Novartis Issues New Guidelines for Investigator Initiated Clinical TrialsBy
Novartis has released new global guidelines for Investigator Initiated Trials (IITs). Novartis defines IITs as studies developed and sponsored by an independent investigator or academic sponsor. in issuing the guidelines, Novartis emphasized that 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.
The new IIT guidelines are based on six key principles including: compliance with the highest ethical and scientific standards; robust medical and scientific governance systems within Novartis; global training on the guidelines for Novartis associates including the rules of independence of third-party investigators/sponsors; financial transparency on funding support; contractual requirement of third party sponsors to publish findings and report any safety information; and ongoing tracking and monitoring within Novartis and transparent sharing of information with investigators/sponsors.
Novartis emphasized that 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,” said Novartis is a company statement.