Choosing the Right Study Site
Updated: Dec 28, 2021
When choosing the best sites for a study, from the location of the sites to the country, there are many different factors that need to be considered affecting multiple functional areas.
Here are just a few key pieces to evaluate:
One of the first considerations when choosing a site is which countries and parts of those countries you should look at for your study. It is important to understand the different approving authorities, as well as the approval pathways and timelines, associated with the type of investigational product (e.g., drug, device, biologic, combination therapy). Every country is different, and some countries have vastly different approval timelines with multiple regulatory bodies and/or review committees reviewing the study protocol or investigational plan. It is also important to consider timelines for start-up, such as how long the budget negotiation process may take given the nuances of a site, whether their site can work on start-up processes in parallel or if they must be sequential, how is quality demonstrated within their processes, the global logistics of import and export for shipping investigational product or biological specimens, as these may impact timelines. In tandem, it is also important to look at the incidence rates of the disease space that the investigational product is targeting within the countries being considered and choose a specific location where incidence rates are highest for your particular disease state. A carefully considered location will help ensure rapid enrollment rates.
Type of Site
After the specific countries and regions, the types of sites can be pivotal in the success of a study, and there can be many differences between types. For instance, an academic hospital and a private practice may present different timelines for approvals, types of IRB/EC to be used, number of patients seen at the site, types of facilities (e.g., laboratories, pharmacies) that can be utilized for the study, diversity in expertise, the percent of time/resources dedicated to research, and much more. A thorough site feasibility study will help determine what types of sites, or a combination of site types works best for your situation.
Performing a Site Feasibility Study
We recommend incorporating a site feasibility evaluation as one of the most integral steps in the site-selection process. First, screen the site for interest in taking on new research studies. Once that is established, determine whether they specialize in the targeted therapeutic area and if they have the bandwidth to take on additional research studies. After the initial screening, send a feasibility questionnaire to the site(s) to further determine suitability. The feasibility questionnaire typically seeks information about staff experience/availability and enrollment challenges within the targeted therapeutic area. The questionnaire also looks at information about the facility (e.g., type and approval timelines of IRB/EC [as applicable]; pharmacy, laboratory, and medical records [i.e., paper or electronic]) and whether the site’s infrastructure can manage the type of study potentially being run. After the feasibility questionnaire is completed and screened by the applicable study team, the investigators have completed an acceptability check, and the site/investigators are deemed acceptable to move forward, a site visit is conducted (sometimes virtually). During this site visit, facilities are examined to ensure that the study can be conducted appropriately. This is a key step in site selection that requires thorough documentation.
An overarching key to successful site selection is organization and tracking of all applicable information from the site to the country level. Checklists can be helpful to ensure consistent feasibility checks across all sites that are considered. As information is collected, it is important to utilize tracking tools that align with the applicable feasibility checklists so that all information can be easily compiled in the Trial Master File when it is time to decide which sites are extended participation invitations.
These are just some of the key pieces that are involved when choosing a site. We’d love to hear from you. If you have any questions or are interested in learning more about the unique approaches that Global’s Clinical Operations Department utilizes in selecting the right sites for your study, please contact us at www.globalrwc.com.