Feasibility assessment is one of the first steps when planning a clinical trial. The process includes an assessment of the potential for performing a clinical trial in a given country or at a particular trial site. Trial feasibility assessment is multiplanar and must include the following:
– Selection of a country where the trial is to be conducted, considering the infrastructure and equipment of trial sites, as well as epidemiology in a given place and available expert base.
– Analysis of local legal requirements and ethical conditions.
Why conduct a trial feasibility assessment?
Verifying trial feasibility allows for a realistic assessment of whether it is justified to conduct a clinical trial under the given circumstances and in the particular target group. This allows to select the trial site that is best suited to your needs, which in turn has a significant impact on the duration and cost of the clinical trial.
Which factors impact trial feasibility assessment?
- Epidemiological situation
- Availability of the relevant patient population
- Specifics of the trial site, i.e. research procedures, infrastructure
- Legal and ethical considerations at the trial location