Clinical Trial Site Identification Solutions

Selection of appropriate clinical trial sites is an important factor for a successful clinical trial.[1] Site identification involves evaluating potential sites to pre-select those that meet specific criteria and have the necessary resources and expertise for efficient study execution and accurate data collection.[2] Traditionally, site selection (including the prior step of site identification) and activation has been a major source of delay in clinical trial start-up.[3] Beginning by defining a comprehensive clinical trial site selection checklist (clarifying priorities for the specific study) is a smart way to streamline the process and quickly identify sites that are a strong potential match.

In this article, we will examine prominent factors to consider in site identification, provide tips on how sponsors can identify sites that match their needs, and offer solutions to streamline the site selection process.

How to find sites and gather initial information

The first step in clinical trial site identification is gathering preliminary (basic) information about sites, which will allow you to assess whether they may be appropriate for your clinical trial. In order to begin, we need to know how to find sites in the first place. Fortunately, there are many sources that clinical trial sponsors can use to find and gather information about clinical trial sites.

Use clinical trial databases and registries

Several clinical trial databases and registries can help you identify potential trial sites. Examples include clinicaltrials.gov and various disease-specific registries.[4] Besides information on trials, these sites also provide information about investigator profiles and site capabilities, allowing you to gather initial data on potential sites.

Power is one of the leading aggregators of clinical trials, and stands out for its user-friendliness and transparency. Power is an authoritative source of information for clinical trial sponsors embarking on site identification.

Leverage clinical research organizations (CROs)

CROs offer various support services to clinical trial sponsors, including help with site identification. Better yet, many CROs have extensive databases or networks of sites, making them a valuable resource for sponsors during site selection.[5]

Site management organizations (SMOs)

SMOs are organizations that specialize in site management services for trial sponsors.[6] They often have a network of investigators and sites that they commonly work with, and are thus well-positioned to help sponsors identify sites that are suitable for their trials. Further, they can also help in the management of sites during trial operation, serving as a great resource for sponsors looking to outsource to a greater degree.

Leverage recommendations

Professional associations and societies in specific therapeutic areas can offer valuable resources for site identification. They often maintain directories of active clinical research members and partners, which may help sponsors identify potential trial sites and investigators.

Reach out to key opinion leaders (KOLs) and subject matter experts in the therapeutic area of interest, who may be able to provide valuable recommendations of high-quality trial sites that are proficient in the specific therapeutic area of the trial. Engaging with KOLs can also help establish collaborations and build relationships with highly regarded institutions.

5 tips for evaluating sites

Site identification can be challenging as there are lots of parameters to take into consideration, and site responses to site feasibility questionnaires (SFQs) often don’t entirely align with their real capabilities. The following tips are designed to help you effectively assess the most meaningful metrics to come up with a list of high-quality potential sites.

1. Consider the patient population

One of the biggest problems that clinical trial sponsors face is patient recruitment.[7] Since recruitment is usually tasked to the site, high-quality sites will have effective and efficient internal recruitment strategies. An important aspect of this is the site’s patient population, i.e., the network of patients who are connected to the site in some way or another, for example previous participants, those in a patient database, or the local demographic. If the study requires access to specific/specialized patient populations, ensure the site has access to such participants. Consider the site's experience recruiting similar patient populations and their ability to retain participants throughout the trial. A site with proven recruitment and retention strategies will help ensure the timely completion of the study.

Additionally, research suggests that site access for patients is key to the clinical trial's success.[8] Therefore, it may be a good idea to assess the site for accessibility to the desired patient population. Selecting sites with the necessary resources and patient networks can streamline recruitment efforts and accelerate study start-up.

2. Evaluate investigator experience

The experience and expertise of the site’s principal investigator is another important factor. Evaluate the principal investigator's track record in conducting clinical trials, their knowledge in the therapeutic area of concern, and their understanding of the study protocol.[9] Potential proxy indicators can also include their publication history and participation in relevant conferences. Investigators with a strong background in the specific therapeutic area are better positioned to support the trial's success.

3. Consider the site’s infrastructure and capabilities

Ensure the clinical trial site has the necessary physical infrastructure and resources to support the study. Evaluate their facilities, equipment, and access to any technologies required by the trial protocol. Adequate staffing, including trained research coordinators and data management personnel, is also essential for efficient data collection and management. Staff training records should be up-to-date and demonstrate proficiency in the various aspects of trial operations.

Assess the site's capabilities to fulfill protocol-specific procedures, such as any laboratory testing or medical imaging, and confirm their ability to handle the anticipated volume of trial participants.

