Guarding the gates of the research integrity underworld: the medical writer as cerberus - Art Gertel
3:30 PM - 3:55 PM
Research integrity has to survive a long and winding road, from concept, to proof-of-principle, to preclinical research, through the phases of clinical research, dissemination of information through publications, scientific conference symposia and poster sessions, public postings, and press releases. If we examine the points on the spectrum where integrity is most vulnerable, there are opportunities for medical writers/communicators to serve as protectors of this integrity through their partnership with their research and development colleagues. Often responsible for the “final product”, whether it be a study protocol, a clinical study report, a dossier filed to a regulatory authority in support of commercial approval, or a manuscript for publication in a peer-reviewed medical journal, the medical writer has multiple touch-points during which they can influence the protection of data and interpretive integrity. The medical writer is a hybrid, whose effectiveness relies on a depth of knowledge about science and medicine, regulatory affairs, and the skill to distill complex information into cogent, accurate documents that comply with regulatory standards and formats. Thus, the analogy to the three-headed dog of Greek mythology, charged with guarding the gates of Hades.
We will examine how the medical writer/communicator can enhance the protections of research integrity, thanks to their unique roles in the research and development process.