Our 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.
We found:
- Most of the largest companies, though not all, have some sort of publicly stated policy about registering and reporting results from current trials.
- However, only around half of the company policies we looked at refer to trials carried out in the past.
- Policies commonly fail to refer to trials on unlicensed treatments or to phase 4 trials. This means there is a loophole that thousands of trials may be falling through.
We also found that company policies are often vague, ambiguously worded, internally contradictory or difficult to interpret.
The investigation was conducted between April 2015 and April 2016. The authors attempted to speak with every company several times. Just over half of the companies engaged: 11 out of 50 said that they would make some changes to their published policies because they did not reflect practice, or to clarify the issues raised.
Dr Ben Goldacre, co-founder of AllTrials and lead author, said:
“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, said:
“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.”
What now?
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 We would advise anyone who is sitting on an unpublished trial to move quickly to get the results reported, before we get to it.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.
Companies may now be conducting their business to a better standard than their published policies. In some cases we certainly hope so. We have created a page on AllTrials.net where companies can post these updates by emailing: alltrials@senseaboutscience.org.