Novartis to Join Glaxo & Sanofi in Clinical Trial Data Transparency Effort


Novartis AG (NYSE:NVS) announced in a press release Wednesday that it will be joining rival pharmaceutical companies such as GlaxoSmithKline Plc (NYSE:GSK) in a clinical trial data transparency effort. Novartis will now allow researchers to request access to patient level data on newly approved innovative medicines in the U.S. and European Union via an internet portal known as Idea Point, which is also used by competitors Glaxo and Sanofi SA (NYSE:SNY).

The company also said it is “committed to enhancing Clinical Study Report summaries for all new pivotal studies to include easy to understand consumer language and additional interpretation of the data” by the end of 2014.

“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,” stated Tim Wright, Novartis’ Global Head of Development. “We also believe that patient rights and privacy remains paramount, and recognize that such data should not be released without the express consent of the patient,” a press release stated Wednesday.

Bloomberg notes that the new Novartis initiative will not allow researchers access to older data from past trials, however. Other drugmakers, including UK-based GlaxoSmithKline and France-based Sanofi have proposed greater disclosure of test results for medicines, but none of the companies have expanded their plans to include access to past trials. A UK House of Commons Committee of Public Accounts notes that these older trials are relevant to products currently on the market, in a statement released in January.

“Opening up information about all clinical trials to medical researchers would support the work of regulators by permitting thorough, independent external review by doctors and researchers,” the committee said, per Bloomberg.

Novartis spokesperson Anja von Treskow assures the public that the data cannot be traced back to individual patients, and that data from small trials in rare diseases will not be part of the new transparency measures, to insure patient anonymity.

The U.S. has required that drug companies register clinical trials since 1997, but pharmaceutical companies have largely been left to their own devices regarding the amount of data from the trials that they actually disclose to the public.