Clinical trials are carefully designed research studies that evaluate the effect of potential new treatments on humans. The participants are volunteers of all ages (including children), sexes, races, and ethnicities, usually belonging to more than one medical institution in more than one country. We would expect that these trials represent the typical population of people that are going to be treated in real-life. The reality though is quite different.
A 2018 analysis of drug studies, published in Nature, examined data on trials that led to FDA approvals between 1994 and 2014. The findings showed that African and African-American participants ranged from 1.8 to 3.5% in the trials of the period examined, while Asians were represented by 0-7%.
A 2019 research presented in JAMA Oncology highlights the disparities in race reported in clinical trials that led to drug approvals in the cancer field, for the period 2008-2018. Of the 230 trials reported, 63% included any information about the participant’s race. According to the data, 76.3% of the trial participants were white, 18.3% Black, 3.1% Asian, and 6.1% Hispanic. There was a slight increase in the proportion of the Hispanic trial participants from July 2013 onwards. At the same period though the proportion of Black participants decreased slightly.
In September 2020 the U.S. FDA’s Center for Drug Evaluation and Research (CDER), released a report with the title: “Global Participation in Clinical Trials: 2015-2019.” The report summarises CDER’s Drug Trials Snapshot program by illustrating the demographic groups represented in the clinical trials for new drug approvals from 2015-2019. According to the report, of the 102.596 U.S. trial participants of the period 2015-2019, 56% were women, 21% were 65 years and older and only 16% were Black or African American.
Barriers to diverse participation
The reasons behind these apparent disparities in trial subjects’ race are many. The main barrier though seems to be the equity in access to healthcare. Participation in a clinical trial requires that first of all, you have an insurance plan that can cover the large healthcare costs needed in order to have access to all available treatments, including the costs for traveling to the clinical sites or having a caregiver take time off work. Other barriers may include language or cultural differences, religion, or lack of awareness and knowledge about what it actually means to participate in a clinical trial.
Efforts to eliminate the disparities
Various efforts have been made to enhance the diversity of the clinical trials. In the US, the FDA’s Office of Minority Health and Health Equity has a number of initiatives, including educational material, public service announcements, and social media programs in English and Spanish, with the aim to raise awareness among patients, doctors, and company sponsors. It also introduced draft guidance which “provides the agency’s current thinking on steps to broaden eligibility criteria in clinical trials through inclusive trial practices, trial designs, and methodological approaches”.
Pharma’s role
But what can pharma companies do in order to decrease these disparities? Here are a few suggestions:
- Select trial sites that will enable the inclusion of diverse patient populations. Trial sites that are located in big cities or close to them are suggested, as they could enable the participation of a broader part of the population.
- Frequent visits to a trial site might be a burden for some people and a major factor that could limit participation. Consider alternative methods for the participants to “attend” the trial when needed (electronic communications- such as phone, email, social media- or digital tools that could provide the investigators with real-time data, flexible study programs, etc.)
- Enroll patients who represent the clinically relevant population with regard to sex, age, race, and ethnicity.
- Collaborate with patient advocacy groups within the trial site area. Early engagement with patient organisations could provide valuable insights for a future study, taking into account the patient perspective, and at the same time build a trusted relationship that could broaden community participation.
- Train the company employees on how to outreach specific populations in order to increase awareness and knowledge around clinical studies.
- Connect with subject matter experts and learn from their experience.
- Keep track of the company’s progress of minority engagement and participation.
- Include routinely discussions around this matter on the company’s weekly agenda.
Moving forward
As covid-19 proved in a massive way, there is a great difference in the impact that a certain disease has on the different segments of the population. Some people might not be affected at all, while others might die, infected by exactly the same virus strain.
A diverse clinical population would help researchers produce more accurate results and provide better treatments. Therefore, it is very important that the clinical trial participants represent the population that is going to actually use the medical product. But apart from the scientific and medical impact that these disparities have on healthcare, lack of diversity in clinical trials is, primarily, a moral issue, and it should be in everyone’s interest to promote access and equity in every part of society.
#diversity #clinicaltrials #clinicalstudies #accesstocare #inclusion #healthcare #healthcaredisparities
Sources
https://www.fda.gov/media/143592/download?utm_medium=email&utm_source=govdelivery
https://jamanetwork.com/journals/jamaoncology/fullarticle/2748395