The AllTrials review of the world’s largest pharmaceutical companies’ trial registration and reporting policies is now published in the BMJ. This is the first time anyone has systematically examined and compared published company policies on trial transparency.
- Most of the largest companies, have a public policy about registering and reporting results from current trials.
- Only around half of the company policies we looked at mention trials carried out in the past. This is important because they include trials done on the treatments we use today. They are also the basis for measuring how effective new treatments might be
- Policies commonly don’t refer to trials on off-label treatments (common practice of using medicines for a condition they aren’t licenced for) or phase 4 trials (done after a treatment has been licenced to see eg if there are unexpected side effects). This means there is a loophole that thousands of trials may be falling through.
We also found that company policies are often vague, ambiguous, contradictory or difficult to interpret.
Dr Ben Goldacre, co-founder of AllTrials and lead author: “We found examples at the extremes of good and bad practice. Companies should make clear, simple commitments on what they will and will not share, so that we can all discuss their commitments, and to assess whether they are complying with their own policies. To make this easier, our paper includes a simple boiler-plate transparency policy that any company can modify and use.”
Dr Síle Lane, Sense about Science, which runs the AllTrials campaign, co-author of the paper: “Lack of policy on past trials is the biggest issue. Every day, as people and software retire, these are being lost. These include the trials on the treatments we’re using today, so they matter for patients now but also because they are the basis for measuring the effectiveness of proposed new treatments. The best evidence we have from academic research and automatic trackers suggests that we can’t see the results from around half of these trials.”
From policies to practice: AllTrials is now able to identify the mass of unreported trials and over the next two years we will be pursuing them. We would advise anyone who is sitting on an unpublished trial to move quickly to get the results reported, before we get to it.
AllTrials is working with over €3.5 trillion of investors who back the aim of trial transparency. The results of this review, particularly on past trials policy, are being incorporated into their framework for assessing the transparency of companies they invest in.
Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study, the BMJ (26 July 2017)
Auditing the transparency policies of pharma – Ben Goldacre and Carl Heneghan, BMJ talk medicine (29 July 2017)