If the clinical study is still in the planning phase, amendments to the trial protocol can usually be avoided, because the Clinical Trial Liaisons (CTLs) can consider the challenges for patient recruitment and their potential solutions identified by analysing the trial protocol already when selecting the trial sites.
Within the scope of the feasibility analysis a sufficient number and, above all, the right questions have to be asked. It is not sufficient to ask the investigators to estimate how many patients with the study indication they see and how many of them they presumably can recruit for the study, and if they possess the required infrastructure and experience and sufficient personnel resources for the study.
One should start with the feasibility analysis before the trial protocol is final. Because it can be crucial for the success of a study to consider concerns and suggestions of the investigators in the trial protocol.
Proceeding from the results of the feasibility analysis the CTLs construct requirements specifications for suitable trial sites and start the selection process. From our own and external databases the CTLs select trial sites that are potentially suitable to work on the study and narrow the selection step-by-step. Needless to say suggestions from you as the sponsor are also considered. The suitability of the trial sites is evaluated by scoring to which extent they match the respective requirement specification and which potential for patient recruitment they have.
The result is a ranking list which is reconciled with you as the sponsor and then is then used for the preliminary selection of the trial sites.
The results of this feasibility analysis are
- a strategy for patient recruitment,
- a dossier with the trial sites suitable for the study,
- an action plan to meet the challenges of patient recruitment and
- an action plan to make the clinical trials work efficiently.
After the preliminary selection all trial sites are visited. At these visits the clinical study, it’s requirements and the strategy for patient recruitment will be discussed with the investigators. The study processes and the related time exposure are aligned with the investigators and their study teams. And the investigators should have a comprehensible strategy for patient recruitment. Only then a realistic instead of just optimistic assertion can be made, which trial sites can successfully conduct the study and which potential for patient recruitment they really have. Afterwards the final selection of suitable trial sites is done.
For clinical studies for which we have conducted the feasibility analysis and selected the trial sites, we give a statement on the probability to reach the goal of patient recruitment with the strategies developed and the action plans derived from them. If our suggestions are considered the probability generally reaches 85 percent.