Smart Feasibility Process® (SFP) – a term coined here at PharmaSich – comprises multifactor site selection, identification of potentially problematic contracting details and/or local ethics committees’ requirements, assessment of available patient-recruitment strategies. This service is available as a stand-alone solution or as a part of our full-service engagement.
When it comes to site selection, the importance of this step is hard to overestimate. Patients availability is the key factor for assessment, as well as utilized methods for patient identification. Patients’ pre-screening (if applicable) and maintenance of a local patients’ database are welcome since the investigators start paying attention to the study long before it fully commences. Potential sites’ experience of participation in clinical trials in general and in trials with similar design or products is definitely of interest. Identification of ongoing or planned competing trials at a site is quite important since such overlap might influence the expected enrollment accomplishment on several levels.
During the process of potential sites assessment, we identify several kinds of sites based on their potential enrollment and research experience: skilled high-enrollers (though limited in number) with good track record; sites with a moderate enrollment potential (more numerous); sites with limited or no clinical trial experience but of high potential and willing to grasp the opportunity to enter the fabulous world of clinical trials. Based on sponsor’s preferences, site selection can be narrow and targeted or wider and more inclusive.
Identification and assessment of available site facilities and equipment is important and is a key factor for a quick start-up.
Most often than not, sites’ patient identification strategies determinate their future enrollment results. During feasibility process our CRAs may discuss site’s current approaches and act as solicitors giving advice and helping sites with deployment of strategies boosting referrals or patient identification.
Eliminating administrative hurdles has always been an issue in Eastern European countries and has to be paid close attention to. Things as simple as site’s investigational team portfolio with resumes and valid GCP certificates must be available. Sites need to have valid contracts with their service providers, and their vendors need to be certified, if such third-parties are planned to be involved in an upcoming trial. Primary investigators have to be on good terms with their hospital or institution administration so that the latter should be willing to cooperate and give the green light to investigational projects. Contract templates must be verified by hospital’s lawyers to prevent unwanted glitches.
When it comes to ethics committees, their specific requirements as well as processing timeframes and expected work schedules have to be identified and taken into consideration. It may require some additional communication between the investigator and the respective local ethics committee to ensure that their procedures are in accordance with GCP requirements and the wording of their produced documents is clear and acceptable.
All these preparations can be done in advance to ensure smooth and fast start when time comes. Proactive identification of possible issues and preventive actions for their mitigation are part of Smart Feasibility Process® here at PharmaSich.