Contemporary Clinical Trials Communications (Dec 2024)
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
- 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
Affiliations
- Angela Meade
- MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK; Corresponding author. Medical Research Council, Clinical Trials Unit at University College London, 90 High Holborn, London, WC1V 6LJ, UK.
- Elena Frangou
- MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK
- Babak Choodari-Oskooei
- MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK
- James Larkin
- Royal Marsden Hospital, Royal Marsden Hospital, 203 Fulham Rd, Chelsea, London, SW3 6JJ, UK
- Tom Powles
- St Bartholomew's Hospital, W Smithfield, London, EC1A 7B, UK
- Grant D. Stewart
- University of Cambridge, Department of Surgery, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK
- Laurence Albiges
- Institut Gustave Roussy, 114 Rue Edouard Vaillant 94805, Villejuif, France
- Axel Bex
- Royal Free London NHS Foundation Trust UCL Division of Surgery and Interventional Science, Pond Street, London, NW3 2QG, UK; Netherlands Cancer Institute, Amsterdam, the Netherlands
- Toni K. Choueiri
- Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, United States
- Ian D. Davis
- Monash University Eastern Health Clinical School, Level 2, 5 Arnold Street, Box Hill, Victoria, 3128, Australia; Department of Medical Oncology, Eastern Health, Melbourne, Australia
- Tim Eisen
- Department of Oncology, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge Biomedical Campus, Hill's Road Cambridge, CB2 0QQ, UK
- Alison Fielding
- MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK
- Craig Gedye
- Faculty of Health and Medicine, The University of Newcastle, Australia
- David J. Harrison
- University of St Andrews, North Haugh, St Andrews, KY16 9TF, UK
- Rick Kaplan
- MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK
- Salena Mulhere
- MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK
- Paul Nathan
- Mount Vernon Cancer Centre, Rickmansworth Rd, Northwood, HA6 2RN, UK
- Grisma Patel
- MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK
- Jay Patel
- MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK
- Hannah Plant
- MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK
- Alastair Ritchie
- MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK
- Hannah Rush
- MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK
- Clare Shakeshaft
- MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK
- Martin R. Stockler
- NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW, 2006, Australia; ANZUP Cancer Trials Group, Sydney, Australia
- Cristina Suarez
- Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, 08035, Barcelona, Spain
- Jemima Thompson
- MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK
- Nat Thorogood
- MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK
- Balaji Venugopal
- School of Cancer Sciences, Beatson Institute, University of Glasgow, G61 1BD, UK
- Mahesh K.B. Parmar
- MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK
- Journal volume & issue
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Vol. 42
p. 101381
Abstract
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.
