On August 5, 2021, PRIM&R hosted a webinar entitled IRB Review of Expanded Access Protocols that Collect Real World Data: Considerations and Guidance. During this webinar, speakers discussed ethical and analytical considerations when collecting real world data from Expanded Access. Today, they provide further information and answer follow-up questions. Read more
In 2010, a little-known research institute, the Patient Centered Outcomes Research Institute (PCORI), began funding hundreds of clinical studies with the aim of increasing the value of medical innovation. These studies included patients and family members in every step of the research process. This approach, called patient-centered outcomes research, has become a novel tool for conducting health care investigations; but, it raises ethical issues, which have largely been pushed to the background. Read more
For this month's question, you are a principal investigator in a very promising Phase 3 pancreatic cancer study. The sponsor has just informed you that you can enroll only one more patient before enrollment closes. Enrolling in this study might save your patient’s life. Ten of your patients are eligible for the study. Who do you invite to participate in the study, and how do you decide? Read more
