The World Health Organization (WHO) has issued an official statement to encourage pharmaceutical companies to disclose clinical trial results on a publicly accessible database following concerns that negative results are kept out of the public domain.
“Concerns have been raised that there may be selective publication of trials dependent on their results, with particular concern that trial results which may be viewed as ‘negative’, are less likely to be submitted, or accepted, for publication in the scientific literature or made public in other ways,” says WHO in the draft statement.
WHO says it wants details of any trial to be available to the public, free and on a searchable register before any person receives the first medical intervention. The data should be updated and the final results routinely available within 18 months of the trial ending. The results should also appear in a peer-reviewed journal within the 18-month deadline, it has proposed.
The statement, which was out for public consultation until 15 November 2014, follows the creation of the WHO International Clinical Trials Registry Platform, a global network of national clinical data registries.
WHO says there is evidence that a substantial number of clinical trials remain unreported several years after study completion, even in the case of large randomized clinical trials.
The move was welcomed by the Royal Pharmaceutical Society’s chief scientist Jayne Lawrence. “We fully support public access to clinical trial data, which is vital to calculating the potential benefits and harms of medicines to patients. As pharmacists, improving our knowledge of the safety of medicines is central to what we do and this relies heavily on the ready access to clinical trial data.”
The Guild of Healthcare Pharmacists (GHP) says the draft statement, will set “a strong global standard for clinical trial reporting”.
But the GHP wants the declaration to include potential sanctions if drug companies fail to meet the deadlines. “Although we agree with the statement there appears to be enough loopholes that it may not have the desired result, and without sanctions how enforceable would it be?”
The GHP is also worried that the data may be hard to find even if they are publicly accessible. “If the registry is buried deep within a website so that only those who know it exists can find it, that would meet the letter of the statement if not the spirit,” the GHP says in its response to the consultation document. “Then it would not matter if negative results were posted.”