FDA Policy/General

Methodological Rigor Info May Help Promotions: OPDP

Researchers in the CDER Office of Prescription Drug Promotion say they found that prominently disclosing information related to the methodological rigor of a study may help healthcare professionals form an accurate perception of the strength of the study and support for any claims that may be in promotional communications. The FDAers report on their research that builds on previous findings related to the impact of methodological rigor by incorporating time pressure and information source as additional factors that may influence prescribing intentions.

Writing in the open source Research in Social and Administrative Pharmacy, the research says that information of varying quality is disseminated in a variety of ways, and doctors and other providers must be able to distinguish studies that are high quality methodologically from those that are lower quality. “Some research suggests physicians may lack the knowledge and skills necessary to understand and correctly interpret research results, which may in turn affect prescribing,” the paper says.

The study explored how manipulations of methodological rigor, source, and time available to read prescription drug information might influence physicians’ perceptions of that information.

In addition to the finding on methodological rigor, the study also found that promotional communications without graphics that appear to be more closely related to study reprints or summaries may be approached and interpreted with less caution by physicians and other healthcare providers than promotional communications that fit the classic expectation of “promotion.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome