Evidence map›Paper›PMID 36893146›Full record

ReviewPLoS computational biology2023

Ten (not so) simple rules for clinical trial data-sharing.

Claude Pellen, Anne Le Louarn, Gilliosa Spurrier-Bernard, Evelyne Decullier, Jean-Marie Chrétien, Eric Rosenthal, Gérard Le Goff, David Moher, John P A Ioannidis, Florian Naudet

Abstract readReview
In one paragraph

Review in PLoS computational biology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Article
  6. 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

10 authors.

Claude PellenUniv Rennes, CHU Rennes, Inserm, Irset (Institut de recherche en santé, environnement et travail)-UMR_S 1085, CIC 1414 [(Centre d'Investigation Clinique de Rennes)], Rennes, France.ORCID 0000-0001-8712-0766
Anne Le LouarnGCS CNCR (Comité National de Coordination de la Recherche), Paris, France.
Gilliosa Spurrier-BernardMelanomeFrance, Teilhet, France.
Evelyne DecullierHospices Civils de Lyon, Pôle Santé Publique, Service REC, Lyon, France.
Jean-Marie ChrétienCHU Angers, DRI-Département Science de la Donnée, Angers, France.
Eric RosenthalANRS|Maladies infectieuses émergentes, PariSanté Campus, Paris, France.
Gérard Le GoffFrance Rein Bretagne, Laillé, France.
David MoherCentre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
John P A IoannidisDepartments of Medicine, Epidemiology and Population Health, Biomedical Data Science, and Statistics, and Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, United States of America.
Florian NaudetUniv Rennes, CHU Rennes, Inserm, Irset (Institut de recherche en santé, environnement et travail)-UMR_S 1085, CIC 1414 [(Centre d'Investigation Clinique de Rennes)], Rennes, France.ORCID 0000-0003-3760-3801

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Clinical trial data-sharing is seen as an imperative for research integrity and is becoming increasingly encouraged or even required by funders, journals, and other stakeholders. However, early experiences with data-sharing have been disappointing because they are not always conducted properly. Health data is indeed sensitive and not always easy to share in a responsible way. We propose 10 rules for researchers wishing to share their data. These rules cover the majority of elements to be considered in order to start the commendable process of clinical trial data-sharing: Rule 1: Abide by local legal and regulatory data protection requirementsRule 2: Anticipate the possibility of clinical trial data-sharing before obtaining fundingRule 3: Declare your intent to share data in the registration stepRule 4: Involve research participantsRule 5: Determine the method of data accessRule 6: Remember there are several other elements to shareRule 7: Do not proceed aloneRule 8: Deploy optimal data management to ensure that the data shared is usefulRule 9: Minimize risksRule 10: Strive for excellence.

Indexed as

Information DisseminationRecordsHumansResearch Personnel

Identifiers

PMID36893146
PMCPMC9997951

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.