This week’s Research Ethics Roundup looks at why the elderly continue to be underrepresented in clinical research, how a massive government study is working on community engagement efforts, the Food and Drug Administration (FDA)’s plan for new patient-focused drug development guidance, and a European Union committee’s opinion that nonhuman primate research should continue in its member countries.
Seniors Miss Out On Clinical Trials
In this Kaiser Health News article, Judith Graham finds that enrollment of older adults in clinical research, including oncology and Alzheimers trials, continues to be poor despite the disproportionate impact such diseases have on that age cohort. Enrollment is low in part because seniors often have other pre-existing conditions that preclude enrollment; however, at the same time, experts note that without adequate research on how seniors respond to certain treatments, physicians are unable to practice evidence-based medicine in this population.
What Ethical Issues Does the Precision Medicine Initiative Face?
In this Healthcare Informatics blog, David Raths reviews the recent remarks by Nancy Kass, the IRB chair of the All of Us Research Program–the largest research study the US government has ever conducted on its own population. According to Kass, the ethical stakes are extremely high and as such, the program is pursuing community engagement efforts to ensure that the government’s work is as transparent as possible and has appointed three of its ten IRB members from community organizations.
$500m Over 9 Years: FDA Details Plan for New ‘Cures’ Funds
Zachary Brennan reports for Regulatory Focus that the FDA recently announced how it will spend the prospective funds allocated to the agency in the 21st Century Cures Act. Plans include issuing more patient-focused drug development guidance on how to better collect input from patients during clinical research, as well as draft guidance on processes for developing methodological approaches to determine what matters most to patients in terms of their treatment and related issues. However, Congress must approve the 21st Century Cures Act funds each year, so it remains to be seen whether the agency will actually receive the funds to follow through with its plans.
Europe to Stay Open for Non-Human Primate Research
In this Applied Clinical Trials article, Peter O’Donnell discusses a European Union advisory committee’s new recommendations that nonhuman primates (NHPs) should continue to be used in European research but that there must be “ethical limits” to NHP use and there is “an urgent need to conduct systematic reviews and meta-analysis of all areas of NHP use” to identify areas where the NHP model is inappropriate. In making their decision, the committee recognized that if Europe were to end research with NHPs, sponsors might instead conduct their studies in countries with lower animal welfare standards.