Avoiding Bias and Ensuring Content Validity in Accredited Continuing Education: What Do the Latest ACCME Standards Mean for Medical Writers?

Abstract

Some continuing medical education (CME) activities are developed using financial support from entities such as pharmaceutical companies that may have a commercial interest in the therapeutic area being discussed. Accordingly, standards intended to shield CME from industry bias have been in place for decades. The latest iteration of these standards from the Accreditation Council for Continuing Medical Education (ACCME) has a special significance to medical writers due to their emphasis on clinical content validity. Once a separate entity, the content validity requirement is now incorporated into the ACCME standards. In fact, it is positioned as the number 1 standard, emphasizing its importance. It should be relatively straightforward for writers to support the goals of the guidance—that is, to provide relevant and scientifically accurate content that is free from industry manipulation or influence. However, the standards as published are not prescriptive in how to achieve these goals, leaving writers to ponder exactly what it means to be “fair and balanced.” This article provides background on the ACCME standards with a special emphasis on their relevance to CME writers, describes helpful downloadable resources for writers, discusses some scenarios that medical writers may encounter, and provides practical advice in interpreting and applying the current standards when developing content for CME activities.