Tag Archives: clinical trials

Requiring scientists to document their methods caused positive results in medical trials to plunge

The uncertainty of science: The requirement that medical researchers register in detail the methods they intend to use in their clinical trials, both to record their data as well as document their outcomes, caused a significant drop in trials producing positive results.

A 1997 US law mandated the registry’s creation, requiring researchers from 2000 to record their trial methods and outcome measures before collecting data. The study found that in a sample of 55 large trials testing heart-disease treatments, 57% of those published before 2000 reported positive effects from the treatments. But that figure plunged to just 8% in studies that were conducted after 2000. Study author Veronica Irvin, a health scientist at Oregon State University in Corvallis, says this suggests that registering clinical studies is leading to more rigorous research. Writing on his NeuroLogica Blog, neurologist Steven Novella of Yale University in New Haven, Connecticut, called the study “encouraging” but also “a bit frightening” because it casts doubt on previous positive results.

In other words, before they were required to document their methods, research into new drugs or treatments would prove the success of those drugs or treatment more than half the time. Once they had to document their research methods, however, the drugs or treatments being tested almost never worked.

The article also reveals a failure of the medical research community to confirm their earlier positive results:

Following up on these positive-result studies would be interesting, says Brian Nosek, a psychologist at the University of Virginia in Charlottesville and the executive director of the Center for Open Science, who shared the study results on Twitter in a post that has been retweeted nearly 600 times. He said in an interview: “Have they all held up in subsequent research, or are they showing signs of low reproducibility?”

Well duh! It appears the medical research field has forgotten this basic tenet of science: A result has to be proven by a second independent study before you can take it seriously. Instead, they would do one study, get the results they wanted, and then declare success.

The lack of success once others could see their methods suggests strongly that much of the earlier research was simply junk, not to be taken seriously.