ideasIdea

Patient panels approve trial burden and endpoints as a condition of funding

Before a trial is funded, patients who have had the disease sign off on how many visits, scans and blood draws it demands, and on whether the endpoints measure things that matter to them.

Trial protocols are written by sponsors and statisticians; visit burden, exclusion criteria and endpoints reflect regulatory habit rather than what participants can tolerate or value. Funders (public and charitable) would require a structured patient review of burden, eligibility and endpoints, with a published response to each recommendation, before release of funds. PCORI and some UK funders already require patient involvement; this makes it a gate with teeth and a measurable output.

Hypothesis

Patient-gated protocols recruit faster and retain more participants (dropout down by a quarter) and include at least one patient-prioritised endpoint in over 80% of cases.

Rationale

Feasibility failures are the commonest reason trials close early. Patients are the best judges of what they will actually do for two years.

What would test it

Funder adopts the gate for half of its calls at random; compare accrual rate, dropout and endpoint composition between gated and ungated trials over three years.

Maturity

early clinical

Who has to act

philanthropy

Cost to try

Small (under $1M)

Years to first evidence

Bottlenecks it attacks

Patients lack understanding, navigation and agency · Most patients cannot understand their options, find trials, or push back, so decisions are made for them.
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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bottlenecks

Patients lack understanding, navigation and agency Trial design, endpoints and cost