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Physician’s Perspective in Using Clinical Trials Data in Patient Care
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[Thursday, May 21, 2020]

Physicians are often coaxed by their patients to try the latest product approved by FDA or in the news. However, before a treatment decision is made, one must understand the clinical data that was used to support the market approval. While placebo-controlled studies may be the gold standard for the FDA approval of a given product, those studies provide little information about the comparison of the new treatment to available therapies. In a perspective published in the Journal of American Medical Association, a group of physicians suggest a few ways, doctors can evaluate if reasonable justification exists to switch to a new treatment.  The first criteria is independent publications evaluating positive outcomes, meaning a significant difference to neutral one where there is no statistical difference between the new and the previous treatment. The next step is review of the totality of evidence in terms of the effect size and incidence rates. There could be cases where non-statistical differences in the primary outcomes are balanced by other evidence that justify change in practice. The authors contend that doctors should build “a broader understanding of the overall likelihood that one treatment represents a better option for patients than the other” by reviewing the “trial methodology, other evidence, comparative cost-effectiveness, invasiveness, and labor-intensiveness” but this may not be practical for most busy physicians. But this is useful approach for companies looking to promote wider use of their newly approved product. Product presentations on the above lines could convince more physicians to switch the treatment for their patients. In addition, it may help developers of new products to present side-by-side comparison to their product to the available therapies via independent peer reviewed publications. It is important to evaluate physicians’ perspectives as much it is to consider patients’.

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