10 Criteria to Aid in the Selection of Investigative Sites
2 May 2017 by Craig Morgan, Head of Marketing, goBalto
Investigative sites are the heart and soul of clinical trials, essential to ensuring the efficacy and safety of pharmaceutical compounds in humans. Site selection is pivotal to the successful execution of trials, which are not only long and bureaucratic, but are also experiencing diminishing returns. Studies estimate that it costs upwards of $2B dollars to bring a new drug to market, with daily revenue losses in ranging from $1M to $8M due to delayed market entry.
Key to reining in budget overruns and delays, often fueling the growing rescue studies industry, is the selection of high performing sites that are ideally suited to running the study under investigation. The selection process is, however, often manual, cumbersome and error prone.
The numbers tell a sobering tale.
According to research from the Tufts Center for the Study of Drug Development (CSDD), 37% of sites selected for 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.
The industry has responded to these issues by engaging more sites than required for trials, in anticipation that some of these sites will underperform and may subsequently will be dropped. This dubious business practice has fueled a lack of trust and transparency between sites and sponsors/contract research organizations (CROs) and needlessly increased costs and timelines.
About 40% of investigators each year choose not to conduct any further clinical trials, at a time when typical multi-center studies require 30% new investigative sites, and the clinical research industry is experiencing a concerning global shortage of experienced clinical research associates (CRAs), professionals whose main function is to monitor clinical trials.
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. And perhaps most disturbing is the fact that cycle time has not changed in more than two decades.
So, what criteria can be used to help optimize site selection?
1. Investigative site infrastructure
Does the site have the required infrastructure needed to fulfill the requirements as specified in the protocol?
2. Experience of site staff
What staff (and what is their level of experience) does the site have on-hand to monitor the trial and ensure compliance?
3. Past performance of the site with clinical trials (of related size and complexity)
Having a deep keel is important. Experience is relative and a sites past experience should always been reviewed to ensure that their recent performance is on par with historical results.
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4. Affinity of the site to the target disease under investigation
Sites that specialize in the target disease under investigation are less likely to experience difficulties implementing the trial protocol.
5. Disease target population proximity to the site
Selecting sites that are in close proximity to subjects with the disease target under investigation is a factor to consider with regards to how quickly the site anticipates to complete enrollment.
6. Enrollment of subjects. Have they previously met their enrollment targets?
Provides an performance indicator and potential validation of site enrollment claims.
7. Startup cycle times lower than industry benchmarks
What cycle times can the site provide? What cycle times do they measure (e.g., Site activated to enrollment cutoff)? Are these on par or better than industry benchmarks?
8. Has patients in target disease under investigation
Does the site currently treat patients for the disease target under investigation? If so, how many? And would they be prepared to enroll these patients in the trial?
9. Has the Principal Investigator (PI) published on the target disease under investigation?
A thought leader with connections acting as a site advocate will ensure timely engagements and commitment to the study, and may be a source of other potential sites of interest to contact.
10. Does the site embrace a process of continual innovation?
Does the site perform post-mortems on studies to gauge areas for process improvements? What new processes/systems have they recently adopted?
These tips should be considered when conducting site feasibility assessments and the pre-study visit (PSV), critical events that set the stage for an open, collaborative relationship to last throughout the study.
Optimizing site selection results in a strategic operating model, where teams act as a united front with shared goals and aligned structures and processes. This translates to increased resource productivity, cost savings, and ultimately, more successful studies.
Craig Morgan is a technology and life sciences management professional with more than 15 years experience in the application of informatics and bioinformatics to drug discovery. He currently heads up the marketing and brand development functions at goBalto, working with sponsors, CROs and sites to reduce cycle times and improve collaboration and oversight in clinical trials. Craig can be contacted at email@example.com.