Novartis expands clinical trial data transparency
Novartis has announced additional steps to extend its presence in clinical trial data transparency. Since 2005, and before requirements were in place, Novartis has been voluntarily disclosing summaries of Clinical Study Reports of its innovative medicines on its own web site (www.novctrd.com). In addition, the company is committed to enhancing Clinical Study Report summaries for all new pivotal studies to include easy to understand consumer language summaries and additional interpretation of data as of the end of 2014.
Novartis has long supported data transparency and was the first company to publish positive and negative study results of its innovative medicines within one year of the study completion, further enabling clinical research while protecting patient privacy.
To date, Novartis has registered 2,720 trials on ClinicalTrials.gov and published 559 trial results on the same site as well as 1,777 clinical study summaries (known as "redacted clinical study reports"). Researchers also can now request access to patient level data on newly approved innovative medicines in 2014 through the same Idea Point portal as other pharmaceutical companies.
"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," said Tim Wright, global head of development, Novartis Pharmaceuticals. "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."
Novartis has over 200 projects in clinical development, including 144 in the pharmaceuticals division. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for potentially best-in-class or first-in-class medicines that could significantly advance treatment standards for patients worldwide. In 2013, the company received 13 major approvals from regulatory authorities and obtained three Breakthrough Therapy Designations for investigative medicines from the FDA.