Clinical Trials Confusing—Even to Doctors

Most physicians and many specialists have limited understanding of clinical trial data and research findings presented in prescription drug promotional materials for professional audiences, FDA analysts report. In a study involving interviews with primary care physicians and endocrinologists across the U.S., researchers found that many doctors could not correctly define “randomized controlled trial,” and that majorities did not fully understand terms such as “re-randomization” and “non-inferiority randomized controlled trial.” The docs fared even worse in trying to define “modified intent-to-treat,” “adjusted mean” or “last observation carried forward,” according to a study conducted by FDA’s Office of Prescription Drug Promotion (OPDP) as part of the agency’s effort to better understand the impact of drug advertising and promotional materials on professional audiences.

Although the study queried only a small number of physicians, the results indicate that these professionals have a low-to-moderate familiarity with research concepts used in promotional materials such as sales aides, reported OPDP analyst Helen Sullivan at the recent advertising and promotion conference sponsored by the Food and Drug Law Institute (FDLI) in Washington, D.C.  Sullivan and colleagues hope to follow up with further research on how clinical trial data presented by marketers affect physicians’ attitudes and decision-making.

The larger OPDP research program aims to explore and improve how consumers and prescribers understand risk and benefit information in promotional messages. Another research project on comparative price information in DTC and professional print ads may help FDA evaluate key drug marketing policies, noted OPDP research team lead Kathryn Aikin. This project indicates that most consumers and physicians fail to notice or understand disclosures about the inadequacies of drug price information in such promotional pieces, even when such caveats are prominently displayed.

One key area where FDA research may help inform regulation of DTC and professional advertising involves whether consumers may retain more risk information when such messages are more targeted. FDA announced in August that it is examining its policies for how drugmakers present risk information in TV commercials and whether limiting disclosures to severe, serious or actionable side effects may be more effective than the current long lists of potential side effects [see https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm572267.htm ]. FDA commissioner Scott Gottlieb stated that FDA’s goal is to make sure that consumers who view broadcast ads “walk away properly informed of the key potential tradeoffs of using a prescription medicine.”