It is ethical to conduct clinical research that answers questions that are relevant to the local population where the research is being considered. Researchers need to consider carefully the questions they set and their appropriateness to the local community and the public health gaps in the region. This applies as equally to local, independent studies as it does to externally sponsored studies. When formulating a research question the following should be considered:
- Is the question relevant to local health issues and/or public health gaps in the region?
- Will the data be of importance to the local population?
- Will it be feasible to translate the research findings into a change in practice or treatment? Note: it is important to consider elements such as cost, drug storage conditions and trial complexity.
In low to middle income countries clinical trials typically focus on children, infectious diseases and are most often not commercial. Researchers in these regions face some specific challenges when planning clinical research:
- Working with vulnerable populations and communities
- Operating research in remote and resource limited settings
- Logistical challenges such a poor roads, power supply and infrastructures
- Lack of trained personnel across all areas
Once a researcher is satisfied that the question they are considering would be of merit to the community in which they are based they can then explore whether or not it will be possible to answer that question in terms of practicalities and ethical issues. Some questions to consider are:
- Is there a high enough incidence of disease to recruit enough patients in a meaningful time frame?
- Can the question be answered without taking too many samples or performing overly invasive procedures?
- Is the intervention safe for use in the target population and is there enough data to support this?
- Will the research be acceptable to the host community and what are the best approaches for community engagement?
Once a researcher is confident that they have formulated a good question which could be answered through a well designed trial and, once answered, could improve health outcomes in a population then it is possible to begin the process of developing a protocol.