Clinical trials are essential for the development of new treatments and therapies. But in order for the outcomes of clinical trials to reach the target population, they need to include a representative sample of participants. Many trials are limited to a homogenous group of participants representing a specific racial, ethnic, sociodemographic, and geographically restricted portion of the target population. Without including representative samples from the onset of drug and other treatment development, there is a risk that the results of a trial may not be applicable to all patients, which could lead to ineffective treatments.
Clinical trial diversity is the inclusion of a heterogeneous group of participants in clinical trials, with the goal of ensuring that the results of the trial are applicable to a wide range of patients. This includes people of different ages, races, genders, and other demographic characteristics. Exclusion criteria for many clinical trials are overly restrictive, excluding potential participants with different medical conditions, disabilities, and psychiatric diagnoses and restricting the range of cognitive abilities. Thus, the resulting sample is often not representative of the people the new therapies are aiming to treat.
Clinical trial diversity is important for a number of reasons. It helps to ensure that the results of a trial are generalizable to the population as a whole. It helps to ensure that all patients have an equal opportunity to participate in trials and receive the potential benefits of new treatments. It helps to ensure that the data collected in a trial is of high quality. Further, if a treatment is only tested on one group of patients, any side effects or adverse reactions may not be discovered until the treatment is used on a more diverse population.
There are a variety of challenges that need to be overcome in order to achieve clinical trial diversity. First, there is a need to increase awareness of the importance of diversity in clinical trials. This can be done through education, outreach efforts, and regulatory policies that require representation in clinical trials. Second, there is a need to increase the number of people from diverse backgrounds who are willing to participate in clinical trials. There are several barriers to participation in clinical trials by people from underrepresented backgrounds, including time and transportation to the clinical trial site (most clinical trials occur in a major metropolitan area, limiting the feasibility of people from rural areas to participate), along with financial limitations and lack of access to childcare. Fully remote assessments for clinical trials using platforms like NeuroUX can reduce these barriers to participation and increase participation by diverse communities. The NeuroUX team has helped numerous research groups transition from lab-based to fully remote studies. Third, there is a need to ensure that clinical trials are designed in a way that makes them accessible to a wide range of people. This can be done through the use of innovative trial designs and the use of technology.
To achieve health equity, we need clinical trial diversity. The FDA’s new guidance on clinical trial diversity recommends that sponsors consider enrolling a diverse population of patients in their trials. The guidance also recommends that clinical trial designs take into account the potential for different responses to treatments based on race and ethnicity. This is a welcome development, as it will help to ensure that new treatments are effective and safe for all patients.