The site selection process of a clinical trial can be daunting, especially when there are so many important factors to consider. PCRN has done some of the work for you by ranking eight of the most important factors when it comes to site selection.
1. Patient Enrollment Capabilities
A clinical trial can’t move forward without patients. There are many subfactors to consider regarding patient enrollment capabilities, such as enrollment goals, population access and profile, speed of enrollment process, visit scheduling, recruitment, communication, reporting, and more.
Population Access and Profile
In a recent survey investigating criteria for site selection, 75% of participants agreed that their company would be interested in cooperating with an inexperienced site if the site had access to a large patient population.
Trial sites that are best at having first patients ready for enrollment right after site initiation visit are preferred over factors such as good data quality, documentation, reporting and communication or updated equipment (1). In the same study, 88% of site facility participants preferred to reach enrollment goals at trial sites in their region 10% quicker than at 20% lower cost.
Protocols with at least one substantial amendment increased the average duration of a study by approximately three months. What’s more, sites with excessive regulatory compliance burden and a challenging operating environment have led to a staff investigator turnover rate of 40% each year choosing not to return to conduct further trials. Site contracting, budget negotiations, and submissions can cause inefficiencies, leading to unexpected costs and delays (2). Find a network with multiple sites and one contract to save time and money down the line.
3. Phase of Trial
The phase of your trial can help you prioritize site qualities. For example, if you are conducting an early phase trial, then data quality and investigator experience are extremely important (1). However, after it has been established that the drug is safe for humans, then you can start to prioritize other factors like budget or commitment level.\
Commitment counts: 52% of those surveyed worked for companies that selected an inexperienced site over an experienced one due to higher level of interest and commitment (1). Experience works best when paired with commitment and dedication.
While experience may not necessarily be as important to your trial compared to commitment level or patient enrollment goals, it can still make a huge difference during a clinical trial. Experienced staff members who understand protocols thoroughly can help reduce the average time it takes to conduct a study.
How important equipment is depends largely on the design and therapeutic area of your study.
However, updated technology and software, such as online document exchange portals and shared investigator databases, help streamline any clinical trial process, saving you time and money (2). In addition, making sure your site has the specialized equipment needed for a particular therapeutic area is crucial. However, if you’re working on a primary healthcare trial or don’t need access to specialized equipment, prioritize other factors.
7. Geographic Location
Geography once played a much larger role in site selection. However, COVID-19 forced a transformation in the way clinical trials are run. Staff are no longer required to be in the lab every day. Patients can get their trial medications delivered to their door unlike ever before. COVID-19 showed the industry that geographic location is not the burden it once was (4).
Once your patient population has been determined, you can better target the right geographic location for your trial based on where that patient demographic lives. If you’re working with a CRO, use their regional experience to help you determine an appropriate site location (3).
Cost is one of the last factors you should consider. Even if you are trying to conduct your trials on a tight budget, you should prioritize all the above first. When you focus on what is most important when striving for your goal, you are decreasing your likelihood of delay and higher, unplanned costs down the road (3).
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