Clinical trials are research studies intended to answer scientific questions and find better ways to treat or prevent diseases. They are fundamental to the development of innovative medicines and devices that treat and prevent illness.
Clinical studies are conducted to determine whether a new treatment is safe. Such studies are possible because volunteers (healthy volunteers and patients) agree to participate and try new medicines and devices.
Medicines and devices tested in clinical trials can be:
Not yet been approved by health authorities
Currently available for sale, and being tested to improve existing formulations or evaluate their potential in other diseases.
The success of clinical trials depends on the participation of volunteers. Participants in clinical trials gain access to new research treatments not yet available to the public while helping others by contributing to medical research.
Novartis is currently conducting clinical trials worldwide for a range of diseases.
Novartis recognizes the importance of informing the public about the results of its interventional clinical trials for innovative compounds, regardless of the outcome. We make the results of our clinical trials publicly available through peer-reviewed publications and posting of results on the Novartis clinical trial results database and other online public databases. Knowing the results of these trials enables both patients and their healthcare providers to make well-informed decisions regarding treatment risks and benefits.
Novartis is also committed to sharing with qualified external researchers, access to patient-level data and clinical study reports from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trials in line with applicable laws and regulations.
Novartis began in January 2014 to make available patient-level data with medicines that have received a regulatory approval for a specified indication in the EU and U.S., under the provision that Novartis maintains the ability to publish the relevant clinical trial results in scientific journals.
Novartis is committed to supporting Investigator Initiated Trials (IITs) as a part of the drug discovery and development process. Scientific research that is produced by qualified third-party investigators is key to complementing Novartis-sponsored research to help better understand the benefit/risk profile of our therapies as well as explore new opportunities to address unmet medical needs.
Novartis defines IITs as studies developed and sponsored by an independent investigator or academic sponsor. Novartis requires that clinical research undertaken through IITs 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 either a clinical or non-clinical study, conducted without the participation of Novartis for which the sponsor has requested that Novartis provide funding, drug product or both. Novartis provides financial support and/or drug product for IITs according to a written agreement, which requires that third-party sponsors comply with applicable local laws and regulatory requirements.