PS4-1 : Good Clinical Practices guidelines in the context of globalized clinical research: need for a revision?

PS4-1 : Good Clinical Practices guidelines in the context of globalized clinical research: need for a revision?

Parallels
Location: Room 18 Date: April 19, 2016 Time: 11:00 am - 12:30 pm

Background

The Good Clinical Practices (GCP) Guidelines of the World Health Organisation (WHO) and those of the International Conference of Harmonization (ICH) are meant to set globally applicable standards for trials’ conduct. But more and more trials are conducted today in low- and middle-income countries, where researchers face challenges that are not anticipated or considered in the current WHO and ICH Guidelines. The gap between the international GCP Guidelines and the reality in the field has been highlighted in recent years by various research groups (White 2006; Lang 2011; Reith 2013). The ICH have recently started a process of update of their GCP guidelines, whose process has already been challenged. Many suggest that there is an urgent need to advocate for a revision of the international GCP codes

 

General objective

The objective of this session is to discuss the gaps of the international GCP codes in light of the new scenarios of globalized clinical research and, if appropriate, to trigger advocacy for a GCP revision

 

ID Name of the moderator Organisation Country
PS4-1/0 Ravinetto Raffaella IMT Antwerp Belgium

Presentations:

ID Title of the presentation Name of the speaker Organisation Country
PS4-1/1 The Globalization of Clinical Trials and the Urgent Need to Update the International GCP Codes Laura Ciaffi IRD Cameroon
PS4-1/2 Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines Marleen Boelaert IMT Antwerp Belgium
PS4-1/3 Need for Training and Recognition of new Professional Roles for Health Personnel Involved in Clinical Research Sylvie Le Gac ANRS Cameroon
PS4-1/4 Round Table TDR Switzerland
PS4-1/5 Round Table Nerina Vischer Swiss TPH Switzerland
PS4-1/6 Round Table

EDCTP

Netherlands

PS4-1/7 Round Table

Clinical Trial Unit, Geneva Uni- versity Hospitals

Switzerland