Novartis Takes Clinical Trial Data Transparency A Step Further
Novartis announced it is taking additional steps to extend transparency in clinical trial data with the launch of Idea Point portal. Researchers can now request access to patient level data on newly approved innovative medicines in the US and EU this year through the portal.
The company said it is committed to enhancing Clinical Study Report summaries for all new pivotal studies. The summaries will include easy to understand consumer language and additional interpretation of data by the end of 2014. Novartis has long supported data transparency and has been voluntarily disclosing Clinical Study Reports summaries since 2005, before the practice was required. Novartis is the first pharmaceutical company to publish summaries within one year of study completion. This enables clinical research while avoiding invasion of patient privacy.
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 recognize that such data should not be released without the express consent of the patient.”
A total of 2,720 trials have been published by Novartis on ClinicalTrials.gov to date, with an additional 559 published trial results and 1,777 clinical study summaries, also known as redacted clinical study reports. Medical researchers can now request access to patient level data through Idea Point portal as well as other pharmaceutical companies.
At present, the company has more than 200 projects in clinical development including 144 in the Pharmaceuticals Division. Projects range from new molecular entities to additional indications and different formulations for marketed drugs that the company sees as potentially best-in-class or first-in-class medicines in their fields. Novartis remains an active player in the pharmaceutical and healthcare arena, with 13 major approvals and three breakthrough therapy designations for investigative treatments from the U.S. Food and Drug Administration in 2013 alone, among the highest number for any pharmaceutical company.