Enhancing diversity in clinical trial populations: An agency-industry perspective

Feature ArticlesFeature Articles | 31 December 2022 | Citation

Achieving health equity – the opportunity for all patients to live a healthy life, irrespective of their circumstances – requires the collective effort of the entire medical product development ecosystem. An example of such a collaboration took place at the September 2022 RAPS Convergence in Phoenix, Arizona, with joint presentations by representatives from the US Food and Drug Administration (FDA), Health Canada, and industry (Pfizer) who discussed enhancing diversity in clinical trial populations. The topics covered diversity, its importance in clinical trials, relevant regulatory policies, initiatives to encourage recruitment of diverse populations, and a practical tool (diversity plan template) for submission to regulators. This article, written by the presenters, includes a summary of the content presented at the meeting. The forum included initial discussion and gathering of perspectives through an interactive panel and a Q&A segment with a broad regulatory audience, providing clarity of regulatory expectations and greater insight to areas of synergies and potential opportunities.
Keywords – clinical trial, diversity plan, equity, diversity
Historically, many clinical trials have not been representative of the patients most likely to use a medical product upon its approval. There is frequent underrepresentation of people from diverse groups defined by factors such as race, ethnicity, sex, gender identity, age, socioeconomic status, disability, pregnancy status, lactation status, and comorbidity. The lack of diversity in trial participation has created gaps in the understanding of treatment safety and effectiveness across the different populations. These knowledge gaps ultimately impede the quality of healthcare decision-making and the development of more effective and safer treatments or interventions.1
Achieving clinical trial diversity will require a multistakeholder approach across the healthcare ecosystem. Key efforts to enhance clinical trial diversity by FDA, Health Canada, and Pfizer are outlined in this article. The authors will assert that:
  • Patients enrolled in a clinical trial should represent the patient population that will ultimately use a medical product, if approved;
  • A diverse clinical trial population can contribute to a more generalizable assessment of a drug’s safety and efficacy;
  • If certain populations have a higher risk and/or prevalence for certain diseases, it is important that those subgroups are adequately represented in clinical trials;
  • Obstacles to diverse participation in clinical trials, such as language barriers, accessibility to clinical trial sites, and frequency of site visits, should be removed where possible; and
  • Strategies for enrolling a diverse clinical trial population should be prioritized and developed early in the drug development process, including clinical trial site selection, and reviewed throughout the duration of the trials.
 FDA regulatory perspective
The FDA recognizes that certain populations have been underrepresented in clinical trials, often without strong scientific justification. As such, the agency has a long-standing commitment to promote diversity and inclusion of underrepresented populations in clinical trials. Meaningful, diverse representation in clinical trials for FDA-regulated medical products is fundamental to the agency’s regulatory mission and is in the best interest of public health.
A diverse clinical trial population can contribute to a more accurate assessment of a drug’s safety and efficacy. In addition, certain demographic population characteristics, such as sex, age, race, and ethnicity, can have an impact on how a person responds to a therapeutic product. Similarly, demographic characteristics such as socioeconomic status and residential patterns (rural vs. urban), as well as certain populations with nondemographic characteristics, such as disease comorbidities and disabilities, should also be adequately represented in clinical trials where appropriate (Figure 1).

