Conducting clinical trial feasibility is vital and one of the first steps in the clinical study process. It aids in determining the effective and efficient use of resources. Accepting a study that is a good fit for the site not only increases revenue, but it also helps further the overall goals of the site and its Principal Investigator (PI). Underperforming studies put an unneeded strain on the site and sponsor, and therefore should be avoided.
Here are five areas to take into consideration during the feasibility assessment process.
Site Readiness
It is necessary to determine a site’s readiness to conduct the study in advance. After reviewing the protocol and study design provided by the sponsor, the PI must be interested in the research he/she will perform, the study drug or intervention, and be qualified to take on the study. There are certain indications that require board specialization or prior study experience to be considered by the sponsor.
Study Experience
Another aspect to consider is if the site has conducted similar studies in the past. If so, what were the results of these studies? Were they particularly easy or extremely challenging to conduct? What was the overall experience for the PI and research staff? A good track record for the site increases the chances of success for the study being considered.
Identifying Challenges and Getting Investigator Input
Identifying any potential challenges in the protocol or overall study design is an important area that is explored in clinical feasibility. Speaking with other physicians and sites within a site network, like Headlands Research, allows insight that single sites may not have readily available. Sites that have a KOL, experience with similar trials and/or the target indication are ideal. Investigator feedback is one of the most important factors when deciding to take on a study. Centralized information is gleaned from previous and active trials across sites and used for evaluation.
Study Requirements and Protocol
Each study has specific criteria that should be considered. Along with having adequate personnel, a site must determine if it has the space, equipment, and time available to carry out the study.
The study’s protocol may require specific equipment including refrigerators, freezers, and certain lab instruments. Are there resources available if the site does not have this equipment on hand? Can the site utilize a vendor or nearby organization? Is there capacity for additional research procedures if necessary?
Effective time management is critical to a successful trial. What is the expected timeline for study start up and site activation? How many other clinical trials are currently being conducted or expected to start during the anticipated study timeline? Will this study complement existing studies or compete with them?
Regulatory and other study processes must be established prior to feasibility. Does the site have a system to efficiently collect and record data? Are there any potential regulatory or ethical challenges to consider? Does the site have a business continuity plan in place?
Reaching the Target Patient Population
Finally, the desired patient population must be analyzed. The site’s geographical location plays an important role. Does it have access to the necessary patient population and does its current database already contain the patient group? If not, is there a way for the site to recruit the desired population?
If the site has access to the target patient population, it must determine how it will engage and connect with them. Are there creative recruitment methods that can be utilized? What type of marketing is most effective with this patient population or therapeutic indication? Is this trial attractive to prospective patients and are there any unique characteristics or selling points? Is this study promoting research that is well known and generally trusted by the public or is it newer and may carry some uncertainty with patients? Would a patient perceive the number of study visits and procedures to be reasonable?
Not only does the target patient population need to be recruited but they must satisfy the inclusion and exclusion requirements outlined in the protocol. If applicable, enrollment goals and timelines provided by the sponsor must be reviewed. Sites should identify any enrollment issues and create action plans to address them.
One of the most important factors sponsors consider when selecting study sites is the potential to recruit diverse and underserved communities. What is the expected percentage of diverse patients in the trial? Having a diverse study team and/or bilingual staff is very beneficial when conducting clinical trials. Finally, it is important to ensure marketing for the study reaches the target audience to achieve the diversity goals.
The feasibility process examines if the site will be successful in conducting the study. Population demographics, recruitment methods, investigator and site experience, enrollment and screening estimates and expectations, and the capabilities of the research site should all be considered. During the site evaluation, it is not only important to explain how the site will be successful with study recruitment and enrollment but also how the site will provide superior patient care and ensure quality data. Sites should communicate effectively with the sponsor, CRO, and all other monitoring personnel during the entire study process.