Novartis reinforces its leadership in research with new global guidelines for Investigator Initiated Trials (IITs)

NovartisNovartis released today new global guidelines for Investigator Initiated Trials (IITs). Novartis has a strong history of supporting the funding of Investigator Initiated Trials (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 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.

About Novartis
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.

Most Popular Now

Bayer to accelerate drug discovery with Google Clo…

Bayer AG and Google Cloud announced a collaboration to drive early drug discovery that will apply Google Cloud's Tensor Processing Units (TPUs), which are custom-develope...

NextPoint Therapeutics announces $80 million Serie…

NextPoint Therapeutics, a biotechnology company developing a new world of precision immuno-oncology, announced today that it raised $80 million in Series B financing co-l...

AstraZeneca to acquire CinCor Pharma to strengthen…

AstraZeneca has entered into a definitive agreement to acquire CinCor Pharma, Inc. (CinCor), a US-based clinical-stage biopharmaceutical company, focused on developing no...

Acquisition of Neogene Therapeutics completed

AstraZeneca has completed the acquisition of Neogene Therapeutics Inc. (Neogene), a global clinical-stage biotechnology company pioneering the discovery, development and ...

Pfizer expands 'An Accord for a Healthier World' p…

Pfizer Inc. (NYSE: PFE) announced that it has significantly expanded its commitment to An Accord for a Healthier World to offer the full portfolio of medicines and vaccin...

500,000 missed out on blood pressure lowering drug…

Nearly half a million people missed out on starting medication to lower their blood pressure during the COVID-19 pandemic, according to research supported by the British ...

Roche announces the European Commission approval o…

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the European Commission (EC) has approved Xofluza® (baloxavir marboxil) in children aged one year and above for the trea...

Study identifies potential new approach for treati…

Targeting iron metabolism in immune system cells may offer a new approach for treating systemic lupus erythematosus (SLE) - the most common form of the chronic autoimmune...

Nanotechnology may improve gene therapy for blindn…

Using nanotechnology that enabled mRNA-based COVID-19 vaccines, a new approach to gene therapy may improve how physicians treat inherited forms of blindness. A collabo...

Modified CRISPR-based enzymes improve the prospect…

Many genetic diseases are caused by diverse mutations spread across an entire gene, and designing genome editing approaches for each patient’s mutation would be impractic...

Discovery of anti-cancer chemistry makes skullcap …

The evolutionary secrets that enable the medicinal herb known as barbed skullcap to produce cancer fighting compounds have been unlocked by a collaboration of UK and Chin...

A soybean protein blocks LDL cholesterol productio…

A protein in soybeans blocks the production of a liver enzyme involved in the metabolism of triglycerides and low-density lipoprotein, scientists found in a recent study...