, and for what participants should receive  
payment, such as their time, inconvenience, discomfort, or some other consideration.   See Information Sheet 
Payment and  Reimbursement to Research Subjects (January 2018)  https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/payment-and-reimbursement-research-subjects  
13  See the draft guidance for industry Pregnant Women: Scientific  and Ethical  Considerations for Inclusion in  
Clinical Trials  (April 2018)).   When final, this guidance will represent the FDAs current thinking on this topic.  See  
also  the guidance for industry  Evaluation of  Sex-Specific Data in Medical Device  Clinical Studies  (August 2014).    
14  See the guidance for industry  Guideline for the Study and Evaluation of Gender Differences in the Clinical 
Evaluation of Drugs (July 1993). See  the following two draft guidances for industry:  Pregnant Women: Scientific  
and Ethical Considerations for Inclusion in Clinical Trials (April 2018) and Clinical Lactation Studies:  
Considerations for Study Design Guidance for Industry  (May 2019).   When final, these guidances will represent the  
FDAs  current thinking on these topics. 
15  See the following guidances for industry:   Guideline for the Study of Drugs Likely to be Used in the Elderly  
(November 1989) and  E7  Studies in Support of Special Populations: Geriatrics Questions and Answers  (February  
2012). 
16 Cooper Lisa A., Health Inequity and Racism Affect Patients and Health Care Workers Alike Vol. 2  No. 3  March 
2021 NEJM Catalyst Innovations in Care Delivery, 2021; 03. doi:10.1056/CAT.21.0033. 
17  Shariff et al., More than Tuskegee: Understanding Mistrust about Research Participation J Health  Care Poor 
Underserved. 2010 August; 21(3):  879897. doi:10.1353/hpu.0.0323. 
18  For  further considerations regarding the inclusion of pediatric participants in clinical investigations, see the 
guidances for industry  E11 Clinical  Investigation of Medicinal  Products in the Pediatric Population (December  
2000) and Pediatric Study Plans: Content of and Process for Submitting Initial  Pediatric Study Plans and  Amended  
Initial Pediatric Study Plans  (July 2020).  
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118  medical products, notably for rare diseases and for serious and life-threatening conditions.   
119  Specific approaches are needed to both obtain data in diverse populations and facilitate efficient 
120  medical product  development and approval.   This underscores the  importance of  prospectively  
121  defining the approach to generating data for a broader and more diverse population early in the  
122  development program.   Consistent implementation of actions to improve racial and ethnic  
123  diversity in clinical trials  and studies can support  early access to medical discoveries and  
124  innovations,  improve  the  generalizability of results  across all  patient populations, improve our  
125  understanding of the disease and/or medical product under study, and inform the safe and 
126  effective use of the medical product for all patients who are expected to use the medical product  
127  if approved.  
128   
129   
130  III.   WHEN A  RACE AND ETHNICITY DIVERSITY PLAN IS  RECOMMENDED  
131   
132  FDA recommends a Plan be submitted for medical products for which an IND submission is 
133  required and/or for which clinical studies are intended to support a marketing submission under  
134  section  351(a) of the  Public Health Service Act for a standalone Biologics License Application  
135  (BLA),  or under  505(b)(1)  or 505(b)(2)19  of the Federal Food, Drug, and Cosmetic Act (the  
136  FD&C Act) for an NDA.   A Plan is also recommended for medical products for which an IDE is  
137  required and/or  for which clinical studies are intended to support a device marketing submission,  
138  whether a premarket notification (510(k))20, premarket approval (PMA) application21, a De Novo  
139  classification request22, or a humanitarian device exemption (HDE) application.23   FDA will 
140  evaluate the Race and Ethnicity Diversity Plan as an important part of the sponsors development  
141  program.  
142   
143   
144  IV.    TIMELINES  AND PROCESS  FOR SUBMITTING  RACE AND ETHNICITY 
145  DIVERSITY PLANS  
146   
147  Sponsors may discuss their strategy to enroll a diverse study population at any time throughout  
148  the medical products development.24   
149  A.  For  drugs, sponsors should submit  the  Plan  to the relevant IND application  as soon as 
150  practicable during drug development but no later than when a sponsor is seeking  
151  feedback regarding the applicable pivotal trial(s) for the drug (often at the EOP2 
152  meeting).   The Plan can be submitted to the IND as part of  a milestone meeting  package,  
 
19  To the extent that the submission will include clinical studies that are sponsored by the applicant.   
20  See 21 CFR 807  
21  See 21 CFR 814.20  
22  See section 513(f)(2) of the FD&C Act  
23  See 21 CFR 814.104  
24  The plan should emphasize the enrollment of participants from underrepresented racial and ethnic populations 
early and throughout medical product development  to ensure  the availability  of sufficient data about the safety and 
effectiveness of the product  in diverse populations.  In the event  that recruitment goals  are not met  despite best  
efforts, sponsors should  discuss with FDA a plan to collect  this data in the post-marketing setting.  
