ideasIdea
Competing sponsors share one control arm in the same indication
Three companies testing three drugs against the same standard treatment each recruit their own control group. Pooling those controls in one shared study would need fewer patients and answer faster.
A neutral academic sponsor runs a master protocol in a defined indication with a single concurrent control arm; each company adds its experimental arm under a pre-agreed data-access and publication charter, paying a per-patient fee. Randomisation is concurrent, so this is a true RCT for each comparison. Precedents include the Lung-MAP and I-SPY structures, but industry-led registrational use is rare.
Hypothesis
A shared-control master protocol will reduce total patients randomised to control by more than half across participating programmes and produce registrational-quality comparisons acceptable to regulators.
Rationale
Control patients receive no experimental benefit and are the largest avoidable cost across a competitive indication. Regulators have signalled openness to master protocols for registration.
What would test it
Convene sponsors developing agents in one crowded first-line setting under an antitrust-cleared charter; run the shared-control protocol for one round of arms and compare efficiency with the sponsors' stand-alone plans.
Maturity
speculative
Who has to act
industry
Cost to try
Medium ($1M to $50M)
Years to first evidence
4
Bottlenecks it attacks
- 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.
- Trials enrol too few, too slowly · Fewer than one in ten adults with cancer joins a trial. Trials close for lack of patients, not lack of ideas.
- Secrecy and intellectual property block collaboration · Companies with complementary drugs rarely test them together, and data that could answer questions stays locked up.