The Global Lack of Surgical Trials and Strategies to Overcome Barriers: A Systematic Review and Narrative Meta-Synthesis

Background: Clinical trials are the accepted gold standard method to generate clinical effectiveness data. In global surgery, there is a significant lack of surgical trials in Low and Middle-Income Countries (LMICs) due to unique barriers in trial delivery. Understanding these barriers and exploring facilitators will increase the quantity and quality of LMIC surgical trials.

Materials and Methods: To determine the number of registered surgical trials globally, the World Health Organisation (WHO) International Clinical Trials Registry Platform (ICTRP) was searched by country and by all trials registered. To identify barriers and facilitators to surgical trial delivery in LMICs, a systematic search of MEDLINE (via OvidSP) and EMBASE (via OvidSP) was undertaken. A narrative meta-synthesis was conducted using inductively generated themes via thematic analysis.

Results: Only 3.4% of all registered clinical trials involved a surgical intervention. Globally, only 32% of all registered trials recruit patients from an LMIC. There were four main barrier themes: i) Lack of human resource capacity; ii) Lack of equipment, technology and resources; iii) Culture and contexts; iv) Methodology, design and implementation. There were three main facilitating strategies to overcome the barrier themes: i) Collaboration; ii) Flexible and efficient trial designs; iii) Funding and research culture.

Conclusions: The results of this study are widely relevant and provide facilitating strategies to address challenges in undertaking LMIC surgical trials. Given the significant barriers, it is important to explore flexible trial designs, with in-built trial training and qualitative methodologies.