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153  or on its  own.  Sponsors  should  request FDA feedback on the Plan by including specific  
154  questions in a  formal milestone meeting request and  Meeting Package.25   
155  B.   For  devices, sponsors should submit their Plan as part of the investigational plan included  
156  in the IDE application.   To discuss a proposed enrollment strategy before submitting  the  
157  Plan to the IDE  or for clinical studies not conducted under an IDE, a sponsor should 
158  follow the Q-submission process for obtaining feedback or requesting a meeting with 
159  FDA.  
160  C.   For IND, IDE, or Q  submissions containing a Plan, sponsors should alert the FDA by 
161  marking the submission with RACE AND ETHNICITY  DIVERSITY PLAN in  
162  large,  bolded type in the cover letter. FDA may request that sponsors provide  periodic  
163  updates to specific components of  the  Plan throughout medical product  development.    
164  D.  Sponsors should include the Plan in  the  marketing  application  for the medical product as  
165  well  as a description of the successes and challenges in implementing  it.  
166   
167   
168  V.    CONTENT OF  THE  RACE AND ETHNICITY  DIVERSITY PLAN   
169    (THE PLAN)  
170   
171     Sponsors should define enrollment  goals  for  underrepresented  racial and ethnic 
172  participants  as early as practicable in clinical development for a given indication.   These 
173  enrollment goals  should be based in part on the pre-specified protocol objectives of the  
174  investigation.   While in many cases race- and/or  ethnicity- defined  populations  may be  
175  genetically heterogenous such that  analyses to characterize  differential effects due to  
176  pharmacogenomic variability  may be difficult to discern, the  Plan should begin with an 
177  assessment of any  data that may indicate the potential for  a medical product  to have  
178  differential safety or effectiveness  associated with  race  or ethnicity.  For drug  
179  development,  as applicable to the particular drug,  the collection of sufficient 
180  pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenomic data  from  a 
181  diverse population  is strongly encouraged to inform analyses  of drug exposure  and 
182  response.26   For devices, data on the relevant factors for device performance (e.g., 
183  phenotypic, anatomical, or biological) should be collected to inform any differential 
184  effects  across a diverse population.   For example,  variations in  skin pigmentation  exist 
185  across diverse populations and it is known that skin pigmentation can  affect the 
186  performance of certain devices.  For studies of such devices  (e.g.,  pulse oximeters), skin 
187  pigmentation data  in a diverse population would be a relevant attribute to collect  to  
188  inform  the assessment of  any differential effects.   
 
25  See draft guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants  of PDUFA  
Products  (December 2017).   When final, this guidance will  represent the FDAs current  thinking on this topic.  
26  See  guidance  for industry Exposure-Response Relationships    Study Design, Data Analysis, and Regulatory  
Applications  (May  2003) and  draft guidance for industry  Population Pharmacokinetics  (July 2019).   When final,  
this guidance will  represent the FDAs current thinking on this topic.   
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189     The  Plan  should describe the planned assessment of race and ethnicity in addition to other  
190  covariates with known potential to affect the safety and effectiveness of the medical  
191  product.   In particular, for drugs, covariates  with  known  potential to  affect  PK and PD  
192  should be assessed in order to facilitate exposure-response analyses and to inform safe  
193  and effective dosing regimens across  the intended patient population, as applicable.   For  
194  devices, device performance may be impacted by factors associated with race (e.g., the 
195  ability of a device to detect skin cancer based on skin pigmentation).    
196     When there are  data that indicate that the medical product may perform differentially  
197  across the population based on factors associated with race or ethnicity, the Plan should 
198  specify the study design features that will support analyses that will inform the safety and  
199  effectiveness of the medical product in the relevant racial and ethnic populations.   In  
200  some cases, increased (i.e.,  greater than proportional) enrollment of certain populations  
201  may be needed to elucidate potential important differences.   When there are no  data  that 
202  indicate  that race or ethnicity will impact  safety or effectiveness,  it is nonetheless  
203  appropriate that enrollment reflects the epidemiology of the disease.   FDA recognizes  
204  that enrollment based on epidemiology alone may not be sufficient  to detect any  
205  differences in safety and effectiveness or make such  inferences; however, consistent 
206  representative enrollment may provide opportunities for pooling data to evaluate  
207  outcomes by race and ethnicity.   
