A new paper published today in the BMJ by Ben Goldacre and lobby group Alltrials has shown that progress is being made on clinical trial transparency, although both say there is still a way to go.
The paper sought to identify the policies of 42 Big Pharma companies on transparency of trials, and to: “Extract structured data detailing each companies’ commitments, and to assess concordance with ethical and professional guidance.”
The paper found that policies “were highly variable,” and of 23 companies eligible from the top 25 companies by sales, 21 (91%) committed to register all trials and 22 (96%) committed to share summary results.
But, it found that policies “commonly lacked timelines for disclosure, and trials on unlicensed medicines and off-label uses were only included in six (26%).”
It said that 17 companies (74%) committed to share the summary results of past trials. And two companies fell short of industry body commitments on registration, three on summary results.
The paper said that, other than journal submission for all trials within 12 months, “all elements of best practice were met by at least one company, showing that these commitments are realistic targets.”
In a statement to FierceBiotech, AllTrials said it found that “company policies are often vague, ambiguously worded, internally contradictory or difficult to interpret.”
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."
Síle Lane, a co-author on the paper, added: “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 suggests that we can’t see the results from around half of these trials.”
AllTrials says it is now able to identify the mass of unreported trials, “and over the next two years we will be pursuing them.”
The group says it would “advise anyone who is sitting on an unpublished trial to move quickly to get the results reported, before we get to it.”