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Background

Most universities in the EU (including the Charité - Universitätsmedizin Berlin) are currently failing to upload clinical trial results onto registries, leading to research waste and incomplete outcome reporting.

Universities and other non-commercial trial sponsors in Germany and other EU countries are increasingly becoming aware of their obligation to upload the results of clinical trials onto the European trial registry EudraCT. Pressure to do this will increase with continued advocacy by campaign groups and the coming into force of the EU Clinical Trial Regulation in late 2020 or early 2021.

However, universities are often unclear about how to (a) upload the results of old trials, and (b) set up systems that ensure timely results posting going forward. This creates a barrier to improved performance.

Aims

The aim of the project is to draw together the experiences and lessons learnt by front-runner universities that have successfully tackled the problem, and develop a hands-on manual for other universities that wish to do the same. The manual will focus on steps taken at the institutional level; it will not contain a guide to using EudraCT.

Methods

  • Interviews with registry managers at advanced universities (started Dec 2019)
  • Drafting of the manual
  • Peer review of the draft by experienced registry managers
  • Publication and dissemination of manual

Deliverables

1 manual - The manual is now available here.
Dissemination of manual via blogs, direct outreach and possibly (TBD) workshops.

  • Prof. Dr. Dr. Daniel Strech

    AG Leiter | Stellvertretender Direktor QUEST Center

    Kontaktinformationen
    Telefon:+49 30 450 543 068
    E-Mail:daniel.strech@bihealth.de
  • Dr. Till Brückner

    Wissenschaftlicher Mitarbeiter

    Kontaktinformationen
    Telefon:+49 30 450 543 068
    E-Mail:till.brueckner@charite.de