Evidence map›Paper›PMID 28329235›Full record

ArticleEuropean heart journal2017

Improving public health by improving clinical trial guidelines and their application.

Martin J Landray, Jeroen J Bax, Laurence Alliot, Marc Buyse, Adam Cohen, Rory Collins, Gerhard Hindricks, Stefan K James, Sile Lane, Aldo P Maggioni and 15 more

Abstract read
In one paragraph

Article in European heart journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–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.

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

12 citing papers in PubMed.

  1. Article
  2. Article
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  5. Article
  6. Article
  7. Article
  8. Review
  9. Review
  10. Ethical review of patient safety and public health in EU clinical trials legislation: impact of COVID-19 pandemic.Romanian journal of morphology and embryology = Revue roumaine de morphologie et embryologie · 2020
    Article
  11. Article
  12. 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

25 authors.

Martin J LandrayClinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Jeroen J BaxDepartment of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Laurence AlliotServier, Paris, France.
Marc BuyseIDDI and CluePoints, Louvain-la-Neuve, Belgium.
Adam CohenCentre for Human Drug Research, Leiden, The Netherlands.
Rory CollinsClinical Trial Service Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Gerhard HindricksDepartment of Electrophysiology, Heart Center, University of Leipzig, Leipzig, Germany.
Stefan K JamesDepartment of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
Sile LaneSense About Science, London, UK.
Aldo P MaggioniANMCO Research Center, Florence, Italy.
Ann Meeker-O'ConnellJohnson & Johnson, New Brunswick, New Jersey, USA.
Gunnar OlssonBoard Member (advisory) of European Society of Cardiology, Sweden.
Stuart J PocockDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
Michael RawlinsMedicines and Healthcare products Regulatory Agency, London, UK.
Jonathan SellorsLLP, Howard Kennedy, London, UK.
Kaori ShinagawaPharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Karin R SipidoDepartment of Cardiovascular Sciences, Experimental Cardiology, KU Leuven, University of Leuven, Leuven, Belgium.
Liam SmeethDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
Richard StephensConsumer Lead, National Cancer Research Institute, London, UK.
Murray W StewartGlaxoSmithKline, Philadelphia, PA, USA.
Wendy Gattis StoughCampbell University College of Pharmacy and Health Sciences, North Carolina, USA.
Fergus SweeneyEuropean Medicines Agency, London, UK.
Frans Van de WerfDepartment of Cardiovascular Sciences, University Hospitals, Leuven, Belgium.
Kerrie WoodsNational Institute for Health Research, National Health Service, London, UK.
Barbara CasadeiRadcliffe Department of Medicine, Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford, Level 6, West Wing, Oxford, OX3 9DU, UK.

Funding

British Heart Foundation RG/11/15/29375Department of Health HTA/14/49/159Medical Research Council MC_UU_12026/4Wellcome Trust
6 · The paper itself

Abstract

Evidence generated from randomized controlled trials forms the foundation of cardiovascular therapeutics and has led to the adoption of numerous drugs and devices that prolong survival and reduce morbidity, as well as the avoidance of interventions that have been shown to be ineffective or even unsafe. Many aspects of cardiovascular research have evolved considerably since the first randomized trials in cardiology were conducted. In order to be large enough to provide reliable evidence about effects on major outcomes, cardiovascular trials may now involve thousands of patients recruited from hundreds of clinical sites in many different countries. Costly infrastructure has developed to meet the increasingly complex organizational and operational requirements of these clinical trials. Concerns have been raised that this approach is unsustainable, inhibiting the reliable evaluation of new and existing treatments, to the detriment of patient care. These issues were considered by patients, regulators, funders, and trialists at a meeting of the European Society of Cardiology Cardiovascular Roundtable in October 2015. This paper summarizes the key insights and discussions from the workshop, highlights subsequent progress, and identifies next steps to produce meaningful change in the conduct of cardiovascular clinical research.

Indexed as

Practice Guidelines as TopicCardiologyDiffusion of InnovationDisclosureHumansInformed ConsentPatient SafetyPublic HealthQuality Assurance, Health CareRandomized Controlled Trials as TopicRisk AssessmentCardiovascular diseasesClinical trialsPragmatic clinical trialsRandomized controlled trials

Identifiers

PMID28329235
PMCPMC5837481

What OpenQuestion holds

Textmetadata
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.