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When Is A Company Shading the Truth About Its Clinical Trials?
I wanted to point out this fine piece by Adam Feuerstein, “How to Tell When a Drug Company Fibs About Clinical Trial Results”. The points he makes apply especially to small companies trying to stay afloat, but they can show up anywhere.
You need to look at when the trial started (and thus how long it took, relative to how long it should have taken), what the stated endpoints were before the trial, the time points at which these benefits (real and otherwise) occurred, and how the current trial results match up with previous ones. One general rule that I have, which Feuerstein also notes, is that when a company makes a big deal out of their investigational drug being safe/well-tolerated in a Phase II trial, that’s a red flag. It’s certainly a good thing that the drug was tolerated, but finding that out is not the point of Phase II.
But as the article details, clinical endpoints are where a lot of the hand-waving goes on. If a trial is designed well at all, it’s run to look for the most clinically relevant signs that the investigators can think up – the ones that are going to make the patients, the physicians, the regulatory agencies, and the investors pay attention. And if a trial concludes and the company starts talking instead about various other benefits and trends that were seen in the data, while not making as big a deal out of the previously stated endpoints, well. . .there’s a reason for that. It’s not a good reason, and may not even be a very honorable one, but believe it, there is a reason.
Derek Lowe is a medicinal chemist with over 20 years experience in the drug industry. He blogs daily on science and drug discovery at In The Pipeline
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