Enrolling enough patients is crucial to the success of any clinical trial. Even then, new therapies are crucial in improving the health of cancer patients. Despite this, carrying out clinical trials comes with some challenges, especially when picking a clinical site. But this can be overcome by choosing a site that satisfies the clinical trial design, as this will impact the Veristat study schedules, data quality, and final findings. Below are steps you can apply in selecting a location for your clinical trial.
Identify the site’s requirements and criteria for selection
The first step in choosing a clinical study is to specify the size criteria that must be met explicitly. That should also cover research duration, staffing and facilities, participant profile and enrollment goals, and timetables. As such, defining the requirements during clinical trial planning will make the process go more smoothly and aid in selecting the best location. It’s also crucial to distinguish between must-haves and flexible requirements while developing the criterion. Since there are no one-size-fits-all requirements, defining the trial requirements can also provide a viable basis for analyzing and categorizing different available sites according to the kind of trial you’re carrying out.
Locate potential sites and collect preliminary data
Once the requirements have been established, the search for a suitable location can begin. Sites can be found via various paid and free tools, including a Contract Research Organizations (CRO) list of probable sites and online and offline directories. However, the best tool is one that offers filtered features such as facility, location, staffing, and size. They also provide insights on previous trials, demonstrating the site’s suitability with the targeted research. After a viable site has been identified, a request for information or participation in a clinical trial is sent to the principal investigator (PI). Before further study details are revealed, a Non-Disclosure Agreement (NDA) is established based on the PI’s interest. The study protocol can then be shared with the PI, and the site can get a survey with specific questions that address each of the pre-defined criteria. Specific questions or responses may need to be clarified, and other papers will be asked.
Assess and select sites
To ensure that everyone is on the same page, incorporate site administration staff in charge of contracts and budgeting early in the process. Setting expectations will result in a more efficient start-up and execution of research. Suppose the sponsor does not specify a cost per patient. In that case, the site should also present a projected budget that includes research setup costs, study conduct fees, closeout fees, and an overhead percentage. Site Monitors should also undertake Pre-study Visits (PSVs) or Site Selection Visits (SVS). In doing so, they’ll assess whether the investigator has the necessary personnel, time, subject population, facilities, and equipment to complete the study correctly. The study is also intended to develop a connection with the PI and site personnel and explain in length the study’s objectives, endpoints, design, methods, and expectations.
To identify and select a viable site, the study criteria must be clearly defined from the start. Afterward, Pre-study visits must be conducted in potential sites for further assessments.