Source: Adapted from 2022 RAPS Convergence presentation; Fienkeng

Differences in pharmacokinetics and response to medical products (e.g., efficacy and/or safety) have been observed in racially and ethnically distinct subgroups of the US population and can influence regulatory thinking and actions. This was exemplified in the drug development program for the combined isosorbide dinitrate and hydralazine hydrochloride tablet,2 an adjunct therapy for the treatment of heart failure in self-identified Black patients. In two trials with self-identified Black and White participants, there was a notable difference in efficacy of the drug between the overall population and Black patients. In a confirmatory trial, the drug was studied in self-identified Black patients only, and consequently approved for self-identified Black patients.
Another example of observed differences in response to medical products among distinct groups is from postapproval findings with carbamazepine,3 an anticonvulsant used primarily for treating epilepsy and neuropathic pain. There were post-approval findings of rare, but serious, dermatological adverse reactions, specifically, Stevens-Johnson syndrome and toxic epidermal necrolysis, which correlated with the HLA-B*1502 allele. These adverse reactions were most prevalent in some Asian patients compared with patients in any other racial or ethnic group. Therefore, this drug has a boxed warning recommending screening for the presence of HLA-B*1502 allele in at-risk, Asian populations.
A third example of observed differences in response to medical products among distinct groups is the development of alosetron hydrochloride4 a medication for treating irritable bowel syndrome in women. Early discovery of low efficacy rates in men coupled with lower drug availability from pharmacokinetic studies resulted in a change in the indication for the drug, and it was approved only for use in women.
Fostering better participant diversity in clinical trials
The FDA continues to foster a regulatory environment that encourages and supports inclusion of diverse populations in clinical trials through solution-driven public workshops, issuing guidance documents, tool development, and encouraging clinical trial designs that incorporate community-based partnerships.
One example of fostering diversity in clinical trials is the agency development of Drug Trials Snapshots (DTS).5-8 These snapshots provide consumers and healthcare professionals with concise information about who participated in clinical trials that supported the FDA approval of new molecular entities and original biologics. They are part of an overall FDA effort to make demographic data more available and transparent to stakeholders. The information in the snapshots also highlights the geographic location where the trials were conducted and whether there were any differences in the benefits and side effects among demographic groups.
The DTS summary report for 2015-20196 provided demographic information (sex, race, age, and ethnicity) for 292,537 clinical trial participants (Figure 2).

For 2020, the summary highlighted 53 newly approved drugs and biologics.7 Overall, 32,000 patients participated in clinical trials that year. In the US, 75% of participants were White, 8% were Black or African American, 6% were Asian, and 11% were Hispanic or Latinx. In all, 56% of participants were women, and 30% were aged 65 years or older.
In 2021, the Center for Drug Evaluation and Research approved 50 novel therapies for a range of diseases.8 More than 38,000 patients participated in the clinical trials, and although some programs were able to enroll diverse participants, enrollment was lower for certain ethnic and racial groups in many of the trials.
Promoting diversity in clinical trial participants
In November 2020, FDA published a guidance9 on enhancing the diversity of clinical trial populations, focusing on eligibility criteria, enrollment practices, and clinical trial designs. The guidance discusses recommendations on broadening eligibility criteria; designing accessible clinical trials; improving recruitment methods; making clinical trial participation less burdensome; and addressing barriers to participation. The guidance also suggests applying these recommendations to clinical trials of drugs for rare diseases or conditions. Table 1 provides examples of how to address some barriers to participation.9

In addition, in January 2022, FDA published a draft guidance on digital health technologies (DHTs) for remote data acquisition in clinical investigations for the evaluation of medical products.10 This guidance outlines recommendations intended to facilitate the use of DHTs in a clinical investigation, where appropriate, which can help address some of the barriers to participation.
In April 2022, the agency published a draft guidance on diversity plans for improving enrollment of participants from underrepresented racial and ethnic populations in clinical trials to provide details on when sponsors should include a race and ethnicity diversity plan.11 The agency recommends developing a diversity plan when clinical studies are intended to support a marketing submission for drugs and biologics (section 351(a) of the Public Health Act for a standalone biologics licensing application and 505(b)(1) or 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for a new drug application) or medical devices (premarket notification (510(K)), a premarket approval application, a de novo classification request, or a humanitarian device exemption application).
FDA recommends designing a strategy to enroll a diverse population during medical product development. For drugs, this should be done as soon as practicable (but no later than when seeking advice on pivotal trials) and for medical devices, it should be done as part of the investigational plan included in the investigational device exemption. A diversity plan should also be submitted along with the marketing application and should include:
  • An overview of the relevant disease or condition;
  • Defined enrollment goals in terms of epidemiology of the disease and/or a priori information that may affect outcomes across racial and ethnic groups, and outcomes data;
  • Success and challenges in implementing the diversity plan requirements;
  • Specification of measures to enroll and retain participants (e.g., clinical trial site locations/access, community engagement, and operational burden of trials); and
  • Discussion of changes to the diversity plan if enrollment goals fall below expectations.
Finally, FDA’s Diversity in Clinical Trials Initiative, developed by the Office of Minority Health and Health Equity,12 includes public education and outreach components; addresses potential barriers to diverse groups participating and strategies to overcome barriers; combats myths relating to clinical trials; and translates trial diversity educational materials into multiple languages.
An international agency perspective: Health Canada’s SGBA Plus Action Plan
In 2021, Health Canada’s Health Products and Food Branch developed a Sex and Gender-Based Analysis Plus (SGBA Plus) Action Plan to address the barriers and challenges to equitable health product development.
The SGBA Plus is an analytical process used to assess how diverse groups of women, men, and nonbinary people may experience policies, programs, and initiatives. The “plus” acknowledges that SGBA Plus goes beyond biological (sex) and sociocultural (gender) differences and recognizes that everyone has multiple identity factors (e.g., race, ethnicity, age, geography, education, etc.) that intersect to make them who they are (Figure 3).

