3 ms·
My assumption is that most unpublished trials were "no effect". Be a drug company. Develop a "drug" that is really a placebo (has no effect). Do 10 trials. 8 a
by tomp 7y ago
My assumption is that most unpublished trials were "no effect".
Be a drug company. Develop a "drug" that is really a placebo (has no effect). Do 10 trials. 8 are "no effect", 1 is positive (by chance), 1 is negative (by cance). Publish the positive drug. Market the drug as having positive effect. Sell the drug, make billions. It would take decades for enough other research (mostly "no effect") to accumulate before it becomes obvious that your drug actually has no effect.
- andrewla 7y agoThat’s the whole point of preregistration. The nine unpublished trials can be assumed to be negative, or at least neutral, and were aware that they were done because of preregistration. Therefore regulators have the ability to reject the notion of the effectiveness because so few of the studies reported positive outcomes. In addition, any cancelled studies now taint the authors and sponsors with a (small) amount of suspicion that they are refusing to publish non-positive effects which, cumulatively, will cause their results to be further discounted. That will hopefully provide a strong incentive to publish neutral and negative results.
- jdietrich 7y agoA drug that genuinely has no effect is actually pretty good; most drugs have some sort of risk and many are seriously dangerous. Rofecoxib is believed to have caused around 100,000 heart attacks and 30,000 deaths. Market approval for rofecoxib was based on misleading data and its withdrawal from the market was substantially delayed by misleading data. https://en.wikipedia.org/wiki/Rofecoxib https://en.wikipedia.org/wiki/Rofecoxib