Novartis unveils new guidelines for investigator-initiated trials

Novartis has announced the publication of new global guidelines for investigator-initiated trials (IITs) as part of its commitment to supporting ethical clinical research.

IITs are studies developed and sponsored by independent investigators or academic sponsors. They are conducted without the direct participation of Novartis, which instead offers funding support, drug products or both.

The new guidelines will reinforce the requirement that no commercial funding, involvement or influence are permitted in any aspect of IITs, as well as underlining the need for compliance with the highest ethical and scientific standards.

Emphasising the principles of strong governance and transparency, the guidance will make it easier for qualified independent investigators to explore unmet medical needs in a responsible manner.

David Epstein, division head at Novartis Pharmaceuticals, said: "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."

The company is currently undergoing significant evolution following its recent acquisition of GlaxoSmithKline's oncology portfolio, which coincided with the sale of Novartis' vaccines division to the same firm.