A permanent neutral non-profit sponsor for multi-company platform trials
Trials that test many companies' drugs side by side against one shared control work best when nobody's company runs them. A standing non-profit sponsor would make this the norm rather than a rare exception.
A permanent, funded, non-profit organisation that acts as regulatory sponsor and operator for master protocols in which multiple companies contribute agents, on the model of QuantumLeap Healthcare Collaborative (I-SPY 2), the Lung-MAP public-private partnership, GBM AGILE and the UK's STAMPEDE. The sponsor holds the protocol, the shared control arm, the statistical engine and the data, and offers companies a standard entry contract with pre-agreed rights to use platform results for registration. Each platform today is built from scratch by heroic individuals; institutionalising the function lowers the cost and time of adding a new disease platform from years to months.
- 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.
- Trial design, endpoints and cost · A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on.
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