Patient protection
We strive to ensure that the rights, safety and well-being of patients are protected and that clinical trial results are valid and credible. All clinical trials are designed in accordance with ethical principles embodied in the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines, and national and international regulatory requirements. In the interests of patient safety, scientific integrity and transparency, we also believe we must respect and defend the independence of researchers and their freedom to participate in and approve all aspects of a clinical trial, including the results.
All of our clinical investigators have access to their own data once results have been processed and consolidated according to the agreed protocol, and all receive a summary on completion of the study's clinical report. We also ensure that authors of a publication on a trial receive a full clinical trial report.
Novartis supports transparent communications, independent opinions and full disclosure of any possible conflicts of interest by investigators and authors of clinical trial publications. In keeping with the guidelines of the International Committee of Medical Journal Editors (ICMJE), we believe authorship should accurately reflect substantial contributions to the design and conduct of a clinical trial and subsequent drafting of a publication manuscript.
Our clinical trial efforts are fully aligned with our commitment to provide patients with the broadest possible access to balanced information about the medicines they take, consistent with local regulatory agency guidelines. The Internet has become an important medium for patients and healthcare professionals. Novartis offers its clinical trial results via the Internet on a non-promotional basis to advance the public good and public health.
Learn more on the the Declaration of Helsinki
Visit the International Committee of Medical Journal Editors (ICMJE) website