Yesterday, PhRMA published first ever industry-wide principles on clinical trial diversity, a new chapter in the already existing “Principles on Conduct of Clinical Trials & Communication of Clinical Trial Results.” These new principles have been approved by the PhRMA Board of Directors and will take effect in April 2021.
Critical to enhancing clinical trial diversity is addressing the systemic issues that deter mainly Black and Brown communities from participating in clinical trials, so that those who want to participate, can. We are working toward making our industry consistent in building and bridging a deficit in trustworthiness to better meet the needs of the communities we serve. Our new clinical trial diversity principle addresses:
- Building Trust and Acknowledging Past Wrongs. Some patients may not trust medical research due to the historic record of mistreatment, including from the U.S. Public Health Service Tuskegee Syphilis Study and the exploitation of Henrietta Lacks, whose cancer cells were harvested without her knowledge and have been used over the decades since. Today, patients and research participants’ rights are protected by law and ethics committees, including institutional review boards that oversee clinical trials. Our companies are also committed to enhancing diversity among clinical investigators, working with communities to educate about the role of clinical trials and improving our community outreach so that those who want to participate can do so.
- Reducing Barriers to Clinical Trial Access. To enhance clinical trial diversity, it is imperative for researchers to plan studies and development programs that promote inclusion of diverse populations, implement protocols that define the intended treatment and enrollment populations and seek input from those communities throughout the process. For example, sponsors should consider recruitment challenges and enrollment barriers that may occur as a result of factors such as planned visit schedules, location and financial implications, as well as how these factors might be addressed. It’s also important that researchers adopt practices for determining science-based eligibility criteria that do not inhibit the diversity of the clinical trial population.
- Using Real-World Data to Enhance Information on Diverse Populations Beyond Product Approval. During the post-approval phase, collecting clinical real-world data or evidence can be an important method of supplementing trial data, in compliance with all applicable local laws and regulations. These data can also serve as an effective and efficient means to enhancing understanding of drug effects in diverse patient populations.
- Enhancing Information About Diversity and Inclusion in Clinical Trial Participation. Lastly, biopharmaceutical companies that adopt these new principles commit to sharing information about their policies or practices to increase clinical trial diversity online to promote transparency and accountability.
At the core of these principles is the need for the industry to better serve historically underserved populations. By committing to enhancing diversity in clinical trial populations, we can better reflect the patients that will use the new therapy or medicine being studied and solve for improved health outcomes. For example, different populations may be at higher risk for certain diseases, such as sickle cell disease, diabetes or heart disease. Clinical trials for the development of new medicines for those diseases should aim to reflect the patient population they are aiming to help. Ultimately, diverse clinical trials support a better understanding of the medicine. This is one way the industry can improve the care for the patients we serve.
It is with these core principles in mind that the biopharmaceutical industry commits to continuing to work with patients, patient advocacy groups, regulatory authorities, health care practitioners, academics and policymakers to define the systematic and impactful approaches that can enhance the diversity of clinical trial participants and help reduce health care disparities.
Learn more about these efforts at phrma.org/equity.
Richard Moscicki M D
Dr. Moscicki served as executive vice president, Science and Regulatory Advocacy and chief medical officer at PhRMA from 2017-summer of 2022. He joined the organization after serving as the Deputy Center Director for Science Operations for the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) since 2013. While at FDA, Dr. Moscicki brought executive direction of Center operations and leadership in overseeing the development, implementation, and direction of CDER’s programs. Previous positions include serving as Chief Medical Officer at Genzyme Corporation from 1992 to 2011, where he was responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company. He served as the senior vice president and head of Clinical Development at Sanofi-Genzyme from 2011-2013.
