Novartis to allow researchers access to patient-level data for new drug approvals

Novartis will allow researchers access to patient-level data on newly approved drugs in the US and Europe in 2014, the company reported Wednesday. In addition, the drugmaker said it plans to create clinical study report summaries for all new pivotal trials in easy to understand consumer language and additional interpretation of data as of the end of the year.

Tim Wright, global head of development at Novartis Pharmaceuticals, remarked that the actions have been taken "to extend our leadership regarding clinical data transparency and access to data by researchers," adding "this is designed to further advance science and innovation which can benefit patients." Novartis spokeswoman Anja von Treskow indicated that the data could not be traced back to patients, while results from small trials of rare diseases will be excluded from the plan to ensure patient anonymity.

In January, Johnson & Johnson announced a collaboration under which Yale School of Medicine's Open Data Access Project will serve as an independent body to review requests from researchers and doctors seeking access to data from the company's clinical drug trials. The move follows similar commitments from GlaxoSmithKline and Pfizer, as well as Sanofi and Roche, as the European Medicines Agency moves ahead with proposals to proactively make trial data available to researchers once an approval decision has been made.

Novartis said that the patient-level data will be released through the same Internet portal used by other drugmakers, such as GlaxoSmithKline and Sanofi. The company acknowledged that the plan does not include access to older results, although it noted that it has voluntarily disclosed clinical study report summaries on its own website since 2005.

To read more Top Story articles, click here.