Data Management In Non-Commercial North-South Collaborative Clinical Research : Lessons Learned From Some EDCTP Trials
Abstract accepted as oral presentation, European & Developing Countries Clinical Trials Partnership conference in Addis Ababa, 2011
Harry van Loen(1), Mary Thiongo(2), Anish Bhattarai(3), Hercule Kalonji(i4), Robert Meester(5), David Mwakazanga(6), Sayouba Ouedraogo(7), James Smedley(8), Sok Sopheak(9), Arouna Woukeu(10), Greta Gondol(1), Raffaella Ravinetto(1) and Yves Claeys(1)
(1)Institute of Tropical Medicine (ITM) Prince Leopold, Belgium; (2)International Centre for Reproductive Health, Kenya; (3)BP Koirala Institute of Health Sciences, Nepal; (4)University of Kinshasa, Democratic Republic of Congo;(5)Amsterdam Medical Center, The Netherlands; (6)Tropical Disease Research Centre, Zambia; (7)IRSS/Centre Muraz, Burkina Faso; (8)Liverpool School of Tropical Medicine, UK; (9)Sinahouk Hospital Centre of Hope, Cambodia; (10)London School of Hygiene and and Tropical Medicine, UK.
Introduction: Clinical Data Management (DM) faces many difficulties and challenges. This is especially true in academic environments, where the limited budget generally allows for small DM teams. Nevertheless, these teams have to comply with the same GCP and regulatory standards as the private sector and adapt to progress in medical research and rapid developments in IT. Resource-limited settings can present additional difficulties (e.g. intermittent internet connections).
Methods: A group of Northern and Southern clinical data managers met at the Antwerp Institute of Tropical Medicine in December 2010, to share their knowledge and experience with DM of non-commercial clinical research. In particular, lessons learned from the EDCTP 4-ABC and PREGACT malaria trials, the EDCTP Microbicide Safety Biomarkers trial, as well as other Southern-based studies were shared.
Results: Some challenges were found to be common at the start of projects: late involvement of data managers; workload underestimations and inadequate budget for some activities, e.g. database validation; lack (or handover) of human resources and of solid expertise in validation and programming; heterogeneous use in software and documentation at different sites, and sometimes low internet connectivity and power instability. In addition, finding open access software suitable for multicentre trials remains a challenge.
Conclusions and recommendations: There is a clear case for promoting a North-South collaborative platform of clinical data managers (as it happens among clinical researchers) aiming for good clinical DM practices. Training, the design of common operating procedures and document templates, and the development of a collaborative network are seen as the obvious next steps in meeting these goals.