Evidence map›Paper›PMID 28764809›Full record

ReviewTrials2017

Barriers to the conduct of randomised clinical trials within all disease areas.

Snezana Djurisic, Ana Rath, Sabrina Gaber, Silvio Garattini, Vittorio Bertele, Sandra-Nadia Ngwabyt, Virginie Hivert, Edmund A M Neugebauer, Martine Laville, Michael Hiesmayr and 4 more

Abstract readReview
In one paragraph

Review in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 78 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 6 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.

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

78 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  9. The Epistemic Policies of Anti-Ageing Medicines in the European Union.Health care analysis : HCA : journal of health philosophy and policy · 2026
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18 more citing papers are in PubMed but not listed here.

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

14 authors.

Snezana DjurisicCopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. sd@ctu.dk.ORCID 0000-0001-8259-8250
Ana RathOrphanet, Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, France.
Sabrina GaberEuropean Clinical Research Infrastructure Network (ECRIN), Paris, France.
Silvio GarattiniIRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
Vittorio BerteleIRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
Sandra-Nadia NgwabytOrphanet, Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, France.
Virginie HivertEURORDIS - Rare Diseases Europe, Paris, France.
Edmund A M NeugebauerBrandenburg Medical School, Neuruppin, and Witten/Herdecke University, Witten, Germany.
Martine LavilleCentre de Recherche en Nutrition Humaine Rhone-Alpes, Université de Lyon 1, Hospices Civils de Lyon, Groupement Hospitaler Sud, Pierre Benite, France.
Michael HiesmayrDivision of Cardiac, Thoracic, Vascular Anaesthesia and Intensive Care, Vienna General Hospital Währinger Gürtel, Vienna, Austria.
Jacques Demotes-MainardEuropean Clinical Research Infrastructure Network (ECRIN), Paris, France.
Christine KubiakEuropean Clinical Research Infrastructure Network (ECRIN), Paris, France.
Janus C JakobsenCopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Christian GluudCopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. cgluud@ctu.dk.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRandomised clinical trials are key to advancing medical knowledge and to enhancing patient care, but major barriers to their conduct exist. The present paper presents some of these barriers.

methodsWe performed systematic literature searches and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project.

resultsThe following barriers to randomised clinical trials were identified: inadequate knowledge of clinical research and trial methodology; lack of funding; excessive monitoring; restrictive privacy law and lack of transparency; complex regulatory requirements; and inadequate infrastructures. There is a need for more pragmatic randomised clinical trials conducted with low risks of systematic and random errors, and multinational cooperation is essential.

conclusionsThe present paper presents major barriers to randomised clinical trials. It also underlines the value of using a pan-European-distributed infrastructure to help investigators overcome barriers for multi-country trials in any disease area.

Indexed as

Research DesignAttitude of Health PersonnelConfidentialityCooperative BehaviorEquipment and SuppliesEuropeEvidence-Based MedicineHealth Knowledge, Attitudes, PracticeHumansMulticenter Studies as TopicNutrition TherapyPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicRare DiseasesResearch PersonnelResearch Support as TopicBarriersBottlenecksChallengesEvidence based clinical practiceEvidence based medicineHindrancesRandomised clinical trials

Identifiers

PMID28764809
PMCPMC5539637

What OpenQuestion holds

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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.