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 clinical trials, which are not only long and bureaucratic, but are also experiencing diminishing returns.
Key to reining in budget overruns and delays, often resulting in 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 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.
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.
According to Tufts CSDD 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.
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. And perhaps most disturbