Novartis' pitch to join trial data sharing bandwagon gets frosty reception

In recent months, clinical trial data-sharing initiatives have become a must-have for Big Pharma companies, but some have embraced the idea more fully than others. While Johnson & Johnson ($JNJ) was cautiously lauded for its initiative, Roche's ($RHHBY) project was pilloried. Now Novartis ($NVS) has joined its Swiss peer in rolling out an underwhelming transparency program.

Novartis is making its patient-level data available through an online portal that is already used by GlaxoSmithKline ($GSK), Roche, Sanofi ($SNY) and other companies. The portal limits drugmaker influence in the decisionmaking process by having an independent four-person panel review applications, but other aspects of Novartis' initiative fall short of transparency advocates' ideal model. In particular, Novartis' decision to only release data for newly approved drugs has disappointed campaigners. 

"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. … It's not even a start. … We need the full methods and results of all the trials on those drugs. Anything less puts patients at risk," Bad Pharma author Dr. Ben Goldacre told Pharmafile. The decision to withhold data on existing drugs means Novartis' program is more limited than initiatives at some of its peers. J&J, for example, is sharing data from as far back as records go.

While Big Pharma is clearly keen to appear on board with transparency, doubts remain about its actual level of commitment. The portal used by GSK, Novartis, Sanofi and others so far only lists 6 requests with signed data-sharing agreements. Transparency campaigners and European politicians alike want companies to go beyond current initiatives. Regulations that would make transparency a requirement for companies selling drugs in the European Union are in the pipeline, and individual nations are also pushing for greater openness.

"Transparency is important for patients, the public, researchers and the NHS, and it can be achieved through ensuring trial registration and outcome publication, as well as making data available through the appropriate channels. I think that the new EU regulation will be extremely helpful in promoting transparency, and the availability of summaries of all trials and clinical study reports will be a part of that regulation," British health minister Earl Howe told the House of Lords.

- here's the Pharmafile piece
- read Bloomberg's article
- view FierceBiotech's coverage
- check out Novartis' release
- and the Lords debate

Industry Voices: Clinical trial transparency--time for some carrot as well as more stick?

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