Evidence map›Paper›PMID 39555240›Full record

ArticleContemporary clinical trials communications2024

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 and 19 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03288532 (An International Investigator-led Phase III Multi Arm Multi Stage Multi-centre Randomised Controlled Platform Trial of Adjuvant Therapy in Patients With Resected Primary Renal Cell Carcinoma), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03288532 phase3recruitingnot on this map

An International Investigator-led Phase III Multi Arm Multi Stage Multi-centre Randomised Controlled Platform Trial of Adjuvant Therapy in Patients With Resected Primary Renal Cell Carcinoma (RCC) at High or Intermediate Risk of Relapse

TypeinterventionalSponsorUniversity College, LondonRan2018 to 2034Enrolled1,750ConditionsRenal Cell CarcinomaArmsDurvalumab, Tremelimumab
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors.

Angela MeadeMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK.
Elena FrangouMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK.
Babak Choodari-OskooeiMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK.
James LarkinRoyal Marsden Hospital, Royal Marsden Hospital, 203 Fulham Rd, Chelsea, London, SW3 6JJ, UK.
Tom PowlesSt Bartholomew's Hospital, W Smithfield, London, EC1A 7B, UK.
Grant D StewartUniversity of Cambridge, Department of Surgery, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.
Laurence AlbigesInstitut Gustave Roussy, 114 Rue Edouard Vaillant 94805, Villejuif, France.
Axel BexRoyal Free London NHS Foundation Trust UCL Division of Surgery and Interventional Science, Pond Street, London, NW3 2QG, UK.
Toni K ChoueiriDana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, United States.
Ian D DavisMonash University Eastern Health Clinical School, Level 2, 5 Arnold Street, Box Hill, Victoria, 3128, Australia.
Tim EisenDepartment of Oncology, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge Biomedical Campus, Hill's Road Cambridge, CB2 0QQ, UK.
Alison FieldingMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK.
Craig GedyeFaculty of Health and Medicine, The University of Newcastle, Australia.
David J HarrisonUniversity of St Andrews, North Haugh, St Andrews, KY16 9TF, UK.
Rick KaplanMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK.
Salena MulhereMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK.
Paul NathanMount Vernon Cancer Centre, Rickmansworth Rd, Northwood, HA6 2RN, UK.
Grisma PatelMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK.
Jay PatelMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK.
Hannah PlantMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK.
Alastair RitchieMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK.
Hannah RushMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK.
Clare ShakeshaftMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK.
Martin R StocklerNHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW, 2006, Australia.
Cristina SuarezVall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, 08035, Barcelona, Spain.
Jemima ThompsonMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK.
Nat ThorogoodMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK.
Balaji VenugopalSchool of Cancer Sciences, Beatson Institute, University of Glasgow, G61 1BD, UK.
Mahesh K B ParmarMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London, WC1V 6LJ, UK.

Funding

Medical Research Council MC_UU_00004/09
6 · The paper itself

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.

Identifiers

PMID39555240
PMCPMC11563934

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.