Study Site Issues

There are several issues that a study site must address such as:

  • Identification of trials
  • Clinical Trial Agreement
  • Clinical Trial Budget
  • Subject Recruitment
  • Site Marketing

Subject Recruitment: It has been reported that around 80% of clinical investigators fail to reach the anticipated recruitment rate and 30% do not recruit a single subject in industry-sponsored clinical trials. Those figures have not improved over the past two decades. Patient recruitment is the single most important issue that continuously fails in clinical trials.

Recommend documents and readings for study staff:

Declaration of Helsinki (2013) (Click)  

The ICH GCP (E6) Guideline (Click)

Basics of Clinical Trials (English) (Click)

Basics of Clinical Trials (Chinese) (Click)

Basics of Clinical Trials (Portuguese) (Click)

Basics of Clinical Trials (Spanish) (Click)

Study Site SOPs (Click)

Study sites that have well-written, comprehensive and practical clinical research SOPs have a distinct advantage over those that do not. Well-written SOPs are the most efficient way to train new staff and to ensure that they continue to work autonomously. You can download a full set (n=55) of site SOPs developed in collaboration with an international group of clinical trial professionals from this page.

Site Evaluation

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. 

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.