Only about 5% of eligible participants are recruited for a given trial, and insufficient recruitment is a major cause of trials ending prematurely1. Additionally, the proportion of participants in underrepresented groups is substantially smaller than the proportion of the general population in these groups. The FDA reports that for clinical trials conducted between 2015-2019, an average of 7% of participants were black, 11% were Asian, and 13% were hispanic2. This is a major issue since many diseases and treatments show differences between sexes and among ethnic groups!
What is driving these issues? Can anything be done to overcome them?
Geography is a major barrier. Most clinical trial centers are located in urban areas, which means long commutes for those living in rural areas. Even for those in urban areas, traveling to a main center for check-ins and procedures is a significant time commitment, and this tends to be disproportionately challenging for those in underrepresented groups. Child care and less flexibility with work schedules or access to transportation can be major barriers for women, ethnic minorities, or low-income individuals.
An unexpected benefit of the changes forced by the COVID-19 pandemic was a switch to decentralized clinical trials (DCTs). DCTs typically involve telehealth check-ins, and monitoring or treatments can be done either at home or at a local clinic. This means long-commutes are not a barrier for participating in these studies, and check-ins/treatments can be designed to fit into a participant’s normal routine.
A 2020 analysis3 assessing diversity in virtual DCT versus traditional clinical trials found that virtual DCTs had higher levels of female participants than traditional trials. It also found that virtual DCTs recruited participants from over 20 different states! This is a substantial improvement since traditional clinical trials typically only recruit participants from a single state. Additionally, the virtual DCTs took about 4 months to recruit participants, whereas the traditional clinical trials took an average of about 16 months to recruit participants.
Another benefit of DCTs is the use of electronic informed consent. Many people, especially those in underrepresented groups, have complicated relationships with the medical system and are wary of participating in clinical trials. Electronic informed consent allows potential participants to go through the material at their own pace. This makes the process more comfortable since people don’t feel rushed or pressured in deciding whether or not to participate.
DCTs are not a cure all for boosting diversity, and ongoing work is needed to break down the barriers of structural racism and the need for internet access, but they are a helpful first step. Continued work to improve recruitment will further reduce barriers and help them to be even more reflective of the population that will benefit from the therapeutics being developed.
The switch from traditional clinical trials to DCTs does pose challenges for companies. The need for infrastructure changes and expertise in performing these types of trials can be intimidating.
Thankfully, the forced switch to DCTs as a result of the COVID-19 pandemic meant that many clinical trial outsourcing partners have the required infrastructure and expertise. CROs provided DCT services early on in the pandemic that contributed a lot to timely vaccine development. For example, IQVIA offered DCT services to Janssen Pharmaceuticals, which led to the Johnson & Johnson vaccine getting approved.
Going forward, these CROs can provide either a temporary solution as companies develop in-house infrastructure and acquire expertise, or a long-term solution since outsourcing DCTs may be less costly than outsourcing traditional clinical trials4.