Menu
MapConnectionsTopicsBulgariaThe Night (K-TRIO)Marie Skłodowska-CurieFor studentsFor teachersMethodologySurprise me
HEDoctoral network2024–2027

SHARE-CTD · Sharing and re-using clinical trial data to maximise impact

Horizon Europe — Marie Skłodowska-Curie Actions

Duration
2024-01-01 → 2027-12-31
EU contribution
€2,694,377
Participants
24
Scheme
HORIZON-TMA-MSCA-DN

Lines connect the coordinator with its partners.

Results in brief

Sharing and re-using clinical trial data to maximise impact

Clinical trial data sharing is important for trustworthy and efficient health research. When trial data can be shared responsibly, study results can be checked independently, research questions can be revisited, and evidence can be reused for the benefit of patients and society. Clinical trial data sharing is crucial part of securing clinical trial integrity. At the same time, any sharing must respect privacy, consent, and legitimate confidentiality concerns. Sharing should contribute to create positive value for the society. SHARE-CTD responds to this challenge by training doctoral researchers and developing practical solutions for the responsible access, sharing, and reuse of clinical trial data. By bringing together universities, hospitals, infrastructure providers, patient perspectives, regulators, academic research funders, and industry partners, the project aims to improve access to trial information, support timely communication of results, and strengthen high-quality data-sharing practice across Europe.

Data: CORDIS, © European Union

Project objective

Data from clinical trials are a rich source of clinical information, highly structured and clearly explained by the accompanying protocols. Responsible sharing of such data holds incredible promises to increase value and decrease waste in medical research. It is built on principles (ethical, scientific), governance structures, skills, and operation infrastructure. Clinical trial data sharing (CTDS) is an emerging activity in academia as well as in the pharmaceutical industry. Both communities develop models for organising and performing CTDS. Thereby, several issues gain relevance: enhancing data sharing with researchers, improving public access to clinical study information, sharing results with patients participating in clinical trials, certifying procedures for sharing clinical trial information, and reaffirming commitments to publish clinical trial results. We see a developing field of professional activities that need well educated experts to define and implement best practices. Training such a new generation of experts in CTDS requires specific teachings with a focus on clinical trial transparency and reproducible research practices. It should include topics such as clinical trials regulations, ethical, legal, and social issues, informatics, data science, biostatistics, and meta-research, as well as domain expertise across different medical fields. In order to gain a deep understanding of this developing field, research activities should be based on meta-research approaches. Those activities focus on research on best practices for CTDS, developing methods to make efficient use of shared data (e.g., methods to augment randomised clinical trials, perform independent participant data meta-analysis, or estimate personalised treatment effects) and measuring CTDS impact.

Original text from CORDIS.

Participants

  • LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN · PlaneggCoordinatorGermany
  • BAYER AKTIENGESELLSCHAFT · LeverkusenGermany
  • BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIVERSITY · STANFORDUnited States
  • CHARITE - UNIVERSITAETSMEDIZIN BERLIN · BerlinGermany
  • DEUTSCHE ZENTRALBIBLIOTHEK FUR MEDIZIN (ZB MED)-LEIBNIZ-INFORMATIONSZENTRUM LEBENSWISSENSCHAFTEN · COLOGNEGermany
  • DEUTSCHES INSTITUT FUER ERNAEHRUNGSFORSCHUNG POTSDAM REHBRUECKE · NuthetalGermany
  • ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK · ParisFrance
  • GEORG-AUGUST-UNIVERSITAT GOTTINGEN STIFTUNG OFFENTLICHEN RECHTS · GottingenGermany
  • HOSPICES CIVILS DE LYON · LyonFrance
  • INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE · ParisFrance
  • MEDIZINISCHE UNIVERSITAET WIEN · WienAustria
  • NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE · ManchesterUnited Kingdom
  • OTTAWA HOSPITAL RESEARCH INSTITUTE CORPORATION · Ottawa OntarioCanada
  • SciCrunch Inc · San DiegoUnited States
  • Smart Data Analysis and Statistics B.V. · UtrechtNetherlands
  • UNIVERSITA DEGLI STUDI DI PADOVA · PadovaItaly
  • UNIVERSITAETSMEDIZIN GOETTINGEN - GEORG-AUGUST-UNIVERSITAET GOETTINGEN - STIFTUNG OEFFENTLICHEN RECHTS · GoettingenGermany
  • UNIVERSITAIR MEDISCH CENTRUM UTRECHT · UtrechtNetherlands
  • UNIVERSITAT ZURICH · ZurichSwitzerland
  • UNIVERSITE DE RENNES · RennesFrance
  • UNIVERSITE LYON 1 CLAUDE BERNARD · Villeurbanne CedexFrance
  • UNIVERSITEIT UTRECHT · UtrechtNetherlands
  • VERENIGING VOOR CHRISTELIJK HOGER ONDERWIJS WETENSCHAPPELIJK ONDERZOEK EN PATIENTENZORG · AmsterdamNetherlands
  • YALE UNIVERSITY · New HavenUnited States

Links

Data: CORDIS, © European Union