This month’s Research Ethics Roundup covers the reportage of the PHS Study of Untreated Syphilis, considering the ethics of research on insects, multiple perspectives on patient engagement in clinical trials, and the challenges of developing drugs for ultrarare diseases. Read more
This month’s Research Ethics Roundup covers enduring "publish or perish" incentives, a new grant program to increase the number of funded Black researchers, a beagle facility's impending closure, and lagging trial representation for older cancer patients. Read more
The clinical trial workforce's incredible response to the COVID-19 pandemic has generated some of the most positive media coverage and public acclaim the drug and device research and development industry has ever seen. "We need to harness that public awareness," says Elisa Hurley, PhD, executive director of PRIM&R. Read more
PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s draft guidance "Considerations for Inclusion of Adolescent Patients in Adult Oncology Clinical Trials," which was published in the Federal Register on June 4, 2018.
We applaud the draft guidance’s recommendation that adolescent patients with cancer be enrolled in disease- and target- appropriate adult oncology research, provided certain conditions are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PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s draft guidance "Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials," which was published in the Federal Register on April 9, 2018.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gaps around the inclusion of pregnant women in FDA-regulated clinical trials and ultimately believes that the draft guidance will be of great benefit to relevant stakeholders, including industry, IRBs, and research subjects.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
