Cochrane Collaboration joins AllTrials

That’s right, earlier today, the Cochrane Collaboration announced that it has “formalized its commitment to the AllTrials: All Trials Registered | All Results Reported initiative.”

This is great news, but I’m honestly a bit surprised that it took them so long. The Cochrane Collaboration is currently celebrating its 20th anniversary as a leader in the movement for evidence-based medicine. It was started as an answer to Archie Cochrane’s (a British epidemiologist) calls to maintain up-to-date, systematic reviews of randomized controlled trials (RCTs) of medical interventions. Cochrane Reviews, as they are called, are the gold standard in systematic reviews in the medical literature. This is because they use rigorous, standardized methods, published in the Cochrane Handbook, to ensure that the reviews are consistent, transparent, comprehensive, and as objective as possible. They are also accessible for free in over 100 low and middle-income countries (LMICs) (too bad they’re not open access).

When I first heard of Cochrane a few years ago, I couldn’t believe that something like them wasn’t already standard practice across the board. Come to think of it, I felt the same way when I first heard of “evidence-based medicine” for the first time. Wait, you mean huge portions of medical practice (even if you don’t count so-called “alternative” “medical” woo like homeopathy) are not based on evidence? Yes, it’s unfortunately true, or at least it was true before evidence-based medicine began to gather steam in the last two decades. Take, for example, the Cochrane logo:

cclogo300x350

The logo is what is called a forest plot[1] and this one is a tragic reminder of the danger of not using systematic reviews. Each horizontal line shows the results of one study. The vertical line is the point where the treatment does not help people, but it doesn’t hurt them either. The left side of the vertical line means that the treatment is good and the right side means that it’s bad. The length of the line shows how precise the results are (the shorter the line, the more precise it is). If a line touches the vertical line, that means the treatment didn’t make a clear difference. The diamond at the bottom is what you get when you combine all the studies. In this case, it’s for giving hormones called corticosteroids to pregnant women who are going to give birth too early in order to prevent their babies from dying. The study at the top was done in 1972.[2] Ten years later, it should have been clear that the corticosteroids worked (we now know they reduce the odds of babies dying by 30% to 50%). But, a systematic review was not published until 1989, so many doctors did not know how good corticosteroids were. Because of that, tens of thousands of babies probably died.

 It’s not an exact science, and it takes a lot of hard work to develop systematic reviews, but they really do save lives and prevent needless suffering. However, even though Cochrane has the world’s largest database of clinical trials, it is still vulnerable to the effects of not reporting the results of trials, or of not even registering them in the first place. I’m glad to see them join the campaign to get all trials registered and all results reported.

1. Though the plots themselves were being used by at least the 1970s, the term “forest plot” itself was not used in print until 1996 in Pittsburgh in a poster presented at a meeting of the Society for Clinical Trials in May 1996.

2. The 1972 study looks like it should have been clear that corticosteroids are awesome after just one study, but it’s risky to trust just one study. Science works because we’re always testing each other’s theories and questioning our results. If no one else can get the same results, then we throw them out and try something else.

Advertisements

AllTrials Update

Since I first posted about the AllTrials campaign to have All Trials Registered and All Results Reported, it has gathered considerable support. More than 40,000 people have signed it and hundreds of organizations have joined as well, including GSK (one of the biggest pharmaceutical companies in the world), AMSA (American Medical Student Association), the British Medical Association, many disease-specific research and advocacy organizations.

Their new goals are:

  • One million signatures on the petition
    • Every 10,000 new signatures, they’ll send the petition to health ministers in every country and to regulators.
    • Share this link to spread the word.
  • More international organisations signed up. (unfortunately very few U.S.-based orgs)
  • £40,000 so they can keep going. Donate here.

Here’s a video (~90 min) of Ben Goldacre, one of the leaders behind AllTrials, explaining the problems with clinical trial reporting that make AllTrials is necessary. He was promoting his new book, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients, but it’s still a good talk. The book’s been sitting on my bedside stand for 2 months now. Hopefully I’ll get around to reading it soon.

Alltrials.net campaign for registration and reporting of clinical trials and their results

All Trials Registered, All Results Reported is a campaign calling for “governments, regulators and research bodies to implement measures to achieve” registration of all trials past and present and complete reporting of the methods and the results.

It is an initiative of Bad Science, Sense About Science, BMJ, James Lind Initiative and Centre for Evidence-based Medicine.

According to Bad Science, one of the initiative’s organizers, the recently-launched alltrials.net campaign has already collected over 7,000 signatures and includes leading organizations in the movement for open science &/or evidence-based medicine such as:

  • The Medical Research Council
  • The Cochrane Collaboration
  • IQWiG (the German equivalent of NICE)
  • PLoS
  • BMJ Group
  • Drug and Therapeutics Bulletin
  • The Open Science Federation

Please join me in signing the petition.

Secret goat herd found at the world’s #2 antibody producer

USDA officials discovered a herd of 841 goats in an allegedly unreported production facility owned by Santa Cruz Biotechnology, the world’s second-biggest supplier of antibodies for research. The Nature news article explains that investigators were tipped off to the facility where they found the goats, “some of which were lame, anaemic or had protruding bones.” The company was inspected nine times last year, far more than the normal once or twice. A pre-existing USDA animal-welfare complaint against Santa Cruz Biotechnology needs to be resolved by January 31 or a judge could suspend the company’s operations. I wonder what kind of an impact this would have on biotech research that uses antibodies currently only produced by Santa Cruz Biotechnology.

Breakthrough in Skin Cancer Detection

Researchers at Harvard have discovered a new biomarker for melanoma that could lead to new tests to detect it earlier and possibly even new treatments. What’s really cool is that it’s not a mutation in the genetic code itself, but the loss of a particular epigenetic marker–in this case 5-hmC (5-hydroxymethylcytosine). It’s great to have a new biomarker for this deadly disease, but it’s even better that this is an epigenetic one, since it’s really hard to change the DNA in the cells of a live animal. In fact the researchers also found, in their paper published in the Sept. 14th issue of Cell, that the downregulation of 2 enzymes was likely responsible for the loss of the 5-hmC epigenetic marker and that reintroducing those enzymes into mice with melanoma suppressed growth of the cancer and increased survival. That’s right – in a single paper, these scientists found a new way to test for melanoma and a potential new therapy for it.

 

Science FTW!