Replicating a successful transparency program operated by Sense About Science in Europe, Sense About Science USA last week launched an American version of its campaign to get pharmaceutical companies to both register their clinical trials and then reveal the data – all the data – those trials generate.
“Imagine,” asked Steven Woloshin, a professor at the Dartmouth Institute for health policy and clinical practice, “there was an election. Would you trust the results if only half of the votes were reported? Imagine if the winner of the election was the one who decided which half of the voting was reported? That would be crazy, but that’s what the situation is when trials are not reported.” The institute, along with Dartmouth’s Geisel School of Medicine and Sense About Science USA are leading the US arm of the now international effort known as AllTrials.
As detailed on the AllTrials website, “Millions of volunteers have participated in clinical trials to help find out more about the effects of treatments on disease, yet that important ethical principle about reporting [detailed in the now 50-year-old Declaration of Helsinki] has been widely ignored. Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated.” As an Economist leader noted last month, the missing data created “a polluted evidence base” that at best wastes time and money and at worst costs lives.
And so the AllTrials campaign began in January 2013 with four specific requests:
- Make public that a clinical trial has been (or is being) conducted by logging it on an open register;
- Give a brief summary of the trial’s results;
- Provide full details about the trial’s methods and results; and
- Release individual patient data from the trial.
The requests are directed at both pharmaceutical companies and academics. As The Economist opined, “If anything, academics have an even worse record of disclosure than firms.”
The initial campaign is now supported by thousands of individual patients, clinicians and researchers across the world, and by hundreds of organizations representing millions of people. In its second week, some 51 mostly medically oriented organizations have joined the U.S. effort already.
The concept gained a big shot in the arm in April when the World Health Organization extended its 10-year-old call for all future clinical trials to release their data within a year to encompass all past trial too, since the medicines and therapies currently in use all came from past work. (WHO has operated the the International Clinical Trials Registry Platform since 2005.)
As WHO detailed in an article in PLoS Medicine:
The Declaration of Helsinki and other statements have outlined the compelling reasons why interventional clinical trials should be reported in a timely fashion. In brief, not reporting clinical trial results is likely to lead to dissemination bias. This bias has the following major adverse consequences:
- It affects understanding of the scientific state of the art.
- It leads to inefficiencies in resource allocation for both research and development and financing of health interventions.
- It creates indirect costs for public and private entities, including patients themselves, who pay for suboptimal or harmful treatments.
- It potentially distorts regulatory and public health decision making.
“Patients want the treatments that are best for them,” explained campaign co-founder Ben Goldacre, a medical doctor and author of the best-selling Bad Science (which shares the name of his popular blog). “This needs good quality evidence on what works. Unfortunately, we now know that around half of all clinical trials, on the treatments we use today, are withheld from doctors, researchers, and patients. This makes a mockery of our efforts to make truly informed decisions. It also puts the reputation of the entire medical profession—and pharma—on the line.” (Click here for Goldacre and Sense About Science’s Sile Lane’s description of the history of AllTrials.)
In addition to Sense About Science, the AllTrials campaign is an initiative of Bad Science, BMJ, Centre for Evidence-based Medicine, Cochrane Collaboration, James Lind Initiative and PLOS. To join the campaign, sign the AllTrials petition or get involved more energetically. To sign the petition on behalf of an organization, email your organization’s logo and a short statement to firstname.lastname@example.org. And to make a donation to the AllTrials campaign, please click here.