Clinical trials are considered by many to be the best way of testing the safety and effectiveness of a medicine. Thousands of volunteers trust that the information gleaned from the trial study is shared with the medical profession in the hope that it might assist in their recovery and in medical advancement.
So why it is that the results of so many trials are never shared and never used?
There is no current law in the UK compelling a UK company to report and publish the results of the trials that it commissions. This position may soon change.
An EU Directive, likely to be in force in 2017 or 2018, is set to change the current picture, that is, for as long as the UK remains legally connected to the EU.
Campaigners for change have long believed that not sharing results violates participant trust, and skews the assessment of drug trials, including their effectiveness. And what of medical advancement overall; surely a lack of transparency equates to a lack of authenticity, to false or no advancement?
Recent reports by scientists at the University of Oxford, and journalists at The Times, suggest that medical researchers involved in previous investigations have been deliberately withholding negative results from trials which have had the effect of portraying drugs as more effective than they actually are.
Imagine for one moment that a drug trial participant is advised in advance of the trial that the results yielded would only be shared if successful or indeed, not at all. What then for the drug trials market? One cannot help but wonder whether the world of clinical trials would exist.
Recent research conducted by scientists at the University of Oxford has been reported with shocking results that almost 50% of trials over the last 10 years remain unpublished. It has also been suggested that negative results are twice as likely as positive results to remain unreported.
The Oxford University Scientists engaged in the research have lambasted the position as “completely unethical” not least because the result is that the medical profession is not equipped with the evidence to prescribe drugs effectively.
The new and automated TrialsTracker service, developed by Oxford University scientists, looks likely to shine a light on the clinical trials reporting activity (or lack thereof) of universities, government bodies and pharmaceutical companies.
Itoperates by identifying trials that remain unpublished two years following trial expiry. The service has revealed that out of a total of 25,927 trials completed by major trial sponsors in the last 10 years, 11, 714 or 45.2% remained unpublished.
It has been estimated that the unpublished data relates to 8.7 million patients. There have been criticisms of the findings including that the methodology is imperfect, and the representation of results misleading.
It has been argued that publishing results of trials is dependent upon a journal’s acceptance of the manuscript from the study so that if a trial is inconclusive, poorly conducted or poorly written up, it may not get published.
It seems fair to conclude therefore that whilst some trial results may be abandoned for yielding undesirable results or otherwise concealed by the sponsor, to suggest that all unpublished trials remain unpublished for sinister reasons is wrong.
However, it does also depend on the reasons for the non-acceptance of the manuscript from the study by the relevant journal. The British Medical Journal makes it clear that since 2013 it will not publish any trial of drug or devices where the authors do not commit to making the relevant anonymised patient level data available, on reasonable request.
The message to trial sponsors appears clear; if you do not wish to be an identified sponsor in the “unpublished results” category, ensure your results are published and discoverable. Either publish or ensure your trial ID is in PubMed. Certainly, a closer look at the TrialsTracker service suggests that updating scores and posting results on the ClinicalTrials.gov website is simple.
Gene Matthews says: "I welcome the advent of the new TrialsTracker service.
“I firmly believe that the new TrialsTracker service in combination with the European Medicines Agency (EMA) website which provides access to clinical reports to new medicines for human use authorised in the European Union, can only serve to provide greater transparency across the board. Clinical trial results must be published; anything less is to subvert its very purpose”.