Clinical trials to establish the efficacy of new agents in the adjuvant cancer setting typically take many years to complete. During that time, external factors can impact recruitment and reporting plans. An example is a new standard of care becoming available during the recruitment period. In this paper we describe how we modified the design of the RAMPART trial (NCT03288532) which was set up to investigate immune checkpoint inhibitor therapy in the adjuvant renal cancer setting. The trial had been initiated when no globally accepted adjuvant strategy after nephrectomy existed. A subsequent change in the standard of care for many patients with early renal cancer meant it was no longer feasible to continue to recruit. We needed to find a way to maximise the contribution that RAMPART participants could make to the evidence base for immune checkpoint inhibitor therapy without introducing bias or detriment to the integrity of the trial results. We describe how we agreed and incorporated all design and timeline changes while remaining blinded to accumulating data within the trial, thus protecting the reliability of the future results. We share details of our design modifications to guide others who may have similar experiences, particularly as more agents and combinations of agents are developed and investigated in similar adjuvant settings.
Contemporary clinical trials communications. 2024 Oct 18*** epublish ***
Angela Meade, Elena Frangou, Babak Choodari-Oskooei, James Larkin, Tom Powles, Grant D Stewart, Laurence Albiges, Axel Bex, Toni K Choueiri, Ian D Davis, Tim Eisen, Alison Fielding, Craig Gedye, David J Harrison, Rick Kaplan, Salena Mulhere, Paul Nathan, Grisma Patel, Jay Patel, Hannah Plant, Alastair Ritchie, Hannah Rush, Clare Shakeshaft, Martin R Stockler, Cristina Suarez, Jemima Thompson, Nat Thorogood, Balaji Venugopal, Mahesh K B Parmar
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