In a recent blog post, we talked about the diversity issue in clinical trials and the negative impact it has on research. Now, let’s address some practical ways pharma companies can apply to improve clinical trial diversity. The good news is that many organizations and individuals are interested in addressing the problem and the COVID-19 pandemic response has put a laser focus on the area.
So what are 4 tangible takeaways that pharma can apply right now?
- Widen eligibility criteria
Plan for diversity from day one as your research begins to take shape. It can’t be achieved haphazardly or in the eleventh hour. Ensure to map out wider eligibility criteria earlier in the drug development process so that it is thought about in Phase 1 and not just Phase 3. It might be difficult to place focus on inclusive clinical trial design when achieving proof of concept and securing investor engagement is top of mind, but it must be done if the diversity issue is going to be tackled.
- Look for diversity in your site and investigator selections
Don’t just look for diverse patients. Look for diversity in your site and investigator selections. Yes, sponsors often focus on large research or academic facilities due to their credentials and trial experience, but what about patient communities that live away from larger cities without large research sites available easily? For patients from rural communities, it may not be financially feasible to commit to travel to bigger cities for visits if they need to take time off work. This is especially true when some protocols require a high frequency of visits. Consider working with smaller community-based medical centers who understand their local community and may be happy to offer their patients new treatments. They may become your trials best recruiter.
- Use technology to reduce the patient burden
Think about how you can implement or use home-based and telemedicine technologies to enable the expansion of your trial into underrepresented areas and reduce the participation barriers of cost, availability, and distance from the trial site. If trials are more accessible, this will help to improve access for patients otherwise impeded to taking part.
- Connect with advocacy groups
Patient advocacy groups are a direct link to your patient population. If you work in the rare disease space, this is an essential component of your trials success. Think about the best ways to build meaningful relationships with patient advocacy groups. Often these groups are very open to receiving educational materials about new investigational products and upcoming trials, and are engaged in disease awareness campaigns that the sponsor can get involved with. For some indications, advocacy groups are the first place patients go to for information about their condition.
Supporting Guidance to Help
The US Food and Drug Administration (FDA) is among the organizations concerned and working to effect change. A great place to learn more about increasing diversity in clinical trials is the FDA’s Office of Minority Health and Health Equity. The Agency recently issued a new guidance on “enhancing the diversity of clinical trial populations.” A final version of a draft guidance the Agency issued in 2019, it recommends approaches that sponsors might take to increase enrollment of underrepresented populations, including not only racial and ethnic minorities, but also children, adolescents, and women.
The Pharmaceutical Research and Manufacturers of America (PhRMA), the pharmaceutical industry’s largest trade group, also made news recently when it also released guidelines aimed at enhancing racial and ethnic diversity among participants in clinical trials.