Richard Moscicki M D
ICYMI: PhRMA submits comments to White House on artificial intelligence
New research: Industry sponsored clinical trials contribute billions to state economies
Recent events highlight progress on health equity
ICYMI: PhRMA’s 4th Annual Pathways to Success: Virtual STEM Career Expo
Hispanic Heritage Month: Fighting for Hispanic patients
PhRMA awards grants to 2024 Annual Pathways to Success: Virtual STEM Career Expo Partners
How government price setting fails to address systemic health care inequities
Women’s Health Month: A conversation with Sage
Championing cancer equity: Our drive for healthier AANHPI communities
New analysis: Accelerated approval pathway is changing lives in underserved communities
ICYMI: More evidence of the IRA’s harmful consequences on post-approval research and development
PhRMA provides grant funding to support the Morehouse School of Medicine Satcher Health Leadership Institute’s Health Equity Tra
New social determinants of health simulation explores structural barriers patients face accessing and affording medicines
PhRMA awards grants to 2023 Annual Pathways to Success Graduate Summit Partners
Decentralized clinical trials and the future of drug development
Between hope and despair: Improving cancer outcomes
ICYMI: PhRMA CMO Dr. Michael Ybarra speaks with Dr. Fabian Sandoval about clinical trial diversity
PhRMA awards grant to Emerson Diversity Health Foundation
PhRMA Otorga Beca a la “Emerson Diversity Health Foundation”
PhRMA submits comments to OSTP on enhancing clinical trial diversity
Using traditional HTAs to determine coverage threatens patient access to medicine
Traditional HTAs keep diverse patients out of the conversation
Traditional HTA methods treat everyone like the “average” patient
You won’t fix what you don’t value: Two reasons why traditional cost-effective analyses can perpetuate health inequities
Potential gene therapies bring hope to patients with sickle cell disease
Stephanie Dyson of BMS on reducing health disparities
Sharing rebates can save Americans with diabetes 500 each year and improve adherence
Announcing CAREs Grant Round 4
Announcing CAREs Grant Round 4
Guest Series: PhRMA talks racial and health equity with Lauren Powell, VP US Health Equity and Community Wellness, Takeda
PhRMA awards $75,000 to fund initiatives to reduce health inequities
Watch: Building trust and enhancing clinical trial diversity
More than 800 medicines are in development for diseases that disproportionately affect racial and ethnic communities
PhRMA hosts first stakeholder workshop on clinical trial diversity
PhRMA CAREs Grant request for proposals: Addressing inequities in access to COVID-19 testing, therapeutics and vaccines
PhRMA member companies share how they are improving clinical trial diversity
Guest post: PhRMA talks racial and health equity with Stephanie Dyson, Head of Office at Biogen
Paper finds gaps in health data are a barrier to health equity
New research shows hotspots of inequity relate to increased COVID-19 hospitalizations
Increasing diversity at investigator sites could increase minority participation in clinical trials
Report highlights biopharmaceutical industry’s commitment to D&I
Strengthening a culture dedicated to patients and equity: A conversation with Percival Barretto-Ko, President of Astellas US
PhRMA CAREs Grant request for proposals: Addressing racial disparities in medication utilization and adherence
Committing to diversity, equity and inclusion: A call to action for clinical trials
ICYMI: Addressing health inequities: Biopharmaceutical companies are rising to the occasion
Guest Post: Honoring Hispanic Heritage Month by taking action on health equity
Sharing rebates can improve access to medicines and increase health equity
PhRMA will continue to advocate for equity within our industry
Three ways the pharmaceutical industry can positively impact health equity
Guest Post: Amgen Foundation stands for equal opportunities in STEM learning
Systemic racism is as real as any disease, and our industry is not immune
Guest Post: Pride started with protest: Combatting the dual pandemics of COVID-19 and racism this Pride Month
How biopharmaceutical researchers are ensuring COVID-19 vaccines will be safe and effective
PhRMA awards $100,000 to fund projects that address health inequalities
Clinical Trials Awareness Week: Recognizing unsung heroes in medical research
Guest Post: Preserving clinical research sites during the coronavirus pandemic
Observing National Minority Health Month in the age of COVID-19
The biopharmaceutical industry’s unique role in responding to COVID-19
COVID-19 Response: Supporting the frontline
America’s biopharmaceutical companies are working around the clock to beat coronavirus
ICYMI: America’s biopharmaceutical companies are taking on COVID-19
Clinical Trials Awareness Week: Celebrating innovation in clinical research
Clinical trials impact state economies
Examining the truth behind clinical trial costs
New report details the setbacks and challenges to Alzheimer’s research
Guest post: Ensuring communities have a seat at the table: The importance of diversity in clinical trials
Bringing innovation to clinical trial design
EFPIA-PhRMA Principles successfully enable responsible clinical trial data sharing
Guest Post: Film chronicles clinical trials ‘paying it forward’
Biopharmaceutical industry policies aim to increase access to clinical trial data
Guest Post: The Clinical trial experience from a patient & researcher perspective
Guest Post: Patients as research partners - Rethinking patient access to clinical trial data
Guest Post: Spotlighting the heroes in clinical trials
Guest Post: Advancing oncology research through clinical trials
Clinical Trials Awareness Week: Celebrating the impact of clinical research
Driving innovation through collaboration
Watch: Biomarkers in drug development with Dr. Bernie Zeiher
Just released: PhRMA members’ new clinical trial diversity principles
Clinical Trials
Health Equity
Just released: PhRMA members’ new clinical trial diversity principles
Just released: PhRMA members’ new clinical trial diversity principles