UM Lead helps lay the foundations for effective trial design
UM Lead Professor Grant Stewart has cowritten an article in Contemporary Clinical Trials, entitled 'RAMPART; A Model for a Regulatory-Ready Academic-led Phase III Trial in the Adjuvant Renal Cell Carcinoma Setting', alongside colleagues from UCL and St Bartholomew's Hospital.
RAMPART (Renal Adjuvant MultiPle Arm Randomised Trial) is an international, UK-led trial investigating the addition of immune checkpoint inhibitors after nephrectomy in patients with resected locally advanced RCC. RAMPART is a multi-arm multi-stage (MAMS) platform trial, upon which additional research questions may be addressed over time. The paper highlights key elements of protocol including updates to eligibility criteria to include participants with resected synchronous adrenal metastases as well as adjustments that have been made to support participants and sites in light of the COVID-19 pandemic.
Many new investigational agents have been developed in recent years, most with specific biological targets. This has necessitated looking at different ways to streamline the evaluation of new agents. One solution has been the development of adaptive trial designs and another has been the growth of partnerships between academia and industry with the shared goal of designing and conducting trials as efficiently as possible. This publication outlines the ways in which the RAMPART trial brings together both of these processes in an attempt to improve outcomes for patients with locally advanced renal cell carcinoma (RCC). The paper's authors have shared their experience in order to lay the foundations for an effective trial design and conduct framework and to guide others who may be considering similar collaborations.
To read about TransRAMPART, head here.
With thanks to Dr Angela Meade, Principal Research Fellow at UCL and the lead author of this paper.