You may have a good idea for a clinical trial but are concerned that with an already busy clinical workload plus other commitments, you don’t have time to lead a clinical trial.  To help you make an informed decision, we have outlined below what is typically involved.

If your vignette is approved, you are usually expected to lead the study, you would work closely with a Trial Development Group (TDG) over the next 6-12 months to develop a grant proposal for submission to a funding body.  The co-ordinating centre can help identify statisticians, health economists etc. to form the TDG but it is best to have a supportive team behind you at this stage. Typically, the development work involves several meetings (some via teleconference) plus correspondence by email and telephone.  The UK DCTN trial development manager will arrange the meetings, draft the grant application and do the trial costings, but your clinical expertise is vital and you will need to contribute to each of these tasks.  If pilot work or surveys are required, the Network staff can co-ordinate these activities along with input from you/ your team.

If the funding bid is successful, the co-ordinating centre will help with the set up of the study (preparing protocols, gaining ethics and regulatory approvals etc.)  As the Clinical Lead, you would contribute to the development of the protocol and study procedures, again usually through several meetings (some via teleconference) plus correspondence in between meetings with the trial manager and other members of your study team.

Once the study is up and running, you would need to provide clinical input throughout the lifetime of the study and attend Trial Oversight Committee meetings. As Chief Investigator, you can delegate the day-to-day management of the study to the trial manager (and the Network co-ordinating centre) but you would retain overall responsibility for the study. You would be central to the final write up of the study and any resulting publications.  Please see our publication policy here.

It generally takes 2-3 years from submitting a vignette to obtaining funding.

Success to date:

The UK DCTN has raised over £2.5 million in external funding. The clinical leads for some of these studies are: BLISTER- Prof. Fenella Worjanowska (Oxford), STOP-GAP- Prof Tony Ormerod (Aberdeen), LIMIT-1- Dr Jerry Marsden (Birmingham).

And finally, a comment from the late Professor Neil Cox, (PATCH Trial Clinical Lead):

“This is a research avenue that simply isn’t available through any other body. It enables research to be performed using either drugs that would not attract pharmaceutical backing, or larger groups of patients than individual centres would be able to recruit. The Network team put a lot of effort into making the process of developing research and getting funding and approval as simple as possible, and give great support to the investigators. It is also a good way to hone research ideas with one’s peers, to keep in touch with like-minded colleagues, and for trainees it is a good way to become involved in research that operates at a national level and that answers questions that we, as dermatologists, feel are important.”