Today, May 20, is recognized as International Clinical Trials Day. Established in 2005, the event aims to recognize all those involved in clinical trials—from patients to sites, sponsors, and all those who operate trials—and spread awareness on how important clinical research and development are in advancing innovative medicines and treatments. This year’s International Clinical Trials Day theme is “We Rise,” a fitting theme given what our world’s been going through responding to the pandemic.
COVID-19 catalyzed astounding progress in research and development. We witnessed remarkable innovation and unparalleled collaboration as our industry rose to the occasion throughout this past year. As Pfizer CEO Albert Bourla recently stated, “The pandemic was the ultimate test of the pharmaceutical industry’s credibility and relevance.” We’ve proven that even moon-shot challenges can be achieved when we work together openly and align to the right mission. On this special day, we should take a moment to recognize the remarkable achievement by countless colleagues involved in the unprecedented scientific development and collaboration by AstraZeneca, Johnson & Johnson, Moderna, and Pfizer/BioNTech to deliver COVID-19 vaccines in an unprecedented time frame.
Yet at the same time, we cannot settle for the status quo. We have much more work to do as an industry. We must keep driving meaningful change forward in clinical research.
Diversity of Participants in Clinical Trials
Clinical research is foundational in developing and advancing innovative medicines, yet certain racial minority groups continue to be underrepresented in clinical research. The lack of diversity in clinical trials remains a key barrier in achieving equitable health outcomes for all. Historically, many trials did not even report data on race and ethnicity.
Not willing to settling for status quo, TransCelerate BioPharma is seeing many of our members taking measures to tackle this challenge head on, starting with establishing a transparent baseline. In an April 2020 report by Pfizer, analysis from 213 trials initiated in the U.S. from 2011 to 2020 showed that while Blacks or African Americans were represented at U.S. census level in overall trial participation (14.3% vs. 13.4%), Black and Hispanic or Latino participants were underrepresented, especially in cancer-related studies. In the Pfizer data, therapeutic trials had an over-representation of White participants at 78.6%, with Black participants at 17% and Asian participants only at 2.2%. I am greatly heartened to see pharmaceutical companies taking actions, starting by being transparent of their baseline data, so we can begin to take measures to meaningfully improve diversity in clinical trials.
The time to act is now. Our industry is in the midst of a monumental shift to modernize, as the COVID pandemic has forced us to think out of the box, embrace new ways of working and tackle some of the most arduous tasks head on. Diverse trial participants are crucial for researchers to fully understand safety and efficacy profiles across various racial and ethnic sub-groups. Our ultimate goal is to develop innovative medicines and treatments for ALL patients. We have both a societal and scientific obligation to push further than what we are doing today.
As COO of TransCelerate BioPharma, I am doing my part to rise to the occasion in improving awareness and access to clinical trials for all patients. I am excited to announce the launch of TransCelerate’s newest initiative, Diversity of Participants in Clinical Trials.
In 2014, TransCelerate conducted a Clinical Trial Diversification Initiative to promote awareness of the need for increased diversity and provide recommendations for sites and sponsors to facilitate greater trial participation by diverse populations through the delivery of targeted best practice materials.
Since then, we have observed increased industry, social, and global recognition of underrepresentation in clinical trials. The newly launched Diversity of Participants in Clinical Trials Initiative seeks to move beyond prior awareness-building activities and aims to equip sponsors and ecosystem stakeholders with actionable tools and resources necessary to improve outcomes for diversification of participants in clinical trials.
TransCelerate’s new Diversity of Participants in Clinical Trials Initiative is kicking its first phase off with three components:
- Clinical Research Diversity Collaboration Hub. This “one-stop shop” will collect and share information and insights across the ecosystem and include diversity roundtable events, experience-based guidance for sponsors, diversity regulation landscape assessment, and development of a pragmatic toolkit inclusive of templates and tools to be leveraged by the broader ecosystem.
- Scaling Proven Solutions. We will continue to enhance practical solutions that we have already delivered to the ecosystem for clinical research use with diverse populations. For example, our Patient Experience Initiative’s Study Participant Feedback Questionnaire has been implemented in multiple global clinical trials. Since its release in 2019 it has been translated into over 15 languages for use with multiple patient populations
- Race & Ethnicity Enrollment Data Benchmarking. TransCelerate BioPharma and its 20 Member Companies will work to identify priority disease states with disparity between disease prevalence and clinical study representation among racial or ethnic groups in order to establish a current state benchmark for tracking future progress
If we all rise and do our part, I am optimistic that the next 20 years of my career will have as many, if not more, of these exciting developments that advance medicine, eliminate diseases, and improve public health access and equity. What role are you playing in clinical trial diversification?
Janice Chang is the Chief Operating Officer at TransCelerate BioPharma Inc. Janice has been involved with the organization since its inception. In her current position, Janice works closely with the CEO and the Board of Directors to shape the long-term strategic vision and priorities for the organization and its 30+ initiatives. Janice defines and guides TransCelerate’s overall external engagement strategy with global health authorities, governmental agencies, industry groups, and TransCelerate’s country network spanning across 30 countries. She has accountability overseeing TransCelerate’s corporate operations and works closely with her team to drive strategic delivery of TransCelerate’s portfolio.