Drugs

The Effect of Marketing on Clinical Trials Studied

Researchers looking at the effect of marketing on clinical trials say their work raises questions more than answering them and further study is needed. Writing in the online journal Trials, the researchers say that analysis of trial documentation has indicated that some industry-funded trials may be done more for marketing purposes than scientific endeavor. They attempted to define characteristics of drug trials that appear to be influenced by marketing considerations and estimate their prevalence.

Six clinical research experts and medical journal editors agreed that 21% of drug trials published in 2011 in the leading general medical journals had characteristics consistent with the aim of marketing the product. The study report says that use of expert opinion is necessarily subjective and open to bias. In trying to identify a consistent set of marketing trial characteristics, they proposed that such trials were more likely to be explicitly funded by the manufacturer, and to have authors or contributors from the manufacturer involved in or in control of the study design, data analysis, and trial reporting. In addition, suspected marketing trials contained speculation or generalized phrasing that might encourage clinicians to use the intervention outside of the study population.

The authors note many study limitations and say their work “revealed the difficulties of trying to apply a quantitative approach to characterizing something as nebulous as a marketing trial. The main issue raised is whether the current system of designing and publishing intervention trials does serve the best interests of patients and health practitioners. We hope that this research will trigger further debate on trials and remind editors, peer reviewers, and readers of the need to closely scrutinize clinical trials for their design (including recruitment strategies and the role of the product manufacturer in the design, analysis, and reporting of the study) as well as their findings.”

The researchers conclude that while manufacturers have to market their drugs, marketing imperatives should not unduly influence the design of the studies and the clinical question under investigation.

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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