Feasibility and Site identification are fundamental critical aspects of planning and executing successful Clinical Trials.
Feasibility and Site identification involves identifying potential Sites that meet the study’s eligibility criteria, based on factors such as patient population, Site capabilities, access to the required clinical infrastructure and personnel, regulatory requirements, logistical considerations, and appropriate locations where the Clinical Trial can be conducted.
Feasibility can be performed at 3 levels: Clinical Program Level (assesses the overall strategy of the set of Clinical Trials of a particular study drug/device), Clinical Study Level (assesses the strategy in a given Clinical Trial) and Site/Investigator Level.
This article aims to briefly describe the processes of Feasibility and Site identification at a Site/Investigator Level.
To identify suitable Sites, Clinical Trial Sponsors and/or assigned Clinical Research Organizations (CROs) often use various tools and resources, including databases of potential Sites, previous experience with similar Clinical Trials, and recommendations from Investigators or Key Opinion Leaders (KOLs) in the relevant therapeutic area.
Once potential Sites have been identified, Sponsors/CROs utilize their agreed and documented procedures of contacting them and making necessary assessments. Usually, the starting point of further communication is the execution of Confidentiality (Non-Disclosure Agreement) between Sponsors/CROs and potential Sites, so that confidential Trial-related information & documents can be shared.
Feasibility assessments are usually conducted in a form of distribution of corresponding feasibility questionnaire/survey with further Site interviewing and discussion of provided Site’s feedback.
Feasibility assessments aim to identify if Sites have the necessary capabilities and resources to conduct the Clinical Trial successfully according to the proposed design, timeline, and budget. Feasibility process also helps to determine the potential risks, challenges, and opportunities associated with Clinical Trial conduct and among other considers the Site infrastructure, patient recruitment potential, regulatory and ethical aspects, logistical setup etc. This information can be used to refine the study design and identify potential strategies for addressing any barriers that may arise during the Clinical Trial.
Below is the non-exhaustive list of aspects which are being assessed during Feasibility and Site Identification process:
1) Clinical aspects: overall interest of Investigator in the research field, study population and actual number of patients seen by the Investigator per given time period (e.g., month/quarter/year); standard of care and readiness to accept background and comparative therapy, as well as level of training/knowledge for specific treatment tools and technology
2) Site “demographics”: geographic location of the Site since it may influence patient’s access and availability of Sponsor/CRO to control Clinical Trial conduct. Evaluation of Site Staff’s experience, such as Primary Investigator, Sub-Investigator(s), Pharmacist(s), Nurse(s), Study Coordinator(s) and their proficiency in terms of Protocol related knowledge; assessing Site staff availability to conduct the Clinical Trial
3) Recruitment and retention: evaluation of recruitment potential of Site (usually per month or per year) throughout the duration Clinical Trial. Identification of any conflicting studies that may influence patient recruitment. By gathering this information, a “less Sites – more patients” approach can be introduced for cost saving and quicker enrollment purposes by choosing the most prospective Sites
4) Regulatory & Ethical aspects: gathering of information on local requirements for obtaining Regulatory Authority’s and Ethics Committee’s Clinical Trial approvals, requirements for Trial documentation and translations (if any)
5) Site infrastructure: adequate facilities that meet Protocol requirements and Good Clinical Practice standards. Clinical Trials have specific requirements related to study drug/device storage, processing of biological samples (e.g., refrigerated centrifuge etc.), necessary equipment to conduct trial-related procedures etc. It is important to assess Site’s capabilities related to such requirements, whether everything required is available at the Site or needs to be procured, whether there are Site staff members who have the relevant expertise to conduct these activities and use such equipment/tools. Most of Clinical Trials utilize electronic Case Report Forms (e-CRFs) and other electronic Trial systems and it is important to assess whether Sites have capabilities to use electronic data capture and their familiarity with such tools. It will also be assessed if Site has capabilities to provide enough working space for Clinical Trial Monitoring procedures as well as for hosting Regulatory Inspection(s) and Site Audit(s)
6) Quality: one more aspect which also needs to be evaluated is whether Sites have undergone Sponsor/ independent Site Audit(s) in the past. It may be advisable to check whether the Site had undergone any FDA/EMEA audits and if so, were any concerns/findings raised.
Based on the findings of the feasibility assessments, the Clinical Trial Project Team can then make informed decisions about which Sites should proceed to Pre-Study Site Selection Visits (can be performed on-site or remotely) and eventually be approved for participation in the Clinical Trial (mandatory subject to approval of applicable Regulatory Authorities and Ethics Committees).
Carpathian Research Group capabilities
CRG as a CRO considers Clinical Trial Feasibility & Site Identification service among our key strengths as we effectively utilize our strong in-house medical expertise and connections with Key Opinion Leader(s) in numerous therapeutic fields.
Information on all other Clinical Trial services that we provide could be found at www.crg.global