Pharma has still got some way to go to improve industry-wide publication of clinical trial results, as the AllTrials audit shows in stark detail.
The mixed picture it presents should enhance the reputation of those companies placed at the upper end of the scale.
One of those is LEO Pharma. Ranked second-best overall for its approach, AllTrials put it in first place for publishing both clinical study reports and summary results, and second place for releasing individual patient data.
LEO’s VP for Europe North Geraldine Murphy (pictured above) sat down with PME to talk about trial transparency and why opening up is so important.
“Trial transparency is a movement, and while we are delighted to be in second place for that, we are still a very patient-centred company and one of our core values is integrity,” she says.
“We strongly believe that the more we can do to enhance the understanding of the way drugs work, the better off patients will be. We have a scientific and ethnical responsibility to make clinical trial data available because of this.”
LEO Pharma announced its commitments to trial transparency back in 2013, following a workshop on clinical trial data and transparency conducted by the European Medicines Agency (EMA). The meetings that followed the workshop led to the European Parliament passing a new EU clinical trials regulation vote a year later.
That’s due to come into effect in 2019, when it will harmonise the assessment and supervision processes for clinical trials throughout the EU.
It will require all summary results to be published within a year of a trial ending, results summaries published within 12 months of the end of the trial, and clinical study reports released after the drug is licensed.
“We comply with the EU requirements, which is a tough but reasonable process. Clinical study reports are a critical part of the regulatory and clinical documentation so it’s really important that they are done correctly. Once a patient undertakes their last clinical visit it could take up to six months to work through the process. It’s a lot to do within a year and timelines are tight, but they’re the ones that we have committed to.”
The EMA’s new clinical trial portal and database, whose default position will be to make documents and data public at the first opportunity, should speed up the direction of travel.
However, it’s possible Brexit may slow this down. The EMA’s work on developing a transparency roadmap, which will set out its future transparency measures, is one of a handful of activities temporarily suspended in order to enable staff to focus on preparing for the UK’s exit from the EU.
Another issue of concern is finding a way to use past data from medicines that are already on the market, although Murphy explains that is not a particular issue for LEO.
“We have published our clinical reports and studies for our approved products dating back to 1990. Our own policy is to publish results of all phase III clinical trials, regardless of whether the outcome of the study is positive or negative, as all data is important.”
She added: “Sometimes you can learn as much if not more from a negative study as you can from a positive one.
“Every company has their own policies regarding trial transparency, but we need to begin to learn to trust each other and the regulatory system. It can only be helpful to have more transparency in clinical studies.”