The analytical process of SGBA Plus is a tool that can be used to support increased diversity, equity, and inclusion (DEI) in various processes, including the development and regulation of health products. It is essential to consider SGBA Plus in health product development because biological, and sometimes social, differences between people can affect the way in which drugs function in different populations. There are many examples of the negative consequences resulting from not considering diversity factors (e.g., age, race, sex) in health product development.14,15
Moreover, there is much that is not yet known about the biological or social reasons for why different health products might function differently in certain populations. It is, therefore, essential to collect data from diverse clinical trial participants who are representative of the population that will be using the product to identify and characterize different risks between populations, even if no safety concerns have been identified.
Despite efforts to promote inclusion in clinical trials, many populations continue to be underrepresented for many complex reasons. The vision of Health Canada’s SGBA Plus Action Plan is that people in Canada (and globally) have access to information to help them make informed decisions about their treatment options based on safety and efficacy profiles of people like them.
To accomplish this, Health Canada aims to work with clinical trial sponsors, international regulators, and those who live in Canada to focus on three common goals:
  • To improve the quality of the DEI data submitted to Health Canada, which could include actions such as updating or developing new guidance document(s), requiring disaggregated data in health product submissions, and requiring SGBA Plus plans, similar to the FDA’s diversity plans, to be submitted as part of clinical trial applications;
  • To enhance the way in which DEI data are analyzed and reported by Health Canada, which could include actions such as developing internal and external training, requiring additional studies on underrepresented populations using regulatory levers, and increasing patient demographic data collection in adverse event reporting; and
  • To increase the DEI information made available to people in Canada to help build trust through transparency, which could focus on ways to increase meaningful communication of SGBA Plus information in publications that are readily accessible to patients.
The action plan deliverables over the next 2 years will focus on disaggregated data and increasing diversity in clinical trials. Health Canada is currently working on a regulatory package that will include, among other things, a requirement for clinical trial data to be submitted to Health Canada in a disaggregated fashion. New and updated guidance documents will be used to support this regulatory change, as well as provide information on increasing diversity in clinical trials.
Health Canada is interested in collaborating globally to develop diversity-related requirements that are harmonized internationally, where possible and appropriate. Finally, the agency is developing ways in which to communicate the diversity of clinical trial participants to those in Canada so that they can use that information in their decision making regarding their treatment options based on what the trial data on safety and efficacy say about people like them.
An industry perspective: Pfizer
Pfizer’s company purpose breakthroughs that change patients’ lives – guides the intentional efforts to achieve appropriate clinical trial representation. This aligns with the enterprise-wide value of equity, which the company defines as every person deserves to be seen, heard, and cared for. This expansive definition includes everything from acting with integrity to being inclusive of all identities and reducing healthcare disparities globally.16,17 As one of Pfizer’s values, equity is embedded into all internal and external work, with the ultimate goal of the company being as diverse as the patients and communities it serves.18
The quest to develop a vaccine for COVID-19 brought the issue of diversity in clinical trials into the spotlight. It highlighted the disproportionate way in which the virus affected minority communities across the US and increased the need to prioritize racial and ethnic diversity in clinical studies. To gain a further understanding of the company’s demographic baseline and how to most effectively direct outreach, Pfizer conducted an in-depth analysis of its US clinical trials17 initiated between 2011 and 2020. The analysis included 213 clinical trials studying cancer, rare diseases, vaccines, inflammatory and autoimmune diseases, and neurological conditions.19 The findings are outlined in Figure 4 and Figure 5.


