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Novartis extends trial transparency

Published on 27/02/14 at 10:54am
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Novartis has become the latest pharmaceutical company to allow greater scrutiny of its clinical trial data.

The Swiss firm announced today that researchers would be able to request information on medicines that were newly-approved in the US and Europe through an internet portal called ‘Idea Point’.

Novartis’ plans do not, however, include access to older data.

It said in a statement that it is also “committed to enhancing Clinical Study Report summaries for all new pivotal studies to include easy-to-understand consumer language summaries and additional interpretation of data as of the end of 2014”.

Tim Wright, global head of development at Novartis Pharmaceuticals, said: “Novartis has taken action to extend our leadership regarding clinical data transparency and access to data by researchers.

“This is designed to further advance science and innovation which can benefit patients. We also believe that patient rights and privacy remains paramount, and recognise that such data should not be released without the express consent of the patient.”

Inconsistent release

The trend seemingly spreading throughout the industry sees Novartis join Leo Pharma, GlaxoSmithKline, Sanofi and Johnson & Johnson in releasing more data.

But each firm has different ideas about just how much data it should make available. J&J announced in January that it would work with Yale University’s Open Data Access Project (YODA) to release years of its drug findings to outside researchers.

In the same month Sanofi announced that it would expand access to information and data from its own trials - but made it clear that this would only relate to information on products from 1 January 2014.

From the beginning of this year also Leo Pharma has been slowly releasing clinical trial data from studies dating back 24 years.

And finally GlaxoSmithKline, the first major drug company to laud the principles of transparency, is currently the only big pharma firm to sign up the UK-based AllTrials campaign group, established by Dr Ben Goldacre, the BMJ and Sense About Science.

Since signing the AllTrials register a year ago, the London-based firm has now added its anonymised patient-level data from the online request system it launched in May last year, to a new multi-sponsor request system (clinicalstudydatarequest.com) that includes studies from many organisations.

GSK was also the first pharma company to allow outside researchers online access to detailed trial information - although it is yet to allow full, unfiltered access to all of its raw data.

Speaking about this issue in January the House of Commons Committee of Public Accounts expressed dismay over those companies who were not releasing data.

And even those such as GSK and Novartis who are, the PAC still found that most of the plans don’t go far enough as companies will not include a number of past trials, which are relevant to products currently in use.

Dr Goldacre told Pharmafile: “This isn't the information we need. Restricting transparency to only new drugs - while still withholding information on the drugs we are already using - is a tiny dent. New drugs are a tiny fraction of all prescribing; it's not even a start: we will be using the drugs we use today for decades.

“We need the full methods and results of all the trials on those drugs. Anything less puts patients at risk.”

European debate

This debate is certainly not confined to British shores and comes as the European Medicines Agency is looking to make pharma open-up its data for public scrutiny from this year.

The EU regulator has said that from 2014 it will no longer view trial data from pharma as ‘commercially confidential information’, meaning that all data could potentially be seen by those outside of the EMA, something that has never happened before.

The plans were expected to come into force from January but the European pharma industry, as represented by EFPIA, has criticised the campaign.

EFPIA says it may lead to private patient data being shared and also worries that competing firms may use these data to outfox their rivals on new medicines.

Given the growing furore the EMA said it would delay the plans in order for it to go through the thousands of responses it received, whilst its plans were out for consultation in 2013.

Ben Adams

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