4. Make sure the site is compliant

Verify that the site is up to date and compliant with local regulatory requirements. This could include checking staff training records, the presence of up-to-date SOPs, and demonstrated adherence with good clinical practice (GCP) guidelines. Review the site’s history of audits, regulatory inspections, and any past compliance issues - and how they were resolved. A strong track record of regulatory compliance supports trust and confidence for the sponsor when outsourcing trial operations to the site, and indicates a lower risk of protocol deviation/non-compliance, and added assurance of patient safety.

5. Be sure to visit the site

Establish open communication with potential trial sites. Discuss study requirements (technical and operational), expectations (of and for both parties), and any specific considerations, including budget, in open dialogue, which will help ensure mutual understanding and clarity. Plan a site visit to gain firsthand experience of the site's operational proficiency, meet the investigators and staff, and evaluate the site's facilities - including considering how comfortable patients may be in the space.

Engaging in discussion is important for addressing any concerns or questions and ensuring alignment between the sponsor's expectations and the site's capabilities.

4 solutions focused on clinical trial site identification

Although clinical trial site identification can be a long and complex process, there are several solutions and tools available to help streamline the process. The following strategies, tools, and resources can be used by sponsors to help identify and evaluate suitable clinical trial sites.

IQVIA Site Selector

IQVIA, a leading provider of integrated information and technology solutions in clinical research, offers IQVIA Site Selector, a comprehensive tool specifically designed to assist with clinical trial site identification.[10] Leveraging vast datasets and analytics capabilities, IQVIA Site Selector enables sponsors to identify potential trial sites based on specific criteria such as patient population, expertise in the relevant therapeutic area, site performance, and geographical considerations. This solution provides valuable insights to support informed decision-making and streamline site selection.

Electronic health record (EHR) query tools

EHR query tools have emerged as powerful resources for clinical trial site identification and selection. These tools extract anonymized patient data from electronic health records, allowing sponsors to identify potential trial sites with access to relevant patient populations. By analyzing data from EHR systems, sponsors can gain unique insights to better understand patient demographics, disease prevalence, and treatment patterns, enabling more targeted site identification and selection.

Digital platforms for site identification

There are reliable digital platforms that leverage real-world data (RWD) to provide targeted clinical research support services including clinical trial site identification and feasibility assessment. Platforms like TriNetX and Clinerion provide comprehensive data on patient populations, disease prevalence, and trial site capabilities and past performance.

These platforms can simplify site identification, and may represent a particularly attractive solution for sponsors looking to leverage the potential of RWD and advanced analytics but without assuming the new task internally.

Real-world data analytics

Real-world data (RWD) analytics involves analyzing real-world data obtained from various sources, including EHRs (see above), databases, insurance claims, and wearable devices, to name a few. Such data can provide perspectives on patient populations, treatment patterns, disease demographics, and potential trial sites with access to the desired patient population.[13] There are many potential sources and uses of RWD, and the possibilities are ever-expanding, so exploring this emerging field may be a good strategy for sponsors who wish to stay competitive as the clinical research landscape continues to evolve rapidly.

Bonus: Skip the site selection by adopting a decentralized or virtual trial model

Advancements in technology have opened up opportunities for “virtual trials,” also commonly known as decentralized or remote trials. Such trial models leverage various technologies such as remote monitoring, direct-to-patient drug distribution, telemedicine, and wearable devices to deliver and administer study drugs, collect data, and engage with participants in ways that move away from the traditional model of on-site, in-person study visits.[14],[15]

By embracing remote technologies trial capabilities, sponsors can either eliminate the need for trial sites entirely, or can expand their options for site selection by opening up access to a broader geographical space and removing the restrictions associated with frequent travel to the study sites. There is also the option to work with “virtual sites” (which could be CROs or other providers) that may not have a physical presence, but which possess the necessary infrastructure and patient access for assisting sponsors with conducting trials remotely, effectively fulfilling the role of the site in terms of liaising between the sponsor and the patient, but without the physical location and associated requirements.

To conclude

Selecting the right clinical trial sites is critical for successful study execution. Implementing the solutions we have described in this article can help streamline and facilitate the process of identifying potential sites that may meet your study's specific requirements. Consider leveraging one or more of the site selection solutions to make thoroughly informed yet quick decisions, which has the potential to decrease start-up cycle times. Nonetheless, identification is only the first step in site selection; be sure to engage sites thoroughly and verify their capabilities first-hand before signing CTAs. Finally, be aware that some studies are particularly suited to remote and decentralized trial models, wherein the traditionally slow process of site selection can sometimes be obviated entirely.