Registration and reporting of drug trials on humans

The EU is now further tightening the rules and procedures for transparency in drug trials. In 2021, a completely new system will be launched for registration, reporting and follow-up. For a long time now, transparency in drug trials has been inadequate in Sweden and internationally, which has damaged research and its reputation.

The Faculty of Medicine has therefore started a proactive initiative together with Cochrane Sweden to raise awareness of the importance of the registration and reporting of clinical trials, and to ensure that drug trials in Lund are conducted in accordance with ethical and regulatory guidelines.

As part of this work, the Faculty of Medicine and Cochrane Sweden are holding an open webinar about drug trials on 16 June from 13:30-15:30. The seminar will be held in English.

Program

13.30 - 13.40
Welcome
Emma Thompson from Cochrane, and Heiko Herwald Vice-Dean at Faculty of Medicine, Lund University

13.40 - 14.00
“We have come a long way: Data Transparency and Pharmaceutical Regulation Europe”, Shai Mulinari, Dept Sociology, Lund University

14.00 - 14.20
“Getting all clinical trial results reported - lessons learnt from successful universities”,Till Bruckner, author of a clinical trial reporting manual for universities. He is a Research Fellow at the BIH QUEST Center and the founder of the TranspariMED campaign

BREAK

14.30 - 14.50
“Centralizing the Clinical Trial Registration and Results Reporting Process in Academic Institutions”, Tony Durkee, Lead Coordinator for Clinical Trials at the Compliance and Data Office (CDO) at Karolinska Institutet

14.50 - 15.10
“Clinical Trial Registering and Reporting”, Maria Skoog, Clinical trial manager, Clinical study support, Clinical Studies Sweden - Forum South

15.10 - 15.30
Q & A session moderated by Emma Thompson

Registration:

• https://lu-se.zoom.us/webinar/register/WN_Ols44T6lQ--N7DQdYw84_g