The Academy and ABPI today published the report of the FORUM workshop on ‘oncology endpoints in clinical research’.
One in two people will develop cancer at some point in their lives. As a result, there remains an urgent need for new and improved cancer treatment and management, and ensuring that such therapies are made available to patients.
Advances in our understanding of the underlying mechanisms of cancer have driven the recent development of innovative therapeutic approaches, novel trial designs and adaptive regulatory pathways. These scientific developments increasingly demand the development of new, or surrogate, endpoints. Surrogate endpoints for overall survival can provide a much faster read-out on estimated survival in oncology trials than initially measuring overall survival itself, potentially enabling faster access to innovative treatments for patients. In addition, new endpoints can capture a range of important factors beyond longevity such as those related to quality of life, and should be considered in the context of clinician, patient and regulatory needs.
Therefore the Academy and ABPI held a joint FORUM meeting on endpoints in oncology on 3 July 2017 to answer the question: What constitutes a meaningful endpoint in oncology given the distinct needs of different stakeholders? Participants discussed recent scientific progress and the value and potential of using different endpoints. However, it was agreed that to enable effective and safe use of these endpoints, a robust evidence base for their association with different outcomes, and utility and validity in clinical practice, is needed, with a multi-stakeholder approach. The meeting report provides a summary of the discussions and can be found on the righthand side of the page.
The Academy of Medical Sciences’ FORUM was established in 2003 to catalyse connections across industry, academia and the NHS, and the regulatory, charity and wider healthcare sector. Since then, a range of FORUM activities and events have brought together researchers, research funders and research users from across academia, industry, government, and the charity, healthcare and regulatory sectors. Further information and details of future events can be found on the FORUM homepage.