Clinical Trials Operations Research

Efficiency and Quality in Conducting Clinical Trials in Low-Resource Settings

Clinical trials in sub-Saharan Africa are critically important to improving the health of local populations. The conduct of clinical trials in low-resource settings may pose significant ethical, regulatory and logistical challenges. The ICH-E6 Good Clinical Practice (GCP) guideline provides an international ethical and scientific standard for clinical research.

However, the pharmaceutical industry tends to prioritize faster trials and regulatory compliance over cost savings, risk-adaptation and reduction of complexity of trials. This may be in sharp contrast with the health system reality in low-ressource settings. Though, the ICH-GCP guideline leaves leeway for implementation according to the risk of the trial. This risk-based notion will even be more prominent in the E6 Integrated Addendum to ICH-GCP. Factors to consider are the regulatory and ethical environment, vulnerable populations, existing infrastructure and educational levels as well as involvement of local researchers in the trial preparation.

Although many thoughts have been informally expressed, research in clinical trials operations in resource limited settings has been marginal so far. In a series of PhD and MSc theses we investigate these operational challenges using qualitative and quantitative methods. We aim at identifying and mitigating the major deficits of the practical conduct and management of clinical trials in these setting. Improvements in this area will have a direct impact on the effectiveness of clinical research in resource-limited settings.

Lwala-Kampala, Uganda, 2014