May 20th is International Clinical Trials Day where around the globe, communities will be coming together to honor study volunteers and highlight ways in which clinical research improves public health and advances medical treatments.
Clinical Trials Awareness Week is also the best week to recognize the healthcare professionals who strive daily to produce the most effective treatments for patients. In any given year, there are hundreds of thousands of clinical trials being conducted by healthcare professionals with the goal of providing higher quality drugs, medical devices, and clinical practices to patients. From daily household treatments such as aspirin or ibuprofen to complex medical devices, all approved treatments and practices were at some point involved in a clinical trial.
Through hundreds of thousands of clinical trials, 2017 has seen record numbers of approvals for novel drugs, medical devices, and generic drugs—all of which will lead to higher quality medical treatments at lower costs to the healthcare system. The Food and Drug Administration (FDA) is recognizing the need to engage in a more efficient approval process to serve the needs of the population.
Although the process of clinical trials is critical, the people involved in these studies are just as important—if not more. Indeed, it is through these volunteers that research and innovation are possible. It is for this reason that pharmaceutical industries are engaging with healthcare organizations to incorporate patient perspectives throughout all elements of the research and development process. As major stakeholders in research and development, patients and their families can provide crucial information on their conditions.
There is, however, much-needed improvement for appreciating the importance of patient perspectives in clinical trials. Indeed, patients of different backgrounds respond differently to treatments, and such realities should be appreciated in clinical trials. According to the Association of American Medical Colleges, while African-Americans and Hispanic patients jointly represent about 29% of the population, they only represent about 6% of clinical trial participants.(1)
Patients with different genetic makeups react differently to medical treatment, and it is time that healthcare professionals project such complexities into their studies. For example, Angiotensin Converting Enzyme Inhibitors (ACEI), a class of drugs used to treat hypertension, has been shown to be less effective in African-American patients, requiring black patients to seek other effective treatments for hypertension.(2) Another example is a more toxic drug, Warfarin that is used as a blood thinner. Without the correct dosage, Warfarin can be deadly to patients. It was found that a genetic variation exists for about 40% of African-Americans, requiring a lower dose of Warfarin to be both safe and effective.(3)
At CHI, we strive to promote more diversity and inclusion into clinical trials to reflect the complexities of healthcare delivery. For a complex discussion on diversity in clinical trials, CHI is designing our 8th Diversity, Inclusion, & Health Equity Symposium, a leading annual, collaborative event focusing on health equity and health disparities in the U.S. The symposium brings together leading healthcare professionals, executives, physicians, patient groups, patients, researchers, academics, clinical trial professionals, and diversity and inclusion advocates to discuss health equity in the life sciences and the health sectors. Attendees will learn practical solutions, share perspectives, and meet new industry and marketplace colleagues. Please visit chisite.org/dilss for more info or to register.
References Califf, R (2016). 2016: The year of diversity in clinical trials. Food and Drug Administration: Blog. Retrieved from https://blogs.fda.gov/fdavoice/index.php/2016/01/2016-the-year-of-diversity-in-clinical-trials/
Levine, D, and Greenberg, R (2016). Minorities needed in clinical trials to make research relevant to all. Association of American Medical Colleges. Retrieved from https://news.aamc.org/diversity/article/more-minorities-needed-clinical-trials-research/ Page, M (2014). The JNC 8 hypertension guidelines: an in-depth guide. American Journal of Managed Care. Retrieved from http://www.ajmc.com/journals/evidence-based-diabetes-management/2014/january-2014/the-jnc-8-hypertension-guidelines-an-in-depth-guide  Perera, M, Cavallari, L, Limdi, N, Gamazon, E, Konkashbaev, A, Daneshjou, R, Plazhinikov, A, Crawford, D, Wang, J, Liu, N, Tatonetti, N, Bourgeois, S, Takashashi, H, Bradford, Y, Burkley, B, Desnick, R, Halperin, J, Khalifa, S, Langaee, T, Lubitz, S (2013). Genetic variants associated with warfarin dose in African-American individuals: a genome-wide association study. The Lancet, 382(9894), 790-769.