A regulator-endorsed standard contract for inter-company combination trials
Most of the delay in testing two companies' drugs together is lawyers negotiating from scratch. A single standard agreement, blessed by regulators, would let them sign in weeks.
A model clinical collaboration agreement for combination studies, covering supply, cost sharing, safety data exchange, publication, data ownership, background and foreground IP and regulatory filing rights, developed by an industry consortium (TransCelerate or a similar body) with academic networks and endorsed by the FDA and EMA as consistent with their combination-development guidance. Companies pre-commit to accept the template without modification for trials meeting defined criteria. Standard templates have cut contract time dramatically in academic-industry clinical trial agreements (for example the UK's model Clinical Trial Agreement and the US Accelerated Clinical Trial Agreement).
- Secrecy and intellectual property block collaboration · Companies with complementary drugs rarely test them together, and data that could answer questions stays locked up.
- Too many combinations to test · There are thousands of possible drug pairs and sequences. Trials can test a few dozen a year.