Novartis Reinforces its Leadership in Research with New Global Guidelines for Investigator Initiated Trials

Novartis has released new global guidelines for Investigator Initiated Trials (IITs). Novartis has a strong history of supporting the funding of IITs governed by internal operating processes and governance measures.

Novartis defines IITs as studies developed and sponsored by an independent investigator or academic sponsor. Clinical research undertaken through IITs must be based on the need to address meaningful scientific and/or clinical objectives supported by valid scientific designs while respecting the privacy rights, safety and welfare of patients.

An IIT may be a clinical or non-clinical study and is conducted without the participation of Novartis, where the sponsor of the IIT makes a request to Novartis to provide either funding, drug product or both. For these IITs, Novartis provides financial support and /or drug product according to a written agreement, which requires that third-party sponsors comply with applicable local laws and regulatory requirements.

"As part of our commitment to deliver innovative therapies to patients worldwide, Novartis believes in the need to support ethical clinical research," stated David Epstein, Division Head, Novartis Pharmaceuticals. "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 so that we are doing all we can to address unmet medical needs of patients."

The new IIT guidelines are based on six key principles:

1. Compliance with the highest ethical and scientific standards

2. Robust medical and scientific governance systems within Novartis

3. Global training on the guidelines for Novartis associates including the rules of independence of third party investigators/sponsors

4. Financial transparency on funding support

5. Contractual requirement of third party sponsors to publish findings and report any safety information

6. Ongoing tracking and monitoring within Novartis and transparent sharing of information with investigators/sponsors.

IIT processes in terms of study conception, design, operational execution, data handling, data interpretation, and subsequent reporting/publication must be independent of any Novartis commercial associate involvement. Scientific governance is also critical at both the research site and within Novartis and the rules regarding the interactions between the sponsor/site and Novartis must be clear and adhered to.

"Novartis' new global IIT guidelines released today reinforce our commitment to the principles of ethics, governance and transparency and our support of ethical clinical research," stated David Epstein, Division Head, Novartis Pharmaceuticals. "With these new Novartis guidelines IITs can occur in a fully compliant manner giving confidence to physicians and the results from IITs that could make a real difference for patients."