"Underrepresentation means missed opportunities…that will influence drug efficacy…"
Baltimore, MD (PRWEB) November 24, 2014
Continental Clinical Solutions, LLC (Continental) focuses on recruiting underrepresented patient populations into clinical trials at its mid-Atlantic late-phase research facility, located in Baltimore, Maryland.
“Continental was created with the idea of closing patient disparities in mind. Clinical trials play a fundamental role in medical advances," said Continental's CEO, Saleh Stevens. "From the Tuskegee syphilis experiment to the immortal cell line of Henrietta Lacks, dubious ethical practices and on-going safety concerns have plagued recruitment in the minority segment for clinical trials in the US and abroad." The exclusion of large patient populations from clinical trials adversely impacts scientific advances.
Almost 40% of registered clinical studies occur in the United States, equaling an approximate 66,700 clinical trials. The number of trials in the US increased by almost 16% since 2013, according to ClinicalTrials.gov, a website dedicated to information on clinical studies registered with the FDA. Despite the increase in studies, the percentage of the US population participating in studies has remained stagnant at 6%.
“When you further distill that 6%, you find minorities in late phase studies are terribly underrepresented. Underrepresentation means missed opportunities to address specific genomics and other criteria that will influence drug efficacy in the specific populations, sentencing future generations to inadequate medical remedies," Stevens added.
Though mistrust is a large obstacle in diversity in recruitment, insurance and cost of care continue to play a role in stymying minority recruitment into trials. Many unapproved treatments have been reserved solely for patients who can afford to pay out of pocket for travel and study-related healthcare needs. Those costs can vary from hundreds to tens of thousands of dollars, according to a report commissioned by the Pharmaceutical Researchers and Manufacturers of America. Previously, many insurers excluded healthcare related to certain phases of clinical trials under "experimental" and "investigational" exclusions in their policies. These exclusions, when triggered, not only denied reimbursement of trial-related healthcare costs, but sometimes resulted in policy cancellation—an untenable circumstance for patients already leery of joining studies.
Beginning January 1, 2014, the Affordable Care Act set forth legislative changes impacting some of the cost issues patients face when considering clinical trials. The resulting federal laws ensured that new health insurance plans cover routine care costs for people taking part in clinical trials. Insurers are no longer permitted to drop coverage because of patient participation in a clinical trial. Maryland, among a few other states, has been ahead of the curve with covering significant costs associated with clinical trials, with legislation dating as far back as 1998.
"With the connectivity that social media platforms afford us, it is incumbent upon us to communicate the changing landscape to patient populations who are left either unaware or out of the study pipeline," Stevens concluded as he reiterated Continental’s commitment to reducing disparities in clinical trial patient populations at its Maryland site.
Continental Clinical Solutions, LLC is a multi-therapeutic dedicated research clinic providing turnkey clinical trial sites for community practitioners in all trial phases, bringing diverse patient populations and industry pharmaceutical companies together. Visit Continental Clinical Solutions at http://www.continentalclinical.com.