Research based companies are required to prove the safety and efficacy of all new medicines in clinical trials. Clinical studies in humans must comply with ethical principles, as agreed in the Declaration of Helsinki, which protect the safety and well-being of the study participants. All Novartis clinical studies are therefore designed and conducted in accordance with the ethical principles of the Declaration of Helsinki Good Clinical Practice guidelines as well as national and international regulatory requirements.
Clinical trial information disclosure at Novartis
Providing access to information about clinical research studies and their results benefits study participants, patients, healthcare providers and the wider public. This information helps people make informed decisions about potential treatment options as well as potential participation in clinical studies. Novartis therefore makes every effort to comply with national and international standards for disclosure of clinical trial information and is committed to the timely disclosure of the design and results of all interventional clinical studies for innovative treatments in patients. Results are made publicly available whatever their outcome.
Novartis informs the public about the results of its interventional clinical trials in patients for innovative compounds, regardless of the outcome. The results of Novartis clinical trials are made publicly available through peer-reviewed publications and posting of results on the Novartis clinical trial results database and other online public databases.
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.
Availability of patient-level data is starting with medicines that have received a regulatory approval for a specified indication in the EU and U.S. from January 2014 onwards, under the provision that Novartis maintains the ability to publish the relevant clinical trial results in scientific journals.
For more detailed information about patient-level data eligibility criteria and for external access requests, view our Clinical Study Requests.