A new article in Clinical Investigation highlights the learnings gleaned from monitoring several complex HIV clinical trials in Africa over a 15 year period. The article identifies and provides solutions for the challenges that emerge when designing and implementing clinical trials in a developing nation. The journal is published by Future Science Group.
"The challenges faced in clinical trial design and implementation - such as compliance, language barriers, accessibility of trial sites and costs - can be exaggerated in trials in developing nations," said Stella Bennett, editor of Clinical Investigation. "The lessons presented in this article can be usefully applied to fields such as neglected tropical disease, and in cases such as the recent Ebola crisis, insights into best-practice clinical trial collaborations are invaluable."
The MRC Clinical Trials Unit at University College London has coordinated HIV clinical trials in Africa for almost 15 years. The article authors review the new approaches to monitoring trial data that are now in use, using a combination of on-site and central (database) monitoring. Over time, the team designed tools and templates to supplement trial protocols and help standardize trial processes. They also developed a team of local monitors, who could supplement infrequent visits from the sponsor, and enable monitoring at the required intensity and allowing for capacity building.
"We have learned a lot from monitoring several complex HIV clinical trials in Africa, and hope that others will benefit by learning about our experiences," said Margaret J. Thomason, lead author and researcher at the Medical Research Council Clinical Trials Unit at UCL. "We encourage more trial teams globally to publish their practical observations so that best practice can be improved upon."