A training curriculum for clinical trial data sharing
REPRODUCIBILITY IN THERAPEUTIC RESEARCH
ReiTheR is a meta-research project funded by the Agence Nationale de la Recherche (reference number ANR-17-CE-36-0010-01). Some ancillary projects were supported by Région Bretagne and Fondation pour la Recherche Médicale and are also presented on this website. The group now collaborates with the Committee for Open Science to develop clinical trial data sharing plans. A new project is funded by the French Ministry of Health (Programme Hospitalier de Recherche Clinique: Esketamine for “treatment resistant depression”: an Individual Patient Data Meta-analysis: ESK-T-Dep).
HIGHLIGHTS
In this section, we present the main results and implications of the ReITheR project. However, this is only a small part of our results, which you can consult in the research section.
A training curriculum for clinical trial data sharing
A new policy forum "Implementing clinical trial data sharing requires training a new generation of biomedical researchers" is out in Nature Medicine. It proposes an agenda that aims to train a new generation of experts for clinical trial data sharing.
A research agenda for clinical trial data sharing
The ReiTheR project outputs can help to define new policies for medical journals: our policy forum "Medical journal requirements for clinical trial data sharing: ripe for improvement" is now out in PLOS Medicine. It proposes an agenda that aims to reform medical journal requirements for clinical trial data sharing.
10 (not so) simple rules
In PLOS computational biology, we propose 10 (not so) simple 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.
A registered report
Our first registered report "Data-sharing and re-analysis for main studies assessed by the European Medicines Agency—a cross-sectional study on European Public Assessment Reports" is now out in BMC Medicine. With the ReITheR project we are studying features associated with reproducibility. + We try to adopt best standards for reproducible science: registered reports represent such a promising standard and we are pleased to have used this new publication format.
Essay challenge winner !
Our essay "An open science pathway for drug marketing authorization -Registered drug approval" won the "Reimagine Biomedical Research for a Healthier Future Essay Challenge" sponsored by the Health Research Alliance and PLOS.
Making data sharing the norm in medical research
Reuse of medical research data—which is conditional on access to individual participant data—is expected to maximise the value of medical research. Our new editorial "Making data sharing the norm in medical research" is out in The BMJ.
IMPROVING THE TRANSPARENCY AND RELIABILITY OF OBSERVATIONAL STUDIES THROUGH REGISTRATION
Routine registration of observational research is needed and we suggest how current processes can be adapted to facilitate it. Our analysis piece "Improving the transparency and reliability of observational studies through registration" is out in The BMJ.
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CONTACT
Interested in our research ? To learn more please contact us.
ReITheR / Florian Naudet
Inserm CIC 1414
22 Rue Henri le Guilloux
35000 Rennes