PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s draft guidance "Considerations for Inclusion of Adolescent Patients in Adult Oncology Clinical Trials," which was published in the Federal Register on June 4, 2018.
We applaud the draft guidance’s recommendation that adolescent patients with cancer be enrolled in disease- and target- appropriate adult oncology research, provided certain conditions are met. Presently, adolescents with cancer need to [...] Read more
PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s draft guidance "Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials," which was published in the Federal Register on April 9, 2018. PRIM&R suggests a few areas for further clarification, but generally applauds the agency for taking this important step to fill current regulatory gaps around the inclusion of pregnant women in FDA-regulated clinical trials and ultimately believes that the draft guidance will be of great benefit to relevant stakeholders, including industry, IRBs, and research subjects. Read more
Just a year or two ago most people didn’t even know what the term “wearable” meant. Today, they are one of the largest growing technology segments, and are predicted to continue growing exponentially. As this technology continues to improve, more uses are being invented and implemented, including in the realm of health care and clinical trial research. Read more
Expanded access, which is treatment access to experimental drugs (also referred to as "compassionate use" or "pre-approval access"), has generated increasing interest and debate over the last several years. Currently, US federal regulations allow manufacturers to provide Investigational New Drugs (INDs) to patients with serious diseases or conditions who have exhausted approved therapeutic options, and cannot participate in a clinical trial. As key players in the pre-approval access process, IRBs must review and approve expanded access protocols in accordance with FDA guidelines. Moreover, the new “Right to Try” laws currently taking effect on both the federal and state levels make it especially crucial that IRB members stay informed about ongoing developments and potentially thorny ethical issues. Read more
This post draws on information I learned from two presentations. The first, “SBER in the Era of the Revised Common Rule: An Overview of the Most Relevant Regulatory Changes” by Yvonne Lau, MBBS, MBHL, PhD (Director, Division of Education and Development, Office for Human Research Protections), was given at PRIM&R’s 2017 AER conference. The second, “Clinical Trials in the SBER Context” by Melissa W. Riddle, PhD (Chief, Behavioral and Social Sciences Research Branch, National Institute of Dental and Craniofacial Research) and Cindy S. Shindledecker, CIP (Director, Health Sciences and Behavioral Sciences Institutional Review Board, University of Michigan), was given at PRIM&R’s 2017 SBER conference. (Dr. Riddle was absent, but her colleague Wendy Webber, ND, PhD, MPH (Acting Deputy Director, National Center for Complementary and Integrative Health) was able to do an impromptu presentation on behalf of NIH.) Read more