Clinical Trial Site Feasibility

Definition of site feasibility

For clinical trials conducted at various research sites, the selection of appropriate sites for conducting the research sets the foundation for a successful trial. Site feasibility describes the process of verifying that prospective sites are capable of running that particular study, with adequate resources, facilities, knowledge, and personnel.

Factors that impact site feasibility in clinical trials

Many factors play into whether or not a site is feasible, including its geographic location, availability and training level of personnel, infrastructure and equipment, prior experience in similar studies/therapeutic areas, safety and compliance records and SOPs, and access to relevant patients. A thorough evaluation of these factors must be conducted before a clinical trial agreement (CTA) is signed with the site in order to ensure that trial operations are left in capable hands.

The importance of site selection in clinical trials

Selecting high-performing sites is part of effective clinical trial design, and carries significant implications for timely completion and success of clinical trials. Site feasibility studies are an essential step in the site selection process, and help sponsors determine the ability of a potential site for hosting a given clinical trial by evaluating the suitability of the site’s infrastructure, staff, and facilities against criteria based on the specific needs and objectives of the trial.

It’s particularly important to consider the desired study population, and whether the site has access to eligible patients. For studies involving in-person study visits, the proximity of patients to the study site should be taken into account in order to ensure recruitment targets can be met.

What is a clinical trial site feasibility study?

A comprehensive investigation into all aspects related to a prospective site’s potential to fulfill the research needs of the trial is known as a 'site feasibility study'. A site feasibility study will usually cover a wide variety of aspects about the site, and is designed to provide the sponsor with a clear idea of whether the site may be capable of conducting the clinical trial according to protocol.

It also allows sponsors to foresee and predict potential challenges that may arise during the course of the study. For instance, it could help sponsors anticipate issues with recruitment or retention of patients in a specific geographical area, or identify sites which may need additional training or support on a certain software tool. Ultimately, site feasibility studies help sponsors make informed decisions about where to conduct their clinical trials for optimal success.

Factors to consider when conducting a site feasibility study

Multiple factors are taken into account when determining site feasibility, and can include:

• Geographic location
• Qualifications & experience level of investigators
• Availability and capabilities of staff (including up-to-date training records)
• Compliance with legal regulations pertaining to conducting clinical trials in the local jurisdiction/country
• Physical resources like medical supplies and equipment, clean and well-maintained facilities
• Specialized skills or medical knowledge, as required by individual studies
• Assessment of the available participant demographic against the trial’s basic eligibility criteria, such as age, ethnicity, and principal diagnosis
• Local regulations, which may influence cost and timelines
• Potential cultural subtleties and the familiarity of the site with these
• Evaluation of overall safety standards at each prospective location

Steps involved in conducting a site feasibility study

The steps involved in carrying out a site feasibility study can vary depending on the nature of the particular trial being conducted as well as other factors related to the location and the prospective site. Generally speaking, key steps include:

1. Identifying a wide variety of potential sites
2. Collecting detailed information about each site via site feasibility questionnaires (SFQ; see next section) from each investigator or facility being assessed
3. Compiling results to narrow down the list to a smaller subset of high-potential sites
4. Communicating with those sites for further clarifications, and likely conducting a site visit
5. Agreeing on terms through a clinical trial agreement.

We have written a detailed article on the steps sponsors can take to optimize site selection.

Site feasibility questionnaire (SFQ): An invaluable yet limited tool for site selection

A specific tool often used to facilitate site selection is the site feasibility questionnaire (SFQ). An SFQ is a survey designed by the sponsor which has the aim of collecting information about potential research sites in a consistent and organized manner. This makes it easier to quickly identify sites with the highest potential in consideration of the specific needs of the trial at hand.

The SFQ typically consists of multiple-choice (or otherwise constrained) questions covering topics such as investigator qualifications, staff training and capabilities, performance history, facility and equipment availability, previous experience working on similar clinical trials, etc. It can be customized by the sponsor to reflect the protocol and requirements of the particular clinical trial being conducted. The responses obtained via SFQs can provide critical - although somewhat superficial - insights into how suitable a certain site may be for hosting the clinical study. As we will discuss next, it’s usually necessary to visit the site or at least communicate directly with the principal investigator in order to go beyond the information provided in the SFQ - which is self-reported - in order to verify that the reality of the site’s operational capacity matches that stated on paper.

Visit the site in-person to verify feasibility

Determining the feasibility of a site you haven’t worked with before is not as simple as sending out the SFQ. Since responses to SFQs are self-reported, there is a tendency for sites to exaggerate - particularly when it comes to recruitment capabilities. Other things that can’t be accurately or completely captured through surveys include the cleanliness of facilities and how presentable they are to patients, verification of staff training records, and availability of medical supplies, to name a few. For this reason, conducting an in-person site visit is usually an essential prerequisite step before signing a CTA with any site. In this visit, the sponsor (or a representative such as the clinical research coordinator or monitor) has the opportunity to verify information reported in the SFQ first-hand; discuss and clarify any doubts with the site’s investigator and staff; inspect facilities, training records, SOPs, and supplies; and establish a personal connection, which may improve the communication between the sponsor and the site. It is important that the sponsor feel confident in the site’s ability to conduct the trial smoothly, and the CTA should clearly lay out all aspects of the working relationship, with doubts and specifics previously agreed upon through transparent and effective dialogue.

Other potential difficulties in determining clinical trial site feasibility

Another potential difficulty arises in international studies requiring sites in different countries, as applicable regulations as well as cultural nuances vary widely between regions and can have significant impacts on trial operations. Language barriers represent another issue to overcome, as it is absolutely essential that both parties clearly understand the details of the arrangement as laid out in the CTA. In such cases, best practice may involve contracting a local representative who is well-versed in clinical research in the destination country, but who is also familiar with the internal goals and protocols of the sponsor organization.

Conclusion

Effective site selection involves thorough feasibility analyses of potential sites as well as open dialogue and two-way communication between the site and the sponsor organization. By closely examining all relevant features and capabilities of prospective sites, sponsors can increase the chances of a successful trial and minimize risks, delays, and costs associated with shortcoming in meeting recruitment targets, miscommunications and misunderstandings, or an incapability to conduct the trial smoothly and comply with regulations.