The following differences in racial and ethnic participation across different Pfizer clinical trial types were identified:
  • Vaccine trials had a lower percentage of Black or African American and Hispanic or Latinx participants, and a higher percentage of Asian, White, and Non-Hispanic White participants compared with clinical pharmacology or therapeutic trials;
  • Therapeutic trials had a higher percentage of White participants compared with clinical pharmacology trials;
  • Oncology trials had an underrepresentation of Black or African American and Hispanic or Latinx populations;
  • More than 60% of clinical trials in cardiology, hematology, endocrinology, and nephrology had representation above census levels of Black or African American and Hispanic or Latinx populations; and
  • Clinical pharmacology trials, compared with therapeutic trials, had higher percentages of Black or African American participants (37.2% vs. 17.0%) and Hispanic or Latinx participants (45.7% vs. 20.1%).
Although the analysis suggests there has been progress, the company remains committed to further fostering equity through achieving racially and ethnically diverse participation at or above US Census or disease-prevalence levels, when appropriate, in all clinical studies. This goal was met in a landmark multinational phase 3 COVID-19 trial20 that prioritized participant diversity. Clinical key activities included:
  • Selection of sites with the greatest potential for recruitment of racially and ethnically diverse participants;
  • Incorporation of diversity topics/questions into the feasibility survey and pretrial assessment;
  • Inclusion of budgetary support and lead time for the creation of diverse recruitment/patient education materials (e.g., proper translations) and mechanisms to proactively leverage services for sites to identify diverse participants; and
  • Use of Pfizer diversity tools and resources to monitor diverse recruitment in real time and establish regular meetings to assess site performance.
The trial enrolled 46,331 diverse participants at 153 trial sites globally.20 About 42% of overall and 30% of US participants had diverse backgrounds. (Figure 6).

Pfizer continues to incorporate the key activities implemented in the landmark COVID-19 trial. This includes creating partnerships and collaborating with other organizations that also prioritize appropriate representation in clinical trials. For example, in 2021, Pfizer joined with Columbia University Irving Medical Center and the Herbert Irving Comprehensive Cancer Center in establishing the Columbia-Pfizer Clinical Trials Diversity Initiative21 to reduce health disparities by increasing the participation of underrepresented minorities in clinical trials and enhancing the diversity of clinical researchers. Pfizer will provide a 3-year, $10 million grant to the university for the initiative. The initiative will expand the university’s Community Health Workers Program network to connect with underserved populations and create culturally sensitive engagement tools. The effort will also focus on identifying new ways to make clinical trials more accessible through telemedicine, wearable technology, and home visits. In addition, the initiative aims to improve diversity among clinical research faculty and staff.
The company has established the following:
  • The Pfizer Clinical Trial Diversity Center of Excellence to advocate for diversity in clinical trials (Figure 7).  
  • An epidemiology library, which is instrumental in guiding decisions on recruiting participants for clinical trials. The library supports the generation of objective enrollment goals based on an algorithm using data from the US Census, government surveys, real-world data, and literature that meet established quality criteria.  
  • A state-of-the-art interactive clinical trial dashboard to maintain a real-time record of progress. The dashboard monitors each trial and tracks metrics on recruitment, investigator training, and development of collaborator networks. It allows for transparency at all levels of the organization and is fully equipped to achieve diverse representation in clinical trials.22

These efforts are championed by Pfizer global regulatory affairs (GRA) colleagues by steering team strategy toward submitting race and ethnicity diversity plans for investigational products in development before initiation of the pivotal study. The diversity plan is:
  • Central to the company’s drug development process – concepts are incorporated into clinical development plans, operational implementation plans, and labeled as driver activities; and
  • A focus for the cross-functional leadership team (e.g., clinical, safety, regulatory, medical, clinical pharmacology, statistics) and the Pfizer Clinical Trial Diversity Center of Excellence throughout program development.
Pfizer Race and Ethnicity Diversity Plan Template
Pfizer GRA created a diversity plan template as a practical tool for driving proactive, early cross-functional team planning for inclusion of clinically relevant populations that are likely to use the drug or biologic, if approved (Table 2). The template facilitates consistency across all diversity plan submissions. It aligns with the following FDA guidances and related publications:
  • Collection of race and ethnicity data in clinical trials23
  • Enhancing the diversity of clinical trial populations – Eligibility criteria, enrollment practices, and trial designs9
  • Diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials11
  • Promoting inclusion of members of racial and ethnic minority groups in cancer drug development24

