Site selection is a pivotal phase in the planning of clinical trials. The right sites ensure timely recruitment, high-quality data, and overall study success. To make informed decisions, leveraging multiple data sources is essential for maximizing opportunity and mitigating risk.
Evaluating sites from all angles
Sponsors and CROs rely on a variety of data sources for site selection, including:
- Commercial investigator databases. Numerous commercial databases are now available to facilitate site identification and investigator outreach, though these databases vary in quality and may not be either comprehensive or up-to-date.
- Patient demographic data. Information on population size, disease prevalence, and patient availability helps in identifying regions to target and estimating the potential pool of eligible study participants.
- Healthcare infrastructure. Data on a site’s capabilities, equipment, personnel, standard of care, and standard operating procedures aids in assessing site feasibility and readiness.
- Historical performance. Previous clinical trial performance data, such as recruitment rates, retention, and data quality, helps identify reliable sites.
- Geographical data. Geographic information systems can be used to provide intelligence on site accessibility, transportation networks, and proximity of patients to potential sites, which is critical for understanding logistical considerations that might impact recruitment and retention.
- Patient associations and advocacy groups. These organizations have established networks and strong community ties, both of which can facilitate outreach and education efforts. They can provide not only demographic and geographic data, but also deep insights into patient experiences, treatment preferences, and barriers to study participation. Moreover, advocacy groups often collect and manage patient registries or databases that contain real-world data on disease prevalence, treatment patterns, and outcomes. This data can be instrumental in identifying sites and trends that might affect site performance.
Why a multi-faceted approach matters
- Comprehensive analysis. Different data sources each provide unique insights and collectively offer a holistic view of the universe of potential sites. For example, patient demographics data reveals the availability and geography of eligible participants, while healthcare infrastructure data sheds light on a site’s capability to meet protocol requirements.
- Risk mitigation. Diverse data points help uncover potential risks and challenges that may not be apparent when relying a on a single source. For instance, historical performance data can highlight sites with poor recruitment rates in previous similar studies, but bear in mind this doesn’t always take into account the reasons for poor performance, such as COVID impact or changes to country-level regulations.
- Enhanced decision-making. Combining and cross-checking data from various sources increases the accuracy and reliability of predictions and models, leading to more informed decisions.
Putting it into action: A case study for site selection in rare disease
A sponsor engaged Premier Research to assist with the conduct of a rare disease study in a pediatric population. Premier’s global team performed an initial search utilizing commercial data sources to identify countries to target for inclusion in the site selection process. Spain was one of the countries that was excluded from pre-selection due to lack of documented clinical trial experience in the indication. Follow-up outreach to investigators in Spain seemed to confirm that there was only one physician treating the rare disease, so the sponsor was informed that Spain would not be included in site selection.
However, Premier performed further research into patient associations and advocacy groups and initiated conversations with the president of the patient association in Spain. We introduced the sponsor to this association president, and they engaged in productive interactions about the study inclusion/exclusion criteria, endpoints, and assessments. This led to changing the protocol to allow younger children to enroll in the study.
In addition, the association met with parents to promote study awareness and provided Premier with both referrals to treating physicians and data on the number of potentially eligible patients in each region of Spain. Using this new intelligence, Premier was able to open sites in Spain according to the locations of treating physicians and patients and to facilitate study logistics for patients who lived distant to those sites.
Taking advantage of every data source
The optimal approach to site selection is unique to each study. Often, especially in rare diseases, successful site selection is reliant upon a combination of data sources and recruitment tactics. While commercially available data sources serve as a good starting point, comprehensive research and creativity are essential for maximizing the opportunity to identify qualified sites where patients either are already being seen or could be referred to for clinical trial participation.
To learn more about key considerations for selecting the right clinical trial sites, click here.