By Karen Ledesma
Diversity and inclusion are imperative pieces when conducting clinical trials, but they continue to fall short at representing the diverse population. Factors such as differences in age, ethnicity, race, and gender may yield distinctive results in people when responding to the same treatment. When including a diverse population, one will be able to see where results may or may not be effective or safe in certain populations. Inclusion of all these groups is paramount as it provides findings that are more generalizable to the whole population. When all diverse populations are included, it will validate that the drug or medical device is efficacious and safe for all and not just for one population.
Specific groups have been underrepresented for many years in clinical trials, especially people of color. For instance, in an article from JAMA oncology, it was found that only 145 trials of 230 reported any information about the participants' race for FDA oncology drug approvals. According to the same article, Whites represented 76.3%, Asians 18.3%, Blacks 3.1%, and Hispanics 6.1% of trial participants and from 2013 the proportion for each race enrolled changed minimally with the Black participants enrollment decreasing slightly as Hispanics increased by a little over one percent. Compared with their proportion of US cancer incidence, Blacks and Hispanics continue to be underrepresented, while Asians are overrepresented, and Whites are represented correctly.
According to an article posted in PharmaVoice, African Americans account for 13% of the US population, but only make up 5% of clinical trial participants and Hispanics account for 16% of the US population, but only make up 1% of clinical trial participants. On the other hand, Caucasians account for 67% of the population and 83% of research participants. Additionally, PharmaVoice mentioned Census Bureau’s prediction that racial and ethnic minority populations in the United Stated will grow to become half of the U.S population in three decades, by 2050. As a result of the increase in the minority populations, it is expected that clinical trial studies will begin to include participants of all races to better represent the population at large.
Strategies sponsors are considering to increase representation
Although the importance of diversity and inclusion has been known to sponsors, not much has been done to increase the representation of minorities. There are many approaches sponsors can take to guarantee that the study population better reflects the entire population who will be administered the new treatment.
Dr. Jonathan Loree, a Medical Oncologist and Assistant Professor at the University of British Columbia, told Medical New Today (MNT) that “[physicians] need to listen to [their] patients and understand how they feel about research and the barriers each patient faces to participating in clinical studies.” Communication between physicians and patients plays a crucial component in clinical studies. it will help physicians better understand their patients as well as their concerns and challenges they face.
Another important aspect is including the patient's voice during the planning of clinical trials. Dr. Kanwal Raghav, an Associate Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, communicated to MNT that patients themselves can influence the demographics of future trials by “regularly inquiring about their possibilities of participating in clinical trials.” Furthermore, he mentioned that researchers should “educate patients on how researchers design and run trials and involve them to help develop strategies to reach more diverse populations.” Additionally, Rear Admiral, Richardae Araojo stated “identifying site locations where there are more racial and ethnic minorities and diverse study team staff are also efforts that support recruiting minority populations.” A site having diverse staff, researchers, investigators, and sponsors can most certainly increase the amount of minority participants by virtue of availability of studies in these areas.
The Food and Drug Administration has been working on practices that will lead clinical trials to better reflect the whole population. The FDA has been “hosting public meetings, developing tools, and issuing guidance documents” said RADM Araojo. Araojo also indicated that the FDA’s Office of Minority Health and Health Equity is working towards more cultural and linguistic strategies and resources. These include campaigns, educational material, public service announcements, and social media programs to raise awareness on the need for minority groups to participate in clinical trials in both English and Spanish.
What sponsors can do to increase representation
Sponsors play an enormous role in helping to increase diversity in clinical trials. Dr. Coleman Obasaju, a Global Leader for Clinical Diversity at Eli Lilly and Company, wrote in PharmaVoice. A forum called diverse site centers of excellence was created and serves as a means for them to “reach out to stakeholders to have productive discussions around tactics that can be scaled up to have a bigger impact in the country.” This forum will help them collaborate with other pharma companies and groups as an effort to increase diversity in clinical trials.
In 2016, Biogen launched MS PATHS (Multiple Sclerosis Partners Advancing Technology and Health Solutions), a network of healthcare practitioners and neurologists to gather data from 17,000 patients from more than 50,000 patient visits to allow a 360-degree disease assessment. Recently, Biogen did a study with Tufts Center for the Study of Drug Development to investigate ways to help improve clinical trials and how to remove barriers that potential participants face in joining. Similar to the actions of the FDA, Biogen is also forming a Community Advisory Board consisting of African Americans and Latino members to help develop educational materials for the minority population. Additionally, Biogen is creating a diversity and cultural sensitivity training to help clinical trials expand the inclusion of diverse populations.
Another solution to increase diversity, as Hopkins Biotech Network suggests, is to implement “mobile health (mHealth) applications and flexible trial design to promote trial diversity.” Hopkins says this will reduce the frequency of study visits and make patients more amenable to financial reimbursement for participation. Sponsors could also use the app to advertise the description of the study and provide a secure link to enroll in the study. This app may help raise awareness and reach more diverse populations, therefore, ensuring that participants in clinical trials do in fact represent the whole population. Using technology and software systems analytics, as LINEA System is improving on, will pave the way to launch clinical trials efficiently and accurately representing a more diverse population to support research and development of a new drug.