Challenges of non‐commercial multicentre North‐South collaborative clinical trials

Abstract

The last decade has witnessed a substantial increase of multi-centre, public health-oriented clinical trials in poor countries. However, non-commercial research groups have less staff and financial resources than traditional commercial sponsors, so the trial teams have to be creative to comply with Good Clinical Practices (GCP) requirements. According to the recent experience of a large multicentre trial on antimalarials, major challenges result from the complexity of multiple ethical review, the costs of in-depth monitoring at several sites, setting up an adequate Good Clinical Laboratory Practices (GCLP) framework, lack of insurers in host countries, and lack of adequate non-commercial data management software. Public research funding agencies need to consider these challenges in their funding policies. They also could support common spaces where North-South collaborative research groups may share critical information, such as on research insurance and opensource, GCP-compliant software. WHO should update its GCP guidelines, which date back to 1995, to incorporate the perspectives and needs of non-commercial clinical research.

"You can save time if…"—A qualitative study on internal factors slowing down clinical trials in Sub-Saharan Africa

“…These publications are not directly reporting on factors slowing down clinical trials, but list general challenges. A particular challenge reportedly associated with clinical trial delays is the lengthy regulatory and ethical review process [2, 14–16]. The complexity of the latter is compounded by multiple ethical reviews and communication gaps between the committees and authorities [14, 17].…”

Clinical Research in Neglected Tropical Diseases: The Challenge of Implementing Good Clinical (Laboratory) Practices

“…The challenges of implementing GC(L)P in LMICs have been described by different groups in sub-Saharan Africa, for instance in the fields of a multi-country malaria trial [8] and of vaccine research, respectively [9]. More recently, they have been discussed in the frame of the Ebola outbreak in West Africa [10].…”

Global Regulatory Developments for Clinical Stem Cell Research: Diversification and Challenges to Collaborations

“…Differences between regulatory rules in these countries must be singled out at an early stage, so as to design clinical trial protocols that conform to multi-jurisdictional frameworks. This is a time consuming process that is complicated further by language barriers, cultural differences and differences in the ways in which regulatory requirements are enforced [55]. It is complicated further because different types of cells and stem cells are often regulated by different government agencies and different regulatory requirements and rules [56].…”