Detailed commitment to providing post-trial access, goes further than peers
Detailed and thought-through policy for providing investigational products to all clinical-trial participants until the product is commercially available.
The policy provides reassurance to clinical trial participants that the end of the clinical trial does not mean an end to treatment.
Conducting clinical trials in low- and middle-income countries raises ethical dilemmas where participants cannot continue treatment once a trial ends. Loss of access to promising experimental treatments once clinical trials end can have devastating health effects.
When people participating in clinical trials lose access to promising experimental treatments or comparable therapies, they may experience devastating health effects, especially for chronic diseases, e.g., HIV/AIDS. For vulnerable populations in low- and middle-income countries, without the means to access alternative treatments, this loss may be especially difficult and could lead to relapse or other worsening conditions. 'Post-trial access' describes the continued provision of a product to clinical trial participants after a trial has concluded.
Ensuring access after clinical trial completion
To address this issue, Novartis has taken a new position on post-trial access, publishing this position in August 2018. In a comprehensive, public policy on post-trial access, the company commits to provide free post-trial access to all patients who participate in and complete a confirmatory Novartis-sponsored clinical trial and meet certain criteria: there must be evidence of continued clinical benefit to the patient, and he or she must give consent to continue treatment. There must also be a lack of available alternative treatment options that are comparable or satisfactory. Finally, local laws and regulations must allow post-trial access to take place.
What makes this a best practice?
Novartis’ new policy goes into greater depth than the post-trial access policies of its peers. It also contains a greater range of patient groups eligible for continued treatment. The 2018 Index finds that 14 companies have (or make available) a post-trial access policy, although they vary in their level of rigour. Those companies that do have post-trial access policies often stipulate that for participants to continue to receive treatment, they must demonstrate a life-threatening or serious illness, one for which no alternative treatments are available.
Novartis considers all patients for post-trial access
Although it requires the absence of a comparable or satisfactory alternative for treatment, Novartis considers all patients for post-trial access, regardless of the severity of disease. Its policy includes additional protection: if withdrawal of treatment might lead to substantial harm or relapse, Novartis will provide post-trial access, even where alternative marketed therapies are available.
In a further provision, when clinical trial results demonstrate the superiority of a product under investigation, Novartis commits to offering this product to all trial participants until the product becomes available commercially, or accessible locally. In September 2018, Novartis was conducting at least 90 clinical trials in 19 countries in scope, which highlights the potential reach of this policy.