Site selection is a foundational element in the success of a trial, akin to laying the groundwork for a stable and enduring structure. Understanding the nuances of site selection, including the importance of a dynamic site database and the evolution of site performance, is essential for contract research organizations (CROs) aiming to conduct effective and reliable studies. The strategies and considerations in site selection continue to evolve, highlighting the importance of meticulous planning and strategic collaboration.
The Importance of Site Selection in Clinical Trials
Initiating the process with the creation of a potential site list equates to laying the foundation for a house. This critical step determines the study’s success, much like a solid foundation ensures a house’s stability.
Thorough assessment of potential sites for the study ensures their suitability for the research. This important step mirrors the importance of choosing the right location for a house. Just as well-chosen locations are pivotal, high-quality sites play a significant role in this process. They provide the opportunity to gather reliable data, which in turn, supports the precision and integrity of the study results.
Just as time investment in selecting the perfect site for a house is crucial, equal importance should be given to site selection in a study. The entire research structure is built upon this foundation.
The Site Selection Process
Site identification begins at an early stage, even before the award of the study.
1. Prefeasibility
At this stage, the study’s outcome is still unclear. In response to this uncertainty, potential sites are approached to evaluate their suitability for the study, all while upholding the highest standards of confidentiality. The site selection manager then actively seeks feedback about the study and an estimate of the number of patients each site could enroll. This valuable information is then used by the site selection coordinators who meticulously build a comprehensive site list and gather the necessary information, laying the groundwork for the study’s strategic plan.
2. Site Selection from Database
Site selection is a process that relies heavily on prefeasibility data and a well-stocked database. Over the years, information about these sites, including their preferences, performances, timelines, enrollment processes, recruitment sources, quality, past protocol deviations, and contact points are strategically archived. This invaluable knowledge enables the site selection team to target the right site for the study. With this expertise, the team is empowered to select the most suitable site from the database, supporting the success of the study.
3. Post-selection
The first 2 steps lay the groundwork for the third, which involves enriching our site list with public data. Past studies performed in the same indication are reviewed, if a site conducted more than 1 study in this indication, it may be deemed “experienced” and added to the list of potential sites.
4. Referrals
The fourth step is all about leveraging a network of site management organizations (SMOs) for referrals. High level, non-confidential study information is shared to gather accurate references. This process is instrumental in building the final site list to be contacted for the study.
Activation Process
The next step is initiated by contacting the selected site, which leads to a comprehensive assessment by site selection specialists. Each site is given the opportunity to complete a feasibility questionnaire (FQ), providing more detailed information. At this juncture, we share additional protocol information, including study requirements, timelines, and flow charts. This extra layer of information enables the site to provide more precise data in their FQ.
If a site aligns with the study, a site qualification visit (SQV) is conducted. In some instances, a site may be fast-tracked for selection based on its known attributes.
Once a site is selected, a notification is sent out, welcoming them to the study. The process then transitions to the site budget and contract specialists, as well as the project coordinators. Leveraging their extensive knowledge about the sites, these experts ensure that the sites are prepared and ready for a swift activation.
Performance Monitoring
Site selection is not the culmination, but rather a significant milestone in an ongoing process. Once a site is chosen, performance monitoring becomes paramount. This involves tracking recruitment performance, protocol deviations, queries, and adherence to timelines throughout the study. All pertinent information about the site is diligently recorded in the site database.
The process continues with a reality check, comparing the responses in the completed FQ with the actual performance. At this stage, reliable sites are identified based on their questionnaire responses. While some sites might overestimate their capabilities during evaluation, the site selection team pays particular attention to those that identify potential challenges in the FQ.
In the planning phase of a study, having reliable and credible sites from the outset can expedite the process. Trust in the information the sites provide allows the site selection team to proceed with them. However, for other sites, additional time to gather more context around the provided information is necessary.
Tracking is a key tool for insight identification and site selection. The continuous monitoring of sites to update the database is a daily task.
Evolution of Sites
Over a decade of collaboration with a site can provide valuable insights into its performance trajectory. However, a site that was once a top performer might experience a decline in effectiveness due to factors such as staff turnover, loss of experienced personnel, or overwhelming circumstances. Conversely, a site that was previously average could evolve and gain experience, transforming into a high performer.
Sites that show a decline in performance are flagged for close monitoring. Alerts are sent to the clinical research associates (CRAs), that are part of a collaborative team. Efforts are then made to address these concerns, with the site receiving necessary support and training. Temporary issues can often be resolved through feedback from CRAs, facilitating progress. However, if the issues persist, the level of collaboration with the site may need to be reduced temporarily.
On the flip side, sites that demonstrate improved performance may see an increase in collaboration. The importance of selecting the right, high-quality site for the success of the study cannot be overstated. It is important to keep in mind the principal investigator’s (PI) preferred and most experienced indications, the site’s access to a specific population, and that not all indications are suitable for every site. Therefore, matching the right site to the right study is of paramount importance.
Data Accuracy
An efficient site database is characterized by its dynamic nature, with information being continuously collected and updated throughout the completion of all studies. This dynamic approach enhances the expertise of a site selection department and allows for a close tracking of each individual sites such as their requirements, equipment, both in the present and the past, and will continue to do so in the future.
The daily work of a site selection team is centered around the relentless pursuit of identifying new sites. They are constantly on the lookout for experienced sites that can enrich their database. Their major sources for this search include conferences, public data, referrals, and SMOs.
As the field evolves, incorporating new areas of expertise and adapting to changing site dynamics will be crucial. Looking ahead, the integration of advanced technologies and data analytics promises to further enhance the precision and efficiency of site selection, paving the way for more robust and reliable trials.
About the Author
Faiza Tayar, B.Sc.
Faiza is a manager of site selection at Indero, bringing over 16 years of experience in the pharmaceutical industry. Throughout her career, she has held pivotal roles including senior site selection specialist, clinical research coordinator associate, data reviewer, and quality control specialist. Faiza’s expertise and strategic insights have been instrumental in not only shaping her own career but also significantly influencing the trajectory of Innovaderm. Her dedication to excellence and her ability to navigate complex clinical research environments have made her a key asset to her team and the broader organization.