208     The Plan should outline the sponsors plan to collect data to explore the potential for  
209  differences in safety and/or effectiveness associated with race and ethnicity  throughout  
210  the entire development life-cycle of the medical product and not just during the pivotal  
211  trial(s)  or studies.  
212     In certain situations, it may be challenging to set an enrollment goal  based on the  
213  epidemiology of the disease due to limited data to characterize  the incidence and/or  
214  prevalence of  the disease across diverse racial/ethnic populations (e.g.,  diseases that  are 
215  defined by the presence of a rare molecular aberration).   FDA encourages sponsors to 
216  leverage various data sources (e.g., published literature  and real-world data) to set 
217  enrollment goals; if this is not feasible, it may be appropriate to set the enrollment goal  
218  based on  demographics in the  overall population  with the disease or condition.  
219     The Plan should include  the  clinical pediatric studies  that are planned for inclusion as part  
220  of the  pediatric development of the medical product.  
221     The table below outlines the recommended elements of  the  Plan.   Note that the examples  
222  provided in the table are intended to illustrate the type of information that should  be 
223  included in the Plan  and are not meant to be an exhaustive list of  the  measures that may  
224  be undertaken to improve diversity in clinical trials or studies.   
225   
Category   Recommended Scope  
1.   Overview of the   A.   Describe available data on the pathophysiology of  
disease/condition    the disease or condition in underrepresented racial  
and ethnic populations.  As appropriate,  describe 
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Draft   Not for Implementation  
Category   Recommended Scope  
any  differential application  or  use  of  currently 
available prevention, screening  or diagnostic  
strategies and treatments,  across racial  and ethnic  
populations.  
B.   Discuss the current understanding of and available 
evidence supporting any similarities and/or  
differences  in  the disease  or condition  under study  
that are associated with  the  underrepresented  racial  
and ethnic populations in the United  States.  
2.   Scope of  medical   Briefly describe the planned trials or  studies that will 
product   support the  medical products  safety,  effectiveness  and, if a  
drug,  dosage in a future marketing  submission.   Outline the  
development  
following:  
program  
A.   Study design, study population (including study  
eligibility  criteria), endpoints and, the expected  
geographic locations  of the  trials or  studies  and how  
these aspects of the trial or study may specifically  
address inclusion of  underrepresented racial and  
ethnic  populations.  
B.   As applicable,  summarize  any differential  findings  
from  clinical pharmacology studies (PK /PD data,  
pharmacogenomics)  that may be associated with  
certain racial and ethnic populations  and/or other  
relevant  information.  
3.   Goals for   Define and provide justification for the planned enrollment  
enrollment of   of  participants from  underrepresented  racial and ethnic  
populations.  
underrepresented  
A.   Specify  underrepresented racial and ethnic 
racial and ethnic 
populations based on assessment in Category  #1.   
participants   
B.   Specify  goals for  enrollment of  underrepresented  
racial and ethnic participants (e.g., based on the 
epidemiology of the disease and/or based on a priori  
information that may impact outcomes across  racial  
and ethnic groups;  and where appropriate, leverage 
pooled data sources or use demographic data in 
general population).   In some cases, increased (i.e.,  
greater than proportional) enrollment of certain 
populations may be needed to elucidate potential  
important differences.   
  8   Contains Nonbinding Recommendations  
Draft   Not for Implementation  
Category   Recommended Scope  
4.   Specific plan of   A.   Describe in detail the operational measures that will be  
action to enroll   implemented to enroll and retain underrepresented racial  
and ethnic participants in the planned trial(s)  or studies, 
and retain  
and the planned use of data to characterize safety,  
diverse 
efficacy, and  optimal  dosage in these participants, when 
participants  
applicable.  
 
B.   Describe specific trial enrollment  and retention 
strategies, including but not limited to:  
i.   site location and access (e.g., language  assistance for  
persons with limited English proficiency,  reasonable 
modifications for persons with disabilities, and other  
issues such as  transportation);  
ii.   sustained community engagement (e.g., community  
advisory boards and navigators,  community health 
workers, patient advocacy groups, local healthcare 
providers, etc.);  
iii.   reducing burdens due to trial/study  design/conduct  
(e.g., number/frequency of study-related procedures,  
use of local laboratory/imaging, telehealth);  
C.   Describe metrics to ensure that diverse participant  
enrollment  goals  are achieved  and specify actions to be  
implemented during the conduct of the trial(s) or studies  
if planned enrollment  goals  are not met.   
5.   Status of   A.  As  the diversity plan is  updated (when applicable),  
meeting   discuss the status of meeting enrollment goals. If  the  
sponsor is not able to achieve  enrollment goals  despite  
enrollment goals  
best efforts,  discuss  a  plan and justification  for 
(as applicable)  
collecting data in the post-marketing setting.  
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