Novartis has become the latest pharmaceutical company to introduce a controlled access route to patient-level data from its clinical trials.
Researchers can now request access to patient-level data on the company’s newly approved innovative medicines in the United States and European Union through the ideaPoint portal.
In January, it emerged that Boehringer Ingelheim, GSK, Sanofi and ViiV Healthcare had agreed to make anonymised patient-level data from clinical trials available to researchers on request through an online portal launched by ideaPoint, an enterprise-software specialist based in Quincy, US.
Access to those data was subject to assessment and approval by an independent review panel. It also depended on the study sponsors having listed the relevant trials on the site.
Novartis said it was further committed to enhancing Clinical Study Report (CSR) summaries for all of its new pivotal studies by incorporating easy-to-understand consumer language and additional data interpretation as of the end of 2014.
CSR summaries
The company already makes public summaries of CSRs on its innovative medicines through its website at www.novctrd.com. According to Novartis, it was the first pharmaceutical company to publish summaries of clinical-trial results within one year of study completion.
The company will continue to publish detailed summary reports of clinical trial results for innovative medicines, both positive and negative, it noted. These reports include trial designs as well as key efficacy and safety data.
To date, Novartis has registered 2,720 trials on ClinicalTrials.gov and published 559 trial results on the US-based site, as well as 1,777 clinical study summaries or ‘redacted clinical study reports’.
Patient rights
“Novartis has taken action to extend our leadership regarding clinical data transparency and access to data by researchers,” stated Tim Wright, global head of development for Novartis Pharmaceuticals.
“We also believe that patient rights and privacy remain paramount, and recognise that such data should not be released without the express consent of the patient,” Wright added.
