Clinical trial participants retain access to investigational treatments
Novartis exemplifies a comprehensive approach to post-trial access to investigational medicines
All diseases and patient populations
Providing clinical trial participants with continued access to investigational treatments
To reinforce clinical trial patients’ access to medicine
In 2018 Novartis was acknowledged for its exemplary post-trial access (PTA) policy. Today Novartis continues to ensure post-trial access to all patients who complete a Novartis-sponsored confirmatory superiority clinical trial or a trial of any phase investigating a serious or life-threatening disease.
This applies to all patients regardless of the severity of the disease, availability of alternative therapies or geographical location. As required or permitted by local legislation, the responsibility to provide post-trial access should last for as long as there is evidence of clinical benefit for the patient or until other criteria are met: i) the Investigator discontinues treatment, ii) the benefit-risk profile of the product in that indication is no longer positive, iii) the product becomes available after product launch and subsequent reimbursement, where applicable or iv) if a marketing application or reimbursement of an investigational product is rejected in a region/country for the indication under study.
Post-trial access applies to all patients regardless of disease severity, availability of alternative therapies or geographical location.
Reinforcing post-trial access mechanisms
Novartis has continued to strengthen and expand its commitment to post-trial access through several activities. The company has updated its internal guidance on PTA and developed a suite of tools, materials, and training to aid clinical teams’ decision-making on post-trial access. Reinforced by a strong commitment from leadership to the updated guidelines, Novartis affirms early PTA planning in all in-scope studies. As part of this approach, Novartis considers a range of post-trial access mechanisms, including blinded extension studies, open-label extension studies, roll-over-extension programmes and Post-Study-Drug Supply (outside of a clinical trial setting), where permitted by local laws and regulations.
The company has also introduced governance/escalation mechanisms for post-trial access, including a Consultation Board to provide guidance to global, regional and local teams on PTA. As regards the affordability for broader populations to treatments after registration, launch and reimbursement in countries where trials are conducted, the approaches described above are complemented by the activities implemented through application of the Novartis Access Principles. Affordability is a pillar of those principles to systematically integrating access strategies across Novartis’s portfolio.