The following industry sponsor questions and considerations remain regarding the regulator position on race and ethnicity diversity plans, considering these details are not addressed in the guidance:
  • Diversity plan enrollment goals
  • Are individual clinical trial or overall program level goals to be included in the diversity plan?
  • What data sources are deemed suitable to support sponsor goal establishment?
  • How are global/multiregional clinical trial guidelines (International Council for Harmonisation guideline E17) considered?
  • What are the potential consequences of sponsor failure to achieve goals, despite best efforts?
  • Diversity plan submission and review process
  • Are there plans for a race and ethnicity diversity plan manual of policies and procedures?
  • Will race and ethnicity plans be reviewed only by the appropriate review division and/or a specified review committee?
  • Are the concepts outlined in the FDA race and ethnicity diversity plan guidance also applicable to products under review by the Center for Biologics Evaluation and Research?
  • What are the agency expectations for product development in rare disease settings?
  • What are appropriate triggers for race and ethnicity diversity plan updates?
Key highlights from the panel discussion
  • According to FDA staff,25 medical product sponsors should focus on enrolling diverse patient populations in clinical trials, rather than on terminology around race and ethnicity. Comments included:
  • “The big picture here is that we want to enroll a population that reflects the diversity of the population that will use the drug once it’s approved.”
  • “Race and ethnicity [are] just one factor among many other factors to be considered in enrolling that diverse population.”
  • From an FDA representative perspective,25 a common practice is for sponsors to collect demographic data by patient self-report. Variations by country are expected. Sponsors should do their due diligence in enrolling a diverse population and collecting race, ethnicity, and ancestry information at a granular level. Comments included:
  • “This is not a new problem.”
  • “We have not been focusing on this issue in [a] comprehensive fashion to really [be able to] implement sustainable, action-driven strategies to enroll a diverse population.”
  • “There’s a lot of learning to be done here, on both sides. The regulators don’t have all the answers; the sponsors don’t have all the answers.”
  • Inclusive and flexible approaches play a key role in enhancing clinical trial diversity. Pfizer’s experience suggests that the following is impactful: Proactively assessing the potential challenges posed by site visit schedules, and expanding site visit windows, as appropriate, to allow for less patient burden (e.g., align frequency with routine patient care appointments) and associated travel expenses; incorporating decentralized modalities, such as the use of electronic communications and wearable digital technology to support remote monitoring in lieu of in-person site visits.
  • Rebuilding and developing trust in the clinical trial system is imperative to achieving diversity and health equity. One component of Pfizer’s effort toward this goal is securing collaborative partnerships with key institutions and groups that have a similar equity purpose to fostering proactive community engagement.
Meaningful representation in clinical trials for regulated medical products is fundamental to achieving equity and reducing healthcare disparities. Lack of representation of diverse populations in clinical trials, underpinned by existing barriers and lack of proactive planning to set and achieve appropriate enrollment goals, is not a new challenge. Solving the issue cannot be achieved by one organization or stakeholder group. It will require the involvement and participation of the entire medical product development ecosystem. The collaborative discussion at the 2022 RAPS Convergence among FDA, Health Canada, and industry is one such endeavor of many toward this effort. The meeting resulted in greater understanding and appreciation of perspectives. It also revealed that, while stakeholders have different roles and responsibilities, their common goal is achieving health equity for all.
About the authors
Mathilda Fienkeng, PharmD, MS, RAC, is the director of the Division of Medical Policy Development in the Center for Drug Evaluation and Research’s Office of Medical Policy at FDA, where she leads a diverse staff of medical, pharmacy, nursing, public health, legal, project management and administrative professionals in new and ongoing policy initiatives pertaining to human drug development, human drug approval, bioresearch monitoring, and human subject protection. Fienkeng has been with FDA for 14 years. She has public health experience in prescription drug advertising and promotional labeling review, surveillance and enforcement, drug shortage, and domestic and international emergency response. Before joining the agency, Fienkeng worked as a registered nurse and a high-school teacher. She has a Doctor of Pharmacy degree and a master’s degree in regulatory science from the University of Maryland School of Pharmacy; an executive certificate in public policy from the Harvard Kennedy School of Executive Education; an associate degree in nursing from Essex Community College, and a Bachelor of Arts degree in bilingual education from Ecole Normale Supérieure, University of Yaoundé, Cameroon. She can be contacted at mathilda.fienkeng@fda.hhs.gov 

