Thursday, 10 April 2014

Everyone’s talking transparency

We are hearing a lot about transparency these days. Regardless of the sector you work in, everyone is very keen to show that they have nothing to hide. In the world of pharma a big talking point is transparency regarding clinical trial data, driven by longstanding concerns over the selective publication of trial results. The worry is that unless all data for clinical trials are available then no one really knows on what basis clinical decisions about new drugs and other healthcare interventions are made. Several campaigners have suggested that selective reporting of trial results has already had a negative impact on patient health outcomes and that this situation is no longer tolerable. Now with media attention focused on specific examples of drug companies’ perceived reluctance to publish data on all their drug trials, coupled with the persuasive messages from the Alltrials campaign, things are set to change.

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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