For every clinical trial, the sponsor and/or a CRO will conduct a site selection process to determine what research sites are suitable to conduct their trial. A site’s ‘suitability’ is measured by a multitude of factors including but not limited to previous experience conducting clinical trials, research experience for a specific indication, resources available at or to the site, the surrounding patient population, data collection procedures, SOPs and training of site personnel.
Historically, site qualification consists of two parts: 1) completion of a feasibility questionnaire (FQ) and 2) an on-site site qualification visit (SQV). While identifying the best sites to partner with can contribute to a study’s success, this process can take up to 30 percent of a clinical trial’s timeline. Additionally, the work involved for all involved parties is repetitive and time consuming.
According to CenterWatch Weekly, sites and sponsors have been working to improve site qualification processes through the use or development of new technologies.
To begin the selection process, sponsors or the associated CRO will send out a feasibility questionnaire (FQ) to a list of sites. FQs are usually sent as a word document to the site or a PDF document that must be printed and completed by hand. Through the questionnaire, they gauge the site’s interest in conducting the study and look at the site’s capabilities and past research experience. Some questionnaires can take up to 90 minutes to complete and due to the lack of standardization across sponsors and CROs, sites cannot reuse or recycle them.
So how can FQs be improved?
1. Complete movement to web based questionnaires
Moving away from paper based processes allows sites to efficiently complete FQs. CROs and sponsors are also able to easily compile and analyze responses.
2. Standardize questionnaires
While complete standardization of FQs is difficult to achieve, sponsors should work together to create a standardized document for basic questions. Topics such as site facilities, standard operating procedures, recruitment processes and site personnel should be included in this section of the FQ. With a standardized document, sites can recycle it between trials and update it when needed. This will leave sites with additional time to answer questions specific to the trial.
3. Use a central electronic platform for data sharing
With a central electronic hub, participating sites and sponsors can broaden their reach. Sites would be able to attract more sponsors with ease and sponsors can search for appropriate sites based on information entered by investigators. Cognizant, along with several larger pharmaceutical companies, created a platform called Shared Investigator Platform (SIP). SIP is a cloud based system that allows sponsors to search for sites and exchange information. WCG Clinical is also developing a feasibility tool that will help sponsors quickly identify sites. This tool may also help their clients make informed decisions about who they send feasibility surveys to.
While FQs are in need of an electronic upgrade, it is important that sponsors avoid adopting a cookie cutter mentality as it may result in the quick elimination of sites that may actually be very successful. In the first session of the webinar, How Sites Can Win with De-Centralized Trials: Remote Feasibility, industry experts advise that FQs should serve as a broad assessment of a site’s capabilities, focus on a site’s willingness to try new things and capture each site’s context and color. In summary, when designing FQs, sponsors and CROs should make the process easier for sites to complete, but cannot eliminate questions that provide valuable insight on a site/organization.
Site Qualification Visits
Site qualification visits (SQV) are considered another essential component of the site selection process. After review of a completed FQ, a representative from the sponsor or CRO will perform an on-site qualification visit to meet site personnel and view the facilities. Other topics of discussion can include investigator responsibilities, qualifications of team members, review of the study protocol and review of study specific procedures. Prior to the COVID pandemic, CRAs would conduct two, possibly three visits per week, a number limited by time and physical location.
Due to the COVID pandemic, sponsors were forced to adopt video conferencing platforms, changing the way SQVs are conducted. With remote visits, sponsors could theoretically perform two visits per day, drastically increasing efficiency and decreasing cost. Industry experts are hoping that COVID will continue to push the idea of remote SQVs forward.
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