Thursday, October 24, 2013

LEO Pharma to release clinical trial data

Published on 24/10/13 at 03:52pm

leo pharma

LEO Pharma has announced that it will start releasing clinical trial data from studies dating back to almost 25 years ago.

The Denmark-based firm said it is using this as a “Declaration of its support for the increased global calls for transparency coming from many quarters”, which includes patient groups, researchers and think tanks.

In practical terms this means that from 1 January next year researchers, patient associations and healthcare professionals can gain access to LEO Pharma’s clinical trial data as it gradually posts summary results sponsored by the firm, that date back to 24 years on its corporate website.

In addition it will gradually post clinical study reports (CSR) for the same time period, starting with the most recent, with all CSRs available within the next three years.

This move comes amid Sense About Science’s AllTrials campaign, established earlier this year with the support of Ben Goldacre and the BMJ among many others, which has put pressure on the industry to release all data for new and old medicines that are not in the public domain. 

A spokesman for the company told Pharmafile it was ‘considering its options’ but as yet has not signed up to AllTrials. “However [LEO] are beginning to liaise with them [the AllTrials team] and this new policy does meet many of the AllTrials recommendations,” the spokesman added.

Geraldine Murphy, managing director of LEO Pharma UK & Ireland, said: “Transparency in relation to clinical trials data is a scientific and ethical responsibility that facilitates informed healthcare decisions. As such it is core to the values of LEO Pharma and we are pleased to pledge our support.”

The firm added that it would share clinical trials data in a way that would ‘not reveal identifiable personal data’.

Ben Goldacre, author, doctor and co-founder of AllTrials said: “This is excellent news from LEO Pharma. Their commitments, and the commitments from a growing number of other companies, stand in sharp contrast to the obfuscating pharmaceutical industry trade bodies who seem to want to keep secrecy as the norm.”

This move coincides with new rules in Europe, also set to start from January next year, which will ensure pharma releases more of its clinical trial data. This is being led by the European Medicines Agency, which from 2014 will no longer recognise trial data as confidential, meaning it can be shared with the public.

Not all in pharma have been happy about this, with both AbbVie and InterMune currently suing the Agency for releasing data related to two of their medicines.

The EMA came out this week saying that transparency will be a good thing for the industry, but the European lobby group EFPIA is still calling for data disclosure to be decided by pharma, not the regulator.

It looks as if LEO could well be getting ahead of the game by signing up to a transparency agenda now and going beyond what would be expected of it, especially through producing data from nearly a quarter of a century ago.

The process will however be relatively slow, and it is not yet clear just how this will tally with what the EMA may expect.

New board

The firm said it would also evaluate each request from researchers, healthcare professionals and patient associations to receive access to anonymised patient-level data for approved products dating back to 2000. A ‘Patient and Scientific Review’ board will be established to evaluate requests for patient-level data.

The board will comprise independent researchers and representatives from patient associations, and will meet four times per year to review requests for access to clinical trials data sponsored by LEO Pharma.

Gitte Aabo, president and chief executive of the firm, said: “LEO Pharma is a patient-centric company and for us that implies being transparent about the results from our clinical trials, so that we can enable patients and healthcare professionals to make informed decisions about treatment. We recognise the public health benefits associated with making clinical trials results available.”

Ben Adams

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