There has been a tendency in the past by various industry parties to view clinical trial data as “their” data and put forward technical justifications as to why only certain clinical data is published. However, campaigners for transparency have pretty well scuppered this position by pointing out that since patients are involved, they did not get involved in trials just for the results to stay hidden in some vault. This ethical and moral argument is one that resonates far better with the public than the laboured approach that many industry representatives use. Complicating the industry position further is the fact that some major companies are now publicly backing the Alltrials campaign.
However, what is really set to cause a big stir is the European Medicines Agency’s (EMA) impending policy on the proactive publication of clinical trial data. European regulators have not always been the best of friends with campaigners for data transparency, but the EMA’s current position will be hugely influential on how things develop from here. At the moment, a final round of consultations with key stakeholders is taking place and a final version is likely to be endorsed by the Agency’s management in June. When this policy is released, the impact is likely to be global. Already, there are signs that other regulatory agencies are reviewing their approaches to transparency. Greater data transparency is inevitable, but the measures to ensure that data are released and used in the right way so that patients actually benefit from the more open environment are still to be defined.
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