Drugs

Most Clinical Research is Useless: Researcher

Reform is needed so that more clinical research could be useful, according to Stanford University School of Medicine researcher John Ioannidis. Writing in the open access online journal PLOS Medicine, Ioannidis says that clinical research should be useful in that it should make a difference for health and disease outcomes or should be undertaken with that as a reasonable prospect.

He says that features that make clinical research useful include those relating to problem base, context placement, information gain, pragmatism, patient centeredness, value for money, feasibility, and transparency. “Many studies, even in the major general medical journals, do not satisfy these features,” he says, “and very few studies satisfy most or all of them. Most clinical research therefore fails to be useful not because of its findings but because of its design.”

According to the article, the challenges and problems to solve to improve clinical research involve not only researchers but also institutions, funding mechanisms, the industry, journals, and many other stakeholders, including patients and the public. He discusses steps each of those groups can take to improve the situation.

“Overall,” he concludes, “not only are most research findings false, but, furthermore, most of the true findings are not useful. Medical interventions should and can result in huge human benefit. It makes no sense to perform clinical research without ensuring clinical utility. Reform and improvement are overdue.”

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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