Planning a clinical trial
The idea for a clinical trial often comes from work that has taken place in a laboratory or experiences that doctors and nurses have of working with patients.
Before it can happen the idea has to be developed into a detail plan, sometimes called a study protocol. This usually includes:
- The aim of the trial
- The numbers of people needed
- Who can take part in the trial – sometimes called the eligibility criteria
- Details of any treatments or procedures, and who will receive them
- What tests need to be done before, during and after the trial
- Details of the information to be collected
- How long the trial will continue
- How the results will be analysed
The protocol will normally be reviewed by other teams of researchers or by an independent body. They will check to make sure that the study will work, and will, where appropriate, point out any problems that might so far have been overlooked. Patients are sometimes involved in this process too.
Getting the go ahead for a clinical trial
A clinical trial can only go ahead if funding is secured for it and if it has received the approval of an ethics committee.
Funding can come from a number of sources:
- An independent funding scheme such as the Medical Research Council
- A large charity such as Cancer Research UK or the British Heart Foundation
- A medical or food company that may have a vested interest in a particular area of research
The process of applying for funding can take some time. Before a grant is made, the funding body will need to satisfy themselves that it is a good piece of research and the best use of the available funds. The researchers will also be obligated to keep the funding body updated on the progress of their research and any results.