TY - JOUR
T1 - Adapting the design of the ongoing RAMPART trial in response to external evidence
T2 - An example for trials which take many years to run and report
AU - Meade, Angela
AU - Frangou, Elena
AU - Choodari-Oskooei, Babak
AU - Larkin, James
AU - Powles, Tom
AU - Stewart, Grant D.
AU - Albiges, Laurence
AU - Bex, Axel
AU - Choueiri, Toni K.
AU - Davis, Ian D.
AU - Eisen, Tim
AU - Fielding, Alison
AU - Gedye, Craig
AU - Harrison, David J.
AU - Kaplan, Rick
AU - Mulhere, Salena
AU - Nathan, Paul
AU - Patel, Grisma
AU - Patel, Jay
AU - Plant, Hannah
AU - Ritchie, Alastair
AU - Rush, Hannah
AU - Shakeshaft, Clare
AU - Stockler, Martin R.
AU - Suarez, Cristina
AU - Thompson, Jemima
AU - Thorogood, Nat
AU - Venugopal, Balaji
AU - Parmar, Mahesh K.B.
N1 - Publisher Copyright:
© 2024 The Authors
PY - 2024/12/1
Y1 - 2024/12/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85207952581&partnerID=8YFLogxK
U2 - 10.1016/j.conctc.2024.101381
DO - 10.1016/j.conctc.2024.101381
M3 - Article
AN - SCOPUS:85207952581
SN - 2451-8654
VL - 42
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
M1 - 101381
ER -