Evidence map›Paper›PMID 36434156›Full record

ArticleBritish journal of cancer2023

Additional consensus recommendations for conducting complex innovative trials of oncology agents: a post-pandemic perspective.

Sarah P Blagden, Ly-Mee Yu, Stephanie Ellis, Helen Hughes, Abeer Shaaban, Jonathan Fennelly-Barnwell, Mark P Lythgoe, Alison M Cooper, Francois M Maignen, Sean W Buckland and 3 more

Open access · hybridAbstract readConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Article in British journal of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.3field-weighted citation impact, top 25% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

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

13 authors at 9 institutions in 1 country.

Sarah P BlagdenDepartment of Oncology, Old Road Campus Research Building, University of Oxford, Oxford, UK. sarah.blagden@oncology.ox.ac.uk.ORCID http://orcid.org/0000-0001-8783-3491
Ly-Mee YuPrimary Care Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Stephanie EllisLondon Hampstead Research Ethics Committee, Health Research Authority, Elephant and Castle, London, UK.
Helen HughesCardiff and Vale University Local Health Board, University Hospital of Wales, Cardiff, UK.
Abeer ShaabanQueen Elizabeth Hospital Birmingham and the University of Birmingham, Birmingham, UK.ORCID http://orcid.org/0000-0001-5784-8705
Jonathan Fennelly-BarnwellLondon Hampstead Research Ethics Committee, Health Research Authority, Elephant and Castle, London, UK.
Mark P LythgoeImperial College London, Hammersmith Hospital, Du Cane Road, London, UK.ORCID http://orcid.org/0000-0002-8952-7639
Alison M CooperThe Association of the British Pharmaceutical Industry, London, UK.
Francois M MaignenNational Institute for Health and Care Excellence (NICE), London, UK.
Sean W BucklandPfizer Ltd, Walton Oaks, Tadworth, Surrey, UK.
Pamela R KearnsCancer Research UK Clinical Trials Unit, NIHR Birmingham Biomedical Research Centre, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
Louise C BrownMRC Clinical Trials Unit at University College London, 90 High Holborn, London, UK.
Experimental Cancer Medicine Centres (ECMC) CID trials working group
University of Oxford · GBAssociation of the British Pharmaceutical Industry · GBCancer Research UK Clinical Trials Unit · GBCardiff and Vale University Health Board · GBHammersmith Hospital · GBMRC Clinical Trials Unit at UCL · GBNational Institute for Health and Care Excellence · GBPfizer (United Kingdom) · GBQueen Elizabeth Hospital Birmingham · GB

Funding

Cancer Research UK 25354Medical Research Council MC_UU_00004/01Medical Research Council MC_UU_00004/02Medical Research Council MC_UU_00004/08Medical Research Council MC_UU_12023/20Medical Research Council MC_UU_12023/24
6 · The paper itself

Abstract

In our 2020 consensus paper, we devised ten recommendations for conducting Complex Innovative Design (CID) trials to evaluate cancer drugs. Within weeks of its publication, the UK was hit by the first wave of the SARS-CoV-2 pandemic. Large CID trials were prioritised to compare the efficacy of new and repurposed COVID-19 treatments and inform regulatory decisions. The unusual circumstances of the pandemic meant studies such as RECOVERY were opened almost immediately and recruited record numbers of participants. However, trial teams were required to make concessions and adaptations to these studies to ensure recruitment was rapid and broad. As these are relevant to cancer trials that enrol patients with similar risk factors, we have added three new recommendations to our original ten: employing pragmatism such as using focused information sheets and collection of only the most relevant data; minimising negative environmental impacts with paperless systems; and using direct-to-patient communication methods to improve uptake. These recommendations can be applied to all oncology CID trials to improve their inclusivity, uptake and efficiency. Above all, the success of CID studies during the COVID-19 pandemic underscores their efficacy as tools for rapid treatment evaluation.

Indexed as

COVID-19HumansMedical OncologyPandemicsSARS-CoV-2

Identifiers

PMID36434156
PMCPMC9702707
OpenAlexW4310058959

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.