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The industry evaluates a study site in terms of standard metrics in order to understand whether a site would be suitable to conduct the trial in question, by means of a feasibility study. This so-called feasibility study could be conducted by means of a standard questionnaire and/or by making a site visit. Based on the outcome of a feasibility study, a site may or may not be offered a role to participate in a trial. It is highly recommended that the site obtains a copy of the full protocol before completing a feasibility study. This will allow the site to better understand whether the trial may be of interest or even feasible for the site. After all, it is a large commitment to embark on a trial and a participating site must know all the details of the protocol before deciding to participate.
A site feasibility study usually includes questions within six different domains, namely: (1) site clinical aspects, (2) site demographics and experience, (3) quality assurance, (4) subject recruitment and retention, (5) site infrastructure, and (6) research ethics. In the following text we will briefly describe with examples each of the six site feasibility study domains.
Site clinical aspects: Evaluation of the site's standard care and patient population, and the investigator’s acceptance of study therapies and his/her familiarity of any trial-induced investigation.
Site demographics and experience: Evaluation of site's type of clinical practice, experience in clinical trials, and availability of support staff, i.e. study coordinators, pharmacists and nurses.
Quality assurance: Evaluation of the site's quality assurance program, such as written standard operating procedures, staff induction and continuing educational activities, previous sponsor or independent site audits.
Subject recruitment and retention: Evaluation of recruitment potential, presence of competitive studies, and prior experience in conducting similar studies. The industry sees this evaluation as the most important part of the feasibility study. However, the evaluation is difficult to conduct since all information is collected from the investigator who may not disclose the correct information, for instance, overestimating the number of potential trial subjects and over emphasizing the past experiences in conducting similar studies.
Research ethics: Evaluation of the operation of the local ethics committee, such as ethics committee guidelines, application requirements and overall process, including the timeline of ethics clearance.
Site infrastructure: Evaluation of administrative support (budget and contract), drug and biological sample storage, processing of biological samples, and the presence of expertise to conduct such activities. Evaluation of whether the site has capabilities to use electronic data capture and the familiarity with such tools.
Owing to the complexities of the clinical trial process, various organizations and the industry are currently discussing ways to implement a site accreditation program so that industry-sponsored trials would only be conducted at accredited study sites.
There are, however, two problems with this proposal. First, the industry needs over 60,000 new sites for their clinical development programs annually and half of the sites are novice sites. If only accredited sites are selected by the industry, there would be too few sites available. Second, many sites are not interested in joining an accreditation program, since there are at present no incentives from being accredited.