2026-04-14T04:09:46Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/123902025-05-04T15:12:45Zcom_2072_378072com_2072_378040col_2072_378100

Adapting the design of the ongoing RAMPART trial in response to external evidence: An example for trials which take many years to run and report Meade, Angela Frangou, Elena Choodari-Oskooei, Babak Stewart, Grant D. Larkin, James Powles, Thomas Suárez, Cristina Ronyons - Càncer - Immunoteràpia Medicaments antineoplàstics - Ús terapèutic Medicaments - Assaigs clínics ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics::Clinical Studies as Topic::Clinical Trials as Topic CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents::Antineoplastic Agents, Immunological DISEASES::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Urologic Neoplasms::Kidney Neoplasms Other subheadings::Other subheadings::Other subheadings::/drug therapy TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::métodos epidemiológicos::características de los estudios epidemiológicos::estudios clínicos como asunto::ensayos clínicos como asunto COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos::inmunoterapia antineoplásica ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias urológicas::neoplasias renales Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia Diseño de ensayo clínico; Cáncer renal; Terapia con inhibidores de puntos de control inmunitario Disseny d'assaig clínic; Càncer renal; Teràpia amb inhibidors de punts de control immunitari Clinical trial design; Renal cancer; Immune checkpoint inhibitor therapy 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. 2025-01-09T11:32:59Z 2025-01-09T11:32:59Z 2024-12 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Contemporary Clinical Trials Communications;42 https://doi.org/10.1016/j.conctc.2024.101381 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess Elsevier Scientia