Alysha Croker, PhD, is the director of the Centre for Policy, Pediatrics, and International Collaboration at Health Canada, a role that includes developing ways to integrate equity considerations across the drug and medical device lifecycle. She previously managed the Canada Excellence Research Chair and the Canada First Research Excellence Fund programs and led the development of the Canadian Institutes of Health Research's training and equity strategies for which she was awarded the CIHR innovation award. Croker has a PhD from Western University, where she studied the molecular mechanisms of breast cancer metastasis and therapy resistance. She can be contacted at alysha.croker@hc-sc.gc.ca
Zaida Recinos-Vasquez, MS, MS, is a manager, global regulatory strategy lead in the Pfizer global regulatory affairs (GRA) chemistry, manufacturing, and controls (CMC) oncology group. She leads diversity, equity, and inclusion initiatives across Pfizer, including the Global Regulatory Equity in Action Team Diversity Plan template. She lectures in a graduate-level pharmaceutical regulatory affairs course and the Pfizer GRA Regulatory 101 Training Academy. Recinos-Vasquez is an active member on both the Pfizer Latino and Global Black Community Colleague Resource Groups. She has experience in postmarket approval regulatory strategies for a range of therapeutic areas. Before joining CMC at Pfizer, Recinos-Vasquez worked in diverse roles within quality and technical services that spanned from clinical to commercial stage of solid and liquid dosage forms. She holds masters of science degrees in pharmaceutical manufacturing from Stevens Institute of Technology, NJ, and quality assurance/regulatory affairs from Temple University, PA. She is a Pfizer Enterprise RAPS member and can be contacted at Zaida.recinos@pfizer.com
Monique Carter, MS, RAC, FRAPS, is a senior director, global regulatory strategy lead in the Pfizer GRA internal medicine group. She leads multiple diversity, equity, and inclusion initiatives and programs across Pfizer including the Global Regulatory Equity in Action Team as well as the Pfizer-Collegeville Global Black Community Colleague Resource Group. She is the founder and director of the Pfizer GRA Historically Black College/University Preceptorship Program and the GRA Regulatory 101 Training Academy. Carter leads innovative and adaptive drug development regulatory strategies, ranging from the early investigational space through postmarket approval, to support the continued access to safe and effective medicines for patients in need. She is a graduate-level adjunct lecturer of pharmaceutical regulatory affairs, a RAPS Fellow (FRAPS), holds the Regulatory Affairs Certification (RAC), and is a Pfizer Enterprise RAPS member. She can be contacted at Monique.Carter@Pfizer.com
Acknowledgment This article includes a summary of the content presented at 2022 RAPS Convergence in Phoenix, Arizona, on 13 September 2022. Speakers included the authors of this article – Mathilda Fienkeng, Alysha Croker, Zaida Recinos-Vasquez, and Monique Carter – and panelist Lola Fashoyin-Aje, MD, MPH, deputy division director and associate director of FDA’s Oncology Center of Excellence.
Randolph Fillmore assisted in the preparation of the article. He can be reached at flasciencewriter@gmail.com
Disclaimer Alysha Croker is a full-time employee of Health Canada. Mathilda Fienkeng is a full-time employee of FDA. Zaida Recinos-Vasquez and Monique Carter are full-time employees of Pfizer Inc. The opinions expressed in this manuscript are the authors’ own and do not reflect the views of their organizations and may not be understood or quoted as being made on behalf of, or reflecting the position of, the organization with which the authors are affiliated.
Citation Fienkeng M, et al. Enhancing diversity in clinical trial populations: An agency-industry perspective. Regulatory Focus. Published online 31 December 2022. https://www.raps.org/news-and-articles/news-articles/2022/12/enhancing-diversity-in-clinical-trial-populations
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