To our knowledge, this is the first in-depth analysis of communication plans in clinical trials to date. The use of communication plans in global health clinical trials is lacking. Of the 48, 21% ( n = 21) protocols included communication-related language, and 10% ( n = 5) described plans to share trial results with participants. None of the 48 mined clinical trial protocols included a communication plan. Qualitative interviews ( n = 7) were used to gather knowledge and insight from clinical trial experts to inform the development of a communication plan template. The semiquantitative analysis included mining publicly available clinical trial protocols for communication-related language. We carried out a mixed-method study over a period of 6 months to understand the role of communication with study participants and other stakeholders in clinical trials. While the template was drafted in the LMIC context, the principles are universally applicable and should be considered best practices for all global health clinical trials. Our aim was (1) to understand what, if any, role communication plans play in current global health clinical research protocols and (2) to use our findings to develop a communication plan template tailored to clinical research carried out in low-and-middle-income countries (LMIC) while minimizing colonial assumptions.

Though participants have both a right, and a desire to be informed of research outcomes, studies show that they rarely receive communication about study findings. As part of this pillar of research ethics, participants and other stakeholders should be made aware of research findings after a trial has been completed. Clinical trial participants have a right to be informed throughout the entire process of human subject research.

Nvivo version 12