A report by NPR, based on federal clinical trials data, showed that the COVID-19 pandemic has forced hundreds of clinical trials to stall. Academic medical centers, hospitals and community research centers have all seen some clinical trials stopped or paused. While some research institutions are slowly re-opening their campuses, many investigators and their staff are still working remotely from home, at least part time. This has had a significant impact on both industry sponsored and investigator initiated clinical trials. Some investigators, residents and fellows needing to do their scholarly research, are keen to initiate studies, particularly those that may not require participants to make in person visits to medical facilities. The FDA has issued guidance on conducting clinical trials during the pandemic....

By Kathy Rembisz   Biomedical Research Alliance of New York (BRANY) released a new research protocol template specifically designed to address the unique needs of social-behavioral-educational researchers. This launch comes as part of Protocol Builder, a secure, cloud-based protocol writing application. This special template provides a guided, step-by- step protocol-writing process for investigators who specialize in psychology, nursing, educa- tion and other disciplines that are focused on behavioral and social functioning. “Social and behavioral research is distinct from biomedical research,” said Jeffrey Cohen, Ph.D., a principal with HRP Consulting Group, a division of BRANY. “The process of writing a protocol can be more subtle than an interventional drug study, for example,” said Cohen. He explained that while biomedical researchers are generally accustomed to preparing, sub- mitting and following...

Most medical schools, as part of the graduate medical curriculum, require residents to conduct at least one research project. These projects are designed to give clinicians early in their career an opportunity to manage a project, understand the importance of well-designed clinical research and to improve their communication skills. This may be the first time a resident goes through the entire process of writing a clinical research protocol that must undergo the rigorous review by their superiors and the IRB. Some institutions provide the resident with a mentor, or preceptor. But in some cases, the resident must rely on other sources for assistance, such as fellows or the medical librarian. A successful residency research project starts with a strong, well-developed protocol....

The NIH and the FDA last week announced a draft clinical trial protocol template to help clinical investigators save time, and to encourage more investigators to engage in research. BRANY’s own research indicates that clinical researchers find writing protocols to be both time-consuming and difficult. Any tool that makes it more efficient for researchers and improves the quality of research protocols for institutions will benefit research overall. Over half of researchers have access to templates from their institutions. Often they can download them from Web sites. These can vary from one institutions to the next. A standardized “common protocol template” approach, such as the FDA and NIH are proposing, can go a long way to alleviating delays and improve protocol design. Additionally,...