Unbiased Analysis of Today's Healthcare Issues

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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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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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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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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