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10 Steps to Clinical Study Startup: Step 1 - Identify Sites

by Jae Chung
16Nov2017

According to research from Tufts Center for the Study of Drug Development (CSDD), 37% of sites selected for clinical trial studies under-enroll, and 11% fail to enroll a single subject. Eventually, 89% of studies meet enrollment goals, but often at the expense of sponsors faced with doubling the original timeline due to poor enrollment.

10 Steps to Clinical Study Startup: Step 1 - Identify Sites

Other research cites slow patient enrollment as the top reason clinical trials are behind schedule.

Overall, poor site selection, the inability of sites to predict the rate of enrollment, and the subsequent need for study rescue may increase cost of trials by 20% or more.

Identifying high performing investigative sites is one of the most critical decisions made by a sponsor, it is a key driver in ensuring recruitment is completed on time and that the data is delivered in a timely manner with excellent quality. The process can be cumbersome and time-consuming for sponsors, as it requires them to evaluate current data on performance and patient accessibility, as well as, the future potential of sites to execute the study. Recruiting quality investigators and investigative sites directly correlates to quick subject enrollment, subject retention and quality data for any clinical study. When done well, sponsors and investigators provide better results not only for the study but also for the patients themselves who seek out and participate in the study. But this is typically easier said than done.

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Competition for trial sites, investigators and patients continues to rise. The changing landscape of clinical trial site selection and patient recruitment is attributed to increasing complexity of trial protocols, competition for patients in certain therapeutic areas, as well as, the changing regulatory requirements. According to recent research 80% of trials fail to meet enrollment timelines.

There are four common methods used to identify investigative sites. Sponsors often use a combination of these methods to quickly find the right sites for their clinical study. Each has varying effectiveness and some drawbacks.

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Finding & evaluating potential sites – Sources

Internal databases

Sponsors don't need to reinvent the wheel for every new clinical study. Sponsors already have internal databases readily accessible and prepopulated with sites that they've worked with in the past. Maintaining an internal database helps sponsors cultivate long-term relationships with sites that have performed well and that they would like to use for future studies.

One drawback is that sponsors need to actively maintain their database. Manually entering new data and tracking changes to the database gets even more labor intensive, and prone to errors, as the database becomes larger.

While an internal database provides a great starting point for established sponsors, the data is limited and sponsors often need to expand their list of investigative sites for a new clinical study. Many investigators do not return to conduct another clinical trial. According to a recent CenterWatch study, investigator turnover rates have reached 35 percent in the United States and 55 percent in Europe. This makes it difficult to gain transparency with regards to who will perform well in your study.

Institutional knowledge is frequently dated and siloed (shouldn't sites be evaluated on recent performance?), and may not be relevant to the disease and/or indication under investigation.

Generally, internal databases are not comprehensive enough to support larger studies and often don't reflect current data. In addition, these databases only provide data on sites that have already worked with the sponsor leaving a gap of new sites unknown to the sponsor (for the typical multicenter study 30% of sites selected are new.)

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Contact a CRO

Engaging a Contract Research Organization (CRO) as a development partner is a common industry practice for sponsors when starting up clinical studies (outsourcing of trials estimated is to exceed 70% by 2020.) CROs can provide a wide range of services to sponsors including site identification. CROs that provide site selection services also provide their own list of investigative sites. While CROs help identify sites, there are important distinctions to consider.

Larger CROs generally have a wide-breadth of expertise and capabilities to handle multiple indications and service the sponsor. However, their list of sites may be out-of-date because they are spread across multiple indications.

Smaller, niche CROs typically have a more focused and up-to-date list. However, because smaller CROs are niche providers, many of their sites may already be dedicated to other competing studies.

Peer Referrals and KOLs

Key Opinion Leaders (KOLs) are professionals with firsthand knowledge and experience working in a particular indication and will be sought out by their peers for advice and clinical care directions for their own patients. Due to their significant interaction with their peers, KOLs can provide referrals of investigators who have patient populations and skills to execute the study. In addition, the selection of a well-known KOL will help to provide incentive for other sites to join the study based on the sponsors finding a KOL by scouring scientific publications, conference agendas and professional blogs. While having a KOL on your study is a good thing one must consider that KOLs tend to have large practices and will be sought out by many sponsors which may leave them with a challenge to enroll patients and collect data in a timely manner for your study. You must determine if the benefit of the KOLs influence is greater than the need for patient enrollment at their individual site for your study.

Current sites may also be a good source to tap when trying to identify new sites. Most sites will refer other sites to a sponsor that can accommodate a clinical study.

Physician Directories/Registries

Sponsors utilize both online and offline directories to identify sites and cast a wide net for site nominations and selection. Some online directories allow sponsors to search for sites free of charge, while others require a fee. Directories can be large and help sponsors exposure to sites that they were not aware of previously; however, ability to judge the quality of the sites remains a challenge. Sponsors will need to spend more time researching the quality of each new site – a labor intensive and time consuming process. Since many directories are static and not regularly maintained sponsors may be receiving data, which is not relevant at the time they need to make a decision on site selection.

Closing thoughts

No matter the list or database used, it is critical to know how often the content is updated. Principal investigators and sites change, and their areas of research expertise and site capabilities can also fluctuate. The utilization of the information from registries/directories is a starting point in the selection process and is enhanced when combined with internal and external information about site performance and patient populations, yielding the best results.

10 Steps in Clinical Study Startup

Jae Chung
JAE CHUNG
Founder and President
goBalto, Inc
"The process of conducting clinical trials is often long, complex, bureaucratic and, above all else, expensive. There has been a strong focus on study conduct and quality, but as stakeholders are increasingly aware that better study startup processes are linked to shorter clinical timelines, the emphasis has been shifting in that direction. Leading life science organizations are driving the adoption of this innovation by automating a cumbersome industry process, with the goal of getting medicines to those in need faster."

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