Preregistration of clinical trials causes medicines to stop working!

Screenshot 2016-02-29 21.25.38

Something must be done to combat this public health hazard. In 2000, the National Heart Lung, and Blood Institute (NHLBI) began requiring that researchers publicly register their research analysis plan before starting their clinical trials. From a new PLOS paper:

We identified all large NHLBI supported RCTs between 1970 and 2012 evaluating drugs or dietary supplements for the treatment or prevention of cardiovascular disease.

17 of 30 studies (57%) published prior to 2000 showed a significant benefit of intervention on the primary outcome in comparison to only 2 among the 25 (8%) trials published after 2000 (χ2=12.2,df= 1, p=0.0005). There has been no change in the proportion of trials that compared treatment to placebo versus active comparator. Industry co-sponsorship was unrelated to the probability of reporting a significant benefit. Pre-registration in clinical trials.gov was strongly associated with the trend toward null findings.

Hat tip @rlmcelreath.

139 Responses

  1. If pre-registration had been required in 1897 we would have never discovered penicillin.

  2. For those who don’t click through to the article: note that there is a “harm” outlier in 1991 omitted from the figure reproduced here.