Clinical research studies are becoming increasingly complex with studies that may have challenging inclusion/exclusion criteria, urgent timelines or competing studies. These are only a few factors that increase the potential for delays and which have significant implications regarding time and cost. Delays can severely impact an organization. The most effective means of mitigating the risk for delays is conducting a comprehensive clinical trial feasibility assessment.
Feasibility assessments should be reciprocal. Sites proactively seeking all information pertaining to a specific protocol are able to make educated predictions and provide valuable insight to study planners. Requesting information from the sponsor or CRO will empower a site to determine whether their capabilities align with the requirements of the study, and can make informed decisions regarding participation.
In an attempt to gather information quickly, sites are often requested to provide specific information without an adequate amount of relevant background or time to complete a questionnaire. In an attempt to bring more studies to the site, forecasts may be over-predicted. This can result in committing to targets that are difficult to meet, which may break down the relationship between the site and sponsor/CRO. Making a point to ask the right questions before making an assessment will not only produce more achievable targets, but will strengthen the relationship between the site and sponsor/CRO.
Important factors to think through when assessing feasibility are access to patients, recruitment challenges, the expectations of the sponsor and financial viability. Of course, this is not an all-inclusive list, and the topics to consider may vary depending on the study.
Sites run the risk of underselling when it comes to disclosing their access to patients. The number of patients in a database is not always the most accurate gauge of a site’s potential patient pool. Consider the investigator. Does he or she own a private practice? Could the investigator refer subjects? Evaluate the geographic area and determine places potential patients may go to acquire information.
Enrollment challenges may vary greatly. If the enrollment period runs through a holiday season, recruitment numbers could be affected. Competing trials are occasionally a concern, especially for rare indications where the patient pool is typically smaller. When forecasting enrollment numbers and timelines, it is important for the site and study planners to keep this in mind as the presence of other studies can affect the pool of potential study participants. Checking ClinicalTrials.gov for similar studies can be helpful; however, the website may not include all active trials.
In order to ascertain feasibility at the site level, it is important to be clear on the goals of the sponsor. Ask about the protocol and discover where it is in the development process. Knowledge of the study budget, EDC or CRF requirements and timelines are key information that can be crucial to determining feasibility for a study.
Another important component of the sponsor/CRO/site relationship is a good understanding of the study budget and payment terms. Will the site be expected to carry the cost burden throughout the study? For example, if a patient is receiving a $175 stipend for a high enrolling study and a site enrolls 100 patients, $17,500 is needed to reimburse subjects. In many cases this is not taken into consideration and the site is left to deal with cash flow issues. This should be discussed in detail during the feasibility process. Also determine if site payments will be processed in a timely manner and how much cash flow may be required of the site to maintain the requirements of the study.
Feasibility is a reciprocal activity in an ideal world. Perhaps it would not be unreasonable to think that the site should request a “reverse feasibility” process once the sponsor/CRO document is issued. In order to determine the site’s willingness to answer and engage in study-specific research, an assessment is required to complete the feasibility questionnaire to begin with. See Table 1 for a representation of questions the site might pose prior to feasibility completion.
It’s a new day regarding the flow of communication among the clinical trial stakeholders. As our voice strengthens, feasibility is but one area whereby it is important that sites become more involved and engaged.
Dr. Christophe Berthoux has been the chief executive officer at Synexus since September 2010. Synexus is the world’s leading site management organization (SMO), dedicated to the recruitment and management of clinical trials across the globe for over 24 years. Email comments and questions to firstname.lastname@example.org.
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