Unbiased Analysis of Today's Healthcare Issues

Archive for the 'Clinical Trials' Category

Too many trials, not enough patients

As research in new cancer treatments has grown, scientists may have run into a serious roadblock: there many not be enough patients to fill the needed clinical trials.  As the New York Times reports: There are too many experimental cancer drugs in too many clinical trials, and not enough patients to test them on. The logjam […]

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Predicting Real-World Effectiveness of Cancer Therapies Using OS and PFS Clinical Trials Endpoints

Clinical trials for cancer treatments aim to demonstrate whether one treatment is better than another. What is of most interest to patients, providers and payers, however, is which treatment works best in the real-world, not in a randomized controlled trial. Further, clinical trials often use progression free survival to measure treatment outcomes rather than overall […]

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Drug approval and reimbursement when clinical trials use surrogate endpoints

An interesting paper from some of my colleagues at Precision Health Economics: Approval of new drugs is increasingly reliant on “surrogate endpoints,” which correlate with but imperfectly predict clinical benefits. Proponents argue surrogate endpoints allow for faster approval, but critics charge they provide inadequate evidence. We develop an economic framework that addresses the value of […]

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China fabricates clinical trial data?

Academic integrity is one of the bedrocks upon which research is founded.  With that said, it is with great concern that I came across an article that stated that 80% of Chinese clinical trials data is fabricated.  Science Alert reports: The review looked at data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass […]

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Efficacy vs. Effectiveness vs. Efficiency

Efficacy describes the technical relationship between the technology and its effects (whether it actually works), whereas effectiveness concerns the extent to which application of an efficacious technology brings about desired effects (changes in diagnoses, altered management plans, improvement in health)…Efficiency is an economic concept which relates efficacy and effectivness to resource use.  Assessment of efficiency is […]

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Should pregnant women be included in clinical trials

Your knee-jerk reaction (and mine) is No!  However, an interesting article from Mosiac makes the case that the argument is not clean cut. Because it has long been considered unethical to include expectant mothers in clinical trials, scientists simply don’t know whether many common medicines are safe for pregnant women. Of the more than 600 […]

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Personalized medicine is the future. What is personalized medicine?

An concise article from Sean Khozin and Gideon Blumenthal (2015) try to explain. “Personalized (or precision) medicine has been broadly described as the administration of the right therapy to the right patient at the right dose and intensity.”  However, this is a fairly broad definition.  Some more concrete examples of personalized medicine include: Modern concepts in […]

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The Placebo Blocker

Courtesy of xkcd.

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How the FDA evaluates Cancer Drugs

The Food and Drug Administration (FDA) reviews and approves all drugs. But what criteria does the FDA use to evaluate new drugs? Namely that they are effective (i.e., improve health outcomes) and safe (i.e., have limited adverse health events). In a 2007 guidance document from the FDA’s Center for Drug Evaluation and Research (CDER) and […]

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