News Feature | July 14, 2014

Novartis Posts New Global Guidelines For IIT Trials

By Estel Grace Masangkay

Novartis declared that it is implementing new global guidelines for Investigator Initiated Trials (IITs). The company defined IITs as studies sponsored and developed by either an academic sponsor or independent investigator, with or without the involvement of Novartis. IIT trials usually require the company to supply either funding and/or the drug candidate. Novartis outlined six principles that will guide its new IIT guidelines:

  • Compliance with the highest ethical and scientific standards
  • Strong medical and scientific governance systems within the company
  • Global training on company guidelines regarding Novartis associates and third party investigators/sponsors
  • Financial transparency on funding support
  • Contractual requirement of third party sponsors to publish findings and safety concerns
  • In-house tracking and monitoring; transparent sharing of information with investigators/sponsors

The company dictates that IIT processes must be independent of the participation of any Novartis commercial associate. It also emphasized the importance of scientific governance as well as clear rules regarding company and sponsor interactions.

“Independent research conducted by qualified third-party investigators is not only an important part of the drug discovery and development process but can complement our own Novartis research,” said David Epstein, Division Head of Novartis Pharmaceuticals.

Novartis has taken measures in the past in an effort to advance progress in clinical trials and drug development. The company announced in February its publication of 559 trial results and 1,777 clinical study summaries in the ideaPoint portal. Novartis opened access to patient level data on newly approved drugs in the EU and U.S. In addition, the company voluntarily revealed summaries of Clinical Study Reports (CSR) on its website.

In 2013, the company partnered with Pfizer and Eli Lilly to establish a consistent structure for the sharing of clinical trial data with patients. This is to help patients find trials that match their profile and, in doing so, to help speed enrollment and ultimately drug development.

Commenting on the new IIT guidelines, Eipstein said that the company hopes IITs can take place in a fully compliant manner for the benefit of physicians and patients alike.