The progress of new drugs from clinic to market faces numerous challenges that organizations across the industry work tirelessly to address. As an EDC company, Medrio, for example, strives to eliminate inefficiencies in data management that can hinder clinical trials. In this post, we thought we’d take a sample of some of the other challenges facing researchers today. Why are these challenges significant? What are industry players doing to address them?
Minority participation in clinical research
Patient recruitment in general is a notorious challenge in clinical research, but the recruitment of racial and ethnic minorities has consistently been a particular source of frustration. In addition to the lack of awareness of clinical research that creates problems for general recruitment, certain minority populations carry a long history of reservations about clinical research that creates a reluctance to participate. Currently, only about 1 percent of Hispanics in the U.S. participate in clinical research, a troubling statistic in light of the growth of this demographic group, which now comprises about 17 percent of the U.S. population, in recent years.1 Some argue that efforts to address the problem haven’t gone far enough: of 10,000 clinical trials funded by the National Institutes of Health in 2013, only 150 – or less than 2 percent – focused on recruiting a particular ethnic group.2
More recently, greater efforts have been made. Back in January, the FDA declared 2016 the “Year of Diversity” for clinical trials. In this spirit, they have partnered with various groups to increase awareness of clinical trials among minority populations, and launched efforts to maximize the patient experience for these groups. There have also been efforts on the local level, publicized in the news media, to engage specific minority populations for clinical trials. Success for these campaigns would be an encouraging step toward understanding the differences in how different treatments affect different demographics.
Working to improve success rates in Alzheimer’s research
A notoriously low 5 to 10 percent of drugs make it all the way through the phases of clinical research to FDA approval. Alzheimer’s drugs have had a particularly hard time in recent years: between 2002 and 2012, less than one percent of Alzheimer’s trials were successful. For some perspective, cancer trials succeeded at a rate of almost 20 percent during the same period.3 Given the severity of the disease, as well as its projected increase in prevalence as the Baby Boom generation ages, these statistics have caused no small degree of stress in the clinical research industry.
They have also, however, spurred action. A $122 million initiative from the Obama administration in 2014 aimed, in part, to increase Alzheimer’s research. Across the pond, the Medical Research Council in the U.K. recently approved an $85.5 million (converted from the British Pound) study to seek out ways to diagnose the disease in its early stages, when the chances of a treatment being effective are highest. This strategy takes aim at what is widely viewed as a fundamental barrier to success in Alzheimer’s trials: currently, the disease is difficult to detect until its advanced stages, meaning that most trial patients are likely past the period in which their treatments have a strong chance of being effective.4
Of course, these are only two of the many challenges that any industry as robust as clinical research is sure to face. But industry players hope that through funding, outreach, technology, and other efforts, clinical research will continue to learn from its mistakes, find new efficiencies, and, ultimately, bring life-saving drugs to market faster than ever before.
1 The Importance of Latinos in Clinical Trials; National Hispanic Council on Aging; 6 October 2016
2 Dallas, Mary Elizabeth; Still Too Few Minority Participants in U.S. Clinical Trials, Study Finds; Health Day; 21 March, 2014
3 Bushak, Lecia; 99% Of Alzheimer’s Drug Trials In The Past Decade Have Failed, And There’s An ‘Urgent’ Need To Improve Therapies; Medical Daily; 5 July 2014
4 New £6.9 million trial to identify patients with early Alzheimer’s begins in UK; Belfast Telegraph; 22 August 2016