Very interesting article on the trade-off:
However, I am not sure it covers all the costs of a more lengthy process that tries to ensure data integrity. Faster, cheaper processes leads to faster/cheaper drugs, and ultimately more effective drugs. The cost in delaying the process (more data integrity) lies in
I think this article does not cover all the costs of a more lengthy process that tries to ensure data integrity. Faster, cheaper processes leads to faster/cheaper drugs, and ultimately more effective drugs. The cost in delaying the process (more data integrity) lies in
1. the patients' lives endangered,
2. more difficult recruiting of patients into randomized clinical trials. Patients who put their lives on the line to go through the blinded trials. When they hear the preliminary data that's highly promising but may be just a little short, they need to make the choice of dropping out of clinical trials if they are in the control arm vs staying in the control arm, and die to make the OS (overall survival) data true. That is difficult choice for patients and physicians, and difficult for any future double blind clinical tials to recruit.
3. in the ultimately higher cost of drugs.
Note how almost all the drugs that had early terminated drug trial end up being highly effective and lifesaving. If a couple of drugs later turned out to be less effective than originally thought, it's not a big deal. The statistically significance standard for treatment for end-stage cancer with no other options should take into account the benefit for patients, and be different than the standard for treating something less deadly.
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