In this first step towards developing a clinical research study, the researcher must determine the research question or hypothesis to be tested. This may be as a result of reviewing current research studies or be driven by the development needs of a medicinal product, new diagnostic, device or procedure. It may also be that you have a hypothesis to test such as ‘could a specific new hygiene practice reduce maternal deaths in rural health care settings in East Africa’ or ‘could sending informative text messages to nurses help them explain to HIV patients how to take their treatments’.

A good clinical study comes down to setting a single and clear question, which is your primary objective, and then determining what you are going to measure in order to answer that question, your primary endpoint. If you keep this in mind in everything you do then you will run a good study. What is my question? Is what I am doing going to answer that question – accurately?

A useful framework to develop the question is the PICOT framework where you describe

- Problem
- Intervention
- Comparison
- Outcome
- Time

Once the research question, which may be a hypothesis, has been set, the methods to answer it and the feasibility of conducting the study can be determined. At this stage, it is useful to write a brief concept protocol.

A concept protocol is a short document which outlines:

- The context and evidence around the research question – so usually defines the problem or gap

- The research question and the hypothesis to be tested – the objective

- Sets out what needs to be measured to answer this question – the endpoints

- The proposed study population

- The study design

- The key methods by which these measurements can be made

A concept protocol is useful in gaining feedback from colleagues and experts in the field on the feasibility of conducting the research. It can also be used to introduce the study to trial sponsors, potential funders and trial sites.

After reviewing and incorporating feedback from all reviewers, the researcher can begin to develop the full protocol.

WWARN has a collection of literature reviews which provide a valuable resource for researchers as they develop their clinical study programme. These reviews are a valuable reference tool for researchers to identify gaps in data and information, consider publication trends over time, consider the different study approaches and identify relevant clinical studies which might contribute trial patient results for further pooled analyses (see WWARN study groups).

WWARN Tools: monitor and track the emergence and spread of antimalarial resistance find out more here.