Evidence map›Paper›PMID 34538401›Full record

ArticleContemporary clinical trials2021

RAMPART: A model for a regulatory-ready academic-led phase III trial in the adjuvant renal cell carcinoma setting.

Angela Meade, Bhavna Oza, Eleni Frangou, Ben Smith, Hanna Bryant, Rick Kaplan, Babak Choodari-Oskooei, Tom Powles, Grant D Stewart, Laurence Albiges and 17 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2021. 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 34% of its field
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

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
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

27 authors at 15 institutions in 5 countries.

Angela MeadeMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ.
Bhavna OzaMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ. Electronic address: b.oza@ucl.ac.uk.
Eleni FrangouMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ.
Ben SmithMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ.
Hanna BryantMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ.
Rick KaplanMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ.
Babak Choodari-OskooeiMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ.
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; The Netherlands Cancer Institute, Amsterdam, The Netherlands.
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, VIC 3128, Australia; Department of Medical Oncology, Eastern Health, Melbourne, Australia; ANZUP Cancer Trials Group, Sydney, 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.
David J HarrisonUniversity of St Andrews, North Haugh, St Andrews, KY16 9TF, UK.
Anita McWhirterRoyal Marsden Hospital, Royal Marsden Hospital, 203 Fulham Rd, Chelsea, London SW3 6JJ, UK.
Salena MulhereMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ.
Paul NathanMount Vernon Cancer Centre, Rickmansworth Rd, Northwood HA6 2RN, UK.
Brian RiniCleveland Clinic, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA.
Alastair RitchieMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ.
Sarah ScovellSt Bartholomew's Hospital, W Smithfield, London EC1A 7B, UK.
Clare ShakeshaftMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ.
Martin R StocklerANZUP Cancer Trials Group, Sydney, Australia; NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW 2006, Australia.
Nat ThorogoodMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ.
James LarkinRoyal Marsden Hospital, Royal Marsden Hospital, 203 Fulham Rd, Chelsea, London SW3 6JJ, UK.
Mahesh K B ParmarMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, 2nd Floor 90 High Holborn, London WC1V 6LJ.
MRC Clinical Trials Unit at UCL · GBUniversity College London · GBSt Bartholomew's Hospital · GBCambridge University Hospitals NHS Foundation Trust · GBCleveland Clinic · USDana-Farber Cancer Institute · USInstitut Gustave Roussy · FRMonash University · AUMount Vernon Cancer Centre · GBNational Health and Medical Research Council · AURoyal Marsden Hospital · GBRoyal Marsden NHS Foundation Trust · GBThe Netherlands Cancer Institute · NLUniversity of Cambridge · GBUniversity of St Andrews · GB

Funding

Cancer Research UK 28690Medical Research Council MC_UU_00004/01Medical Research Council MC_UU_00004/08Medical Research Council MC_UU_00004/09Medical Research Council MC_UU_12023/24Medical Research Council MC_UU_12023/29
6 · The paper itself

Abstract

The development of therapeutics in oncology is a highly active research area for the pharmaceutical and biotechnology industries, but also has a strong academic base. Many new agents have been developed in recent years, most with specific biological targets. This has mandated the need to look at different ways to streamline the evaluation of new agents. One solution has been the development of adaptive trial designs that allow the evaluation of multiple agents, concentrating on the most promising agents while screening out those which are unlikely to benefit patients. Another way forward has been the growth of partnerships between academia and industry with the shared goal of designing and conducting high quality clinical trials which answer important clinical questions as efficiently as possible. The RAMPART trial (NCT03288532) brings together both of these processes in an attempt to improve outcomes for patients with locally advanced renal cell carcinoma (RCC), where no globally acceptable adjuvant strategy after nephrectomy currently exist. RAMPART is led by the MRC CTU at University College London (UCL), in collaboration with other international academic groups and industry. We aim to facilitate the use of data from RAMPART, (dependent on outcomes), for a future regulatory submission that will extend the license of the agents being investigated. We share our 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. Trial Registration: ISRCTN #: ISRCTN53348826, NCT #: NCT03288532, EUDRACT #: 2017-002329-39. CTA #: 20363/0380/001-0001. MREC #: 17/LO/1875. ClinicalTrials.gov Identifier: NCT03288532 RAMPART grant number: MC_UU_12023/25. . RAMPART Protocol version 5.0.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsAdaptive Clinical Trials as TopicClinical Trials, Phase III as TopicHumansLondonDurvalumabMAMSPlatform trialRAMPARTRenal cancerTremelimumab

Identifiers

PMID34538401
PMCPMC7616459
OpenAlexW3199995424

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.