Imagine the following: you get sick, visit your doctor, get prescribed a medication, you take it, and get better. Simple right? It may seem simple, but behind the scenes it takes years for new medications to be approved by the FDA, Health Canada and their equivalents in other countries. The process to get new medications approved is lengthy and tedious, and includes multiple phases of clinical trials.
Clinical trials are necessary to evaluate the effectiveness and safety of new treatments. The data collected during trials needs to have high level of generalizability to the general public. This means that the research results should represent any individual in the population. In order for the data to be fully representative, the trial must include individuals from varied demographics. This includes different ethnicities, sexes, ages, and lifestyles, so that when the treatment hits the market, it can be safely prescribed to anyone.
Diversity in Clinical Research
If you get prescribed with a certain medication, and you are a member of a minority ethnic group, or have a genetic predisposition not common in the general population, it may put you at ease to know that someone similar to yourself has previously taken this medication, and responded well to it.
Unfortunately, the current state of clinical research has a disproportionate skew of majority demographics, lowering the diverse representation of clinical research participation. Historically, many ethnic and racial minorities have been underrepresented in research. This has also been noticed in recent times and raises many concerns. The lack of diversity in clinical trials is a moral, scientific and medical issue, and can have seriously dangerous repercussions!
It is known that different subgroups may react differently to a therapy; for example, women may respond differently to a drug than males. A review done by the Food and Drug administration (FDA) found that 20% of the drugs approved between 2008-2013 had different responses between racial or ethnic groups.
Another report from 2011, found that Hispanics and African Americans comprise 16% and 12% of the US population, but only comprise 1% and 5% of trail participants respectively (as further visualized by the graph below). A Canadian example; it’s been reported that 82.3% of participants in cancer trials identified as Caucasian, even though Caucasians represent 69.8% of the Canadian population.
How to narrow the gap?
Addressing the lack of diversity in clinical trials can be done by increasing both access to healthcare, and the willingness of underrepresented groups to participate in research. In the past, minority groups may have developed distrust in clinical trials, for example through infamous events as the Tuskegee Syphilis Study. Therefore, first and foremost, the healthcare industry as a whole must provide reassurance by re-structuring the system to accommodate all individuals.
Practical ways to do so in research include; the promotion of research in different mediums such as online and in different suburban, urban, and rural climates. It may also help to widen eligibility criteria’s and put more time towards building inclusive clinical trial designs; perhaps making cohorts of different demographics to ensure that a certain number of individuals from different racial groups are included.
Beyond that, it also has been recommended to utilize community medical centres, especially in low socio-economic neighbourhoods, to accommodate patient procedures; thereby reducing the burden of travel and time on participants in these areas. Technology can also be used to transfer unnecessary patient procedures to a remote setting.
Also, in order to find participants from minority demographics, it is wise to reach out to patient advocacy groups and create a working relationship with representatives to see what needs have to be met in order to increase participation. Once diversity is made a forefront initiative of research and healthcare, we believe that the general well-being of the population will be improved.
Are you interested in joining the conversation on how to increase diversity in clinical research? Or do you want to participate in a clinical study? Please reach out to us at eva@medicalartsresearch.com.