Why we need to register and report the results of all clinical trials

[AussieNeil]

schwit1 writes in Slashdot: "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. From Nature: nature.com/news/registered-... "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. 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."

Slashdot: science.slashdot.org/story/...

The book "Emperor of all Maladies" amazon.com/The-Emperor-All-... which does a great job of explaining how we have improved our knowledge of cancer and means of treating it, includes a very telling example of how very important multicenter Stage III randomised controlled trials are in determining whether new treatments are effective. The treatment concerned was high-dose chemotherapy and bone marrow transplant (HDC/BMT), a treatment regimen for metastatic breast cancer.

Here's a summary of what happened:

en.wikipedia.org/wiki/High-...

"From its birth in the 1980s to its denouncement in the late 1990s, HDC/BMT transformed clinical practice, legislation on healthcare insurance coverage, public health policy and drove a two-decade long period of entrepreneurial oncology. It also gave rise to one of the most serious cases of research misconduct of the 20th century."

London based AllTrials has been campaigning for "All Trials Registered | All Results Reported" and states that "Almost half of all the clinical trials ever conducted have never been reported.

Their story of the campaign to find the missing trials and data — and to fix medicine is told here:

alltrials.net/news/the-stor...

Neil

Photo: A flowering canola crop under the Belt of Venus. The Belt of Venus or Venus's Girdle (also known as the anti-twilight arch) is the pink band in the sky above the shadow of the Earth – in the east after sunset, or west before dawn.

[jangreen]

Hi since I was a patient on a trial, which to date has never published any results, this is of particular interest to me. Sense tells me that by now four years later they must have something to say. This type of negative openness really does deter people from going on these trials in the first place. The trial was the Admire trial. Best wishes.