Wednesday, December 05, 2012

Embrace the change

Pharma should embrace data transparency: Sanofi exec

Sanofi's chief strategy officer David-Alexandre Gros has said the pharmaceutical industry should have nothing to fear about publishing raw data from clinical trials, a stance not shared by a number of drugmakers.

The Financial Times Global Pharmaceutical and Biotechnology conference in London burst into life when one of the panel discussions turned to the topic of companies publishing complete raw datasets from their clinical trials. The spotlight has been on the latter of late, driven by campaigners such as the BMJ, the Cochrane Collaboration and Bad Pharma author Ben Goldacre, with increasing calls for public access to trial outcomes, whether they are positive or negative.

Mr Gros was taking part in a discussion on new operating models for pharma with David Morris, global head development franchise, primary care at Novartis, and Jane Griffiths, company chairman of Janssen Europe, Middle East and Africa. When the debate turned to the issue of clinical trial transparency, Mr Morris said the release of raw data was a "challenging" issue that has to be managed appropriately.

Ms Griffiths added that publishing raw data prior to approval is not a good idea, saying that "a modus operandi" needs to be built first. Her view and those of Mr Morris were echoed by a number of speakers and many attendees speaking to PharmaTimes World News at the conference.

However Mr Gros broke ranks from the cautious tone being adopted by his peers at the meeting and said that the pharmaceutical industry should adopt "a less defensive posture". He added that "we should be comfortable with sharing data" and that there is no reason for drugmakers to be "scared".

Mr Gros went on to say that scientists need access to clinical data both negative and positive to improve their knowledge and help them develop treatments to meet unmet medical needs.

http://www.pharmatimes.com/Article/12-12-05/Pharma_should_embrace_data_transparency_Sanofi_exec.aspx?



No comments: