Once a question has been set the next step is to consider the methods to answer it. At this stage, it is useful to write a brief concept protocol. This document can be helpful in introducing the idea to all the groups that are likely to be approached for approvals, such as:
- Trial site management team
- Hospital/district health management team
- Potential funders
- Trial sponsors
- Drug/intervention manufacturer
- Experts, colleagues, other researchers in this field
A short one or two page concept proposal can be discussed with all potentially interested parties at an early stage. When working with external sponsors or developing multi-centre trials it is common practice to hold protocol development meetings to encourage contribution to setting the question and designing the protocol. Group input is helpful as it ensures that the proposal fits strategically within the sites where it is being planned and allows early input on the design and methods to make sure that the best and most robust approach is taken. It also ensures that everyone who needs to be involved is made aware and can contribute at an early stage. Again, a concept protocol provides a helpful document with which to begin discussions.
For locally led or single-site trials it is still good practice to hold protocol development meetings. These can take place within the research site and involve relevant staff or other colleagues with appropriate expertise to help develop the question into an appropriately designed protocol.
Wider expertise that is commonly required for protocol writing might comprise:
- Clinical Laboratories
- Statistics and IT
- Human Resources
- Finance and Administration
- Ministry of Health or other regulatory body
- Community representatives