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 including:
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 Investigator Initiated Trial (IITs) 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."
Novartis Pharmaceuticals is committed to science-based innovation that makes a meaningful and measurable difference to patients' lives by delivering the right medicine to the right patient at the right time. The company's unique approach to drug development coupled with its vigorous investment in R&D has yielded important results for patients including a promising pipeline of more than 140 programs that is consistently rated as among the most respected in the industry. In 2013 alone, the company received thirteen major approvals from regulatory authorities and obtained three Breakthrough Therapy designations for investigative medicines from the U.S. Food and Drug Administration - among the highest number for any company.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world.