When "Standard Treatment" Isn't Standard Everywhere: A Cushing's Syndrome Trial's Costly Spain Assumption
The barrier
A sponsor selected Spain as a site for a Phase 3 Cushing’s Syndrome trial. The protocol carried a seemingly straightforward exclusion criterion: no patients who had undergone radiotherapy within the past 10 years. In many countries, surgery is the primary post-diagnosis intervention, making that criterion low-impact. But in Spain, it isn’t: radiotherapy is a standard part of the treatment pathway after diagnosis. The assumption baked into the protocol didn’t account for that difference, and it threatened to disqualify a large share of the very patients the trial needed in Spain.
The insight
Access to therapy, treatment history, and diagnosis timelines vary by country, and they decide which patients are reachable and where. This is exactly the kind of mismatch Pathway is built to catch before site selection is locked in: visible upfront, it lets a sponsor choose a different country, or write the protocol amendment in from the start instead of discovering the problem mid-trial.
The outcome
Instead, the gap surfaced only after Spain was already selected and recruitment was underway, forcing a mid-trial protocol amendment that shortened the exclusion window from 10 years to 3. The result: impacted recruitment from ineligible patients, and unnecessary costs that knowing where the eligible patients actually were could have avoided.
Impact on client: Mitigated the impact on recruitment