Increasing protocol suitability for clinical trials in sub-Saharan Africa: a mixed methods study

Area of Science:

• Clinical research methodology
• Global health initiatives
• Health systems strengthening

Background:

• Clinical trial protocols are critical documents impacting study execution and outcomes.
• Protocol suitability is often overlooked in practice and research.
• Investigating protocol suitability is essential for improving clinical trials, particularly in sub-Saharan Africa.

Purpose of the Study:

• To investigate the suitability of clinical trial protocols in sub-Saharan Africa.
• To identify measures that enhance protocol suitability for trials in this region.

Main Methods:

• Exploratory mixed methods design.
• Qualitative interviews with 36 trial staff across Ghana, Burkina Faso, and Senegal.
• Online survey among trial staff in sub-Saharan Africa to assess protocol suitability.

Main Results:

• Trial staff identified protocols as lacking clarity, implementability, and adaptation to local contexts.
• Local site staff involvement in protocol development was the most effective measure for increasing suitability.
• Contextual assessment, staff understanding, and consideration of local capacity were also important.

Conclusions:

• Protocol suitability can be improved by early discussion and review with trial staff, especially those with operational experience.
• Involving staff from high-recruitment sites in multicenter trials is recommended.
• Thorough contextual assessment (workforce, infrastructure, participant needs) is vital for suitability.