The COVID-19 pandemic has exposed a number of persistent healthcare challenges that societies are now seeking to address and overcome. Among them is a disproportionately high rate of COVID infections, symptom severity and mortality among certain ethnic or racial groups – an issue that has brought to the surface the critical importance of diversity in clinical research.
Why is diversity so important when evaluating potential new medications for COVID or for any therapeutic indication? An established body of scientific evidence clearly demonstrates that certain ethic and racial populations are more severely affected by a variety of health conditions such as cardiovascular disease, type II diabetes, stroke and certain cancers. The lack of diversity among clinical trial participants leads to the approval of medicines and vaccines that have not been tested for safety and efficacy in high-risk populations and which may not effectively treat the majority of people affected by condition. In other words, clinical research data should reflect the populations that medications are designed to treat.
Especially in India, one of the world’s most ethnically and culturally diverse nations, it is essential to include more diverse populations in clinical trials. By improving access to clinical trials, we would greatly expand the pool of available research participants so that patient recruitment would become faster and more efficient. This would shorten trial timelines, accelerate trial completion and ultimately speed the development of new drugs to those who need them. Improving diversity is therefore not just a nice idea but an ethical and business imperative.
Best practices for enhancing diversity in clinical trials include:
- Working with diverse community leaders to share trial messaging with their respective community members
- Collaborating with patient recruitment vendors that are owned by individuals from diverse backgrounds to draw upon their expertise
- Providing clear and simple educational materials in a variety of languages
- Providing cultural awareness training for site staff
- Engaging patients from a variety of backgrounds via patient advisory councils to learn from their experiences and perspectives on trial participation
- Sharing testimonials from people of similar demographics who can speak to their experiences and reinforce the value of their participation in advancing the development of new therapies that could help their respective communities reduce acute and chronic disease
Parexel has initiated or is contributing expertise to multiple initiatives to enhance diversity in clinical trials, including:
- As part of our collaboration with the Society for Clinical Research Sites (SCRS), we are contributing to the SCRS Diversity Initiative, which is focused on addressing the challenges and opportunities at clinical trial sites while exploring the needs of diverse patient populations in clinical research.
- Parexel has joined the recently established Cross Sponsor/CRO Collaborative on Diversity & Inclusion in Clinical Trials, which is focused on promoting greater education and awareness about clinical trials and enhancing trust at the community level
- Parexel’s Patient Advisory Council is actively working to address the issue of diversity by hosting periodic forums to collect feedback and thus learn from patients of different racial, ethnic, cultural and linguistic backgrounds to understand exactly how we can improve their trial access and experience.
- Parexel has rapidly incorporated decentralized clinical trials (DCT) and hybrid approaches to bring trials to patients rather than patients to the study. Through telehealth visits, wearable devices, home nurse visits, smartphone apps and direct-to-patient drug shipments, more patients can participate in clinical trials from their homes or local communities without the burden of traveling to distant study sites or missing work and school to attend study visits. This increases access to among individuals – and more diverse individuals – who previously were unable to participate. Currently, Parexel is supporting more than 100 DCTs around the world.
Ultimately, the goal is to expand access to individuals who have traditionally been underrepresented in clinical research while also partnering with them to understand their needs, concerns and barriers to trial participation.