Clinical trial reporting workshop – Get ready now to meet tomorrow’s transparency requirements

Das QUEST Center veranstaltet am 26.09.2019 einen Workshop zum Thema "Clinical trial reporting – Get ready now to meet tomorrow’s transparency requirements". Ziel des Workshops ist es, gemeinsam mit Expert*innen aus Großbritannien, Best Practises in der Betreuung von von Einträgen in klinischen Studienregistern zu erarbeiten. Ein besonderer Fokus liegt auf dem Hochladen von Summary Results und Institutsrichtlinien. Die Veranstaltung richtet sich an Verantwortliche für Studienregistereinträge an deutschen Universitätskliniken und affiliierten Koordinierungszentren für Klinische Studien. Weitere Informationen finden Sie untenstehend in englischer Sprache.

The Workshop aims to improve clinical trial registration and summary results posting at German University Medical Centres in both the short and long term.

Background

  • Penalties for failing to post clinical trial summary results onto registries likely come into force 2020+
  • Growing expectations for best practice registration and reporting from research funders, patients, and advocacy groups
  • Growing media attention on the issue, driven by public data and regular performance rankings
  • Expectations are evolving rapidly, but putting into place appropriate policies, systems and processes that improve performance takes time, so the process needs to start now
  • Some university medical centres in the UK have increased summary results reporting rates significantly over the past year. UK experts directly involved in that process will share lessons learned from this process.
  • Participating experts: Tracy Petrie (University of Dundee), Jackie Pullen (Kings College London) & Birgit Whitman (University of Birmingham)


Background reading


Who should join?

  • Staff working at German academic institutions conducting clinical trials who are, or in future are likely to be, overseeing and/or managing clinical trial registry entries
  • Clinical Trial Unit (CTU) management staff, university Research Governance (RG) staff
  • Preference will be given to applicants from institutions sponsoring a large number of trials


Format

  • Knowledge transfer from highly experienced UK trial registry managers
  • Emphasis on peer learning and best practice exchanges in small groups
  • Hands-on workshop focusing on how to overcome practical challenges with limited resources


At the end of the workshop, participants will

  • Understand legal and regulatory requirements, and global best practices, for trial registration and summary results reporting on trial registries
  • Know how to develop effective policies and design efficient processes at minimal cost
  • Be aware of pitfalls and costly mistakes made by other institutions, and be able to avoid repeating them
  • Be able to generate “quick wins” at their own institutions:
    • put into place simple policies and steps that will make registry management and trial reporting easier in future
    • rapidly improve EU Trials Tracker performance with low effort
  • Be able to start preparing their own institutions to meet tomorrow’s clinical trial transparency and research excellence standards

Program/Agenda

Ergebnisse:

Tips, tricks and tools for universities struggling to get all their clinical trials reported. (in Englisch)