Medicines affect various populations differently, so it is essential to have a diverse population when recruiting for clinical trials. Although specific patient recruitment tactics can be successfully deployed to reach certain sub-groups, there is a pervasive population disproportion in clinical trial participants. Such an understanding is the initial step to conquering the problem of minority recruitment. Once the gap is identified, the next and most difficult step is to implement actions designed to close the gap.
In the past, it was extremely difficult to ascertain the demographic breakdown of those participating in clinical trials. Although data was available to the public, there wasn’t a place available to access the demographic breakdown of clinical trial participants.
Many patients questioned whether the medicine they took was tested on someone with similar demographics before it was approved. In response to questions by concerned parties who cited Section 907 of the 2012 FDA Safety and Innovation Act, the FDA publicized strategies in August 2014 to gather and make accessible clinical trial patient populations according to sex, race/ethnicity or age. The resulted in the “Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data.” It prioritizes making demographic data from clinical trials more accessible and transparent to the public.
With the vital need for both the availability and transparency of clinical trial participants, the FDA launched the website Drug Trial Snapshots. This site was designed to provide demographic data to the public, showing who participated in the research studies which data supported approval of a particular medicine. For example, an Asian woman may want to know how many Asian women participated in clinical trials that led to an approval of the medicine that has been prescribed. She may also wonder whether her doctor knows this information. In most cases, doctors do not. Although the physician may be familiar with the package insert that accompanies the prescription, which has a lot of in-depth information on the mechanism of the action, there is not information pertaining to the demographic makeup of the people who participated in the clinical trials.
Making this information accessible is wonderful, but does it really matter? If the medicine is approved and has been tested, is that enough? The question is different for each medicine and each sub-group.
In one example for a particular medicine, the Snapshots website reveals that there is a higher risk of bleeding in women. Another example states that a medicine has greater efficacy in women and Asian persons. Interestingly, in both instances the label either does not mention gender differences at all or is inconsistent with the information on the Snapshots website.
Figure 1 shows that there are measurable differences pertaining to how medication responds when used by persons of different ethnicities. The issue is not new but warrants fresh attention. As far back as 1988, there have been documented clinical differences in responses to antihypertensive drugs based on race/ethnicity. Keep in mind that diversity is not specific to race or gender.
An evaluation published by the British Medical Journal revealed that elderly patients were part of the exclusion criteria for nearly a third of trial protocols, yet said elderly patients make up more than a third of the population that would ultimately benefit from the use of those drugs in practice.
There are multiple ways to ensure diversity in clinical trial participation. Although patient recruitment strategies can ensure that diverse audiences are aware of a trial, patient diversity should be considered during protocol design. For example, if the protocol excludes patients over 65 years of age, yet the medication will be taken by older people, the protocol should take that into account. Targeted advertising and other outreach campaigns designed to reach outlying sub-groups are often effective. Patient advocacy groups can also aid in spreading awareness. Underrepresentation of sub-groups in clinical trials is an issue that can have far-reaching effects. The gap has now been identified and diversity in recruitment of clinical trials warrants immediate consideration.
Ashley Tointon has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry. She currently provides recruitment expertise, strategy and leadership as Principal Consultant of Accelerate Clinical Enrollment LLC. Email comments and suggestions to firstname.lastname@example.org.
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