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
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 p...
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| Format: | Article |
| Language: | English |
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Elsevier
2024-12-01
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| Series: | Contemporary Clinical Trials Communications |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865424001285 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Angela Meade |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-152a532dd63f4c618fd32817ead311e1 |
| institution | Kabale University |
| issn | 2451-8654 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj-art-152a532dd63f4c618fd32817ead311e12024-12-18T08:49:55ZengElsevierContemporary Clinical Trials Communications2451-86542024-12-0142101381Adapting the design of the ongoing RAMPART trial in response to external evidence: An example for trials which take many years to run and reportAngela Meade0Elena Frangou1Babak Choodari-Oskooei2James Larkin3Tom Powles4Grant D. Stewart5Laurence Albiges6Axel Bex7Toni K. Choueiri8Ian D. Davis9Tim Eisen10Alison Fielding11Craig Gedye12David J. Harrison13Rick Kaplan14Salena Mulhere15Paul Nathan16Grisma Patel17Jay Patel18Hannah Plant19Alastair Ritchie20Hannah Rush21Clare Shakeshaft22Martin R. Stockler23Cristina Suarez24Jemima Thompson25Nat Thorogood26Balaji Venugopal27Mahesh K.B. Parmar28MRC 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.MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UKRoyal Marsden Hospital, Royal Marsden Hospital, 203 Fulham Rd, Chelsea, London, SW3 6JJ, UKSt Bartholomew's Hospital, W Smithfield, London, EC1A 7B, UKUniversity of Cambridge, Department of Surgery, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UKInstitut Gustave Roussy, 114 Rue Edouard Vaillant 94805, Villejuif, FranceRoyal Free London NHS Foundation Trust UCL Division of Surgery and Interventional Science, Pond Street, London, NW3 2QG, UK; Netherlands Cancer Institute, Amsterdam, the NetherlandsDana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, United StatesMonash University Eastern Health Clinical School, Level 2, 5 Arnold Street, Box Hill, Victoria, 3128, Australia; Department of Medical Oncology, Eastern Health, Melbourne, AustraliaDepartment of Oncology, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge Biomedical Campus, Hill's Road Cambridge, CB2 0QQ, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UKFaculty of Health and Medicine, The University of Newcastle, AustraliaUniversity of St Andrews, North Haugh, St Andrews, KY16 9TF, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UKMount Vernon Cancer Centre, Rickmansworth Rd, Northwood, HA6 2RN, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UKNHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW, 2006, Australia; ANZUP Cancer Trials Group, Sydney, AustraliaVall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, 08035, Barcelona, SpainMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UKSchool of Cancer Sciences, Beatson Institute, University of Glasgow, G61 1BD, UKMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UKClinical 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.http://www.sciencedirect.com/science/article/pii/S2451865424001285 |
| spellingShingle | 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 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 Contemporary Clinical Trials Communications |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | http://www.sciencedirect.com/science/article/pii/S2451865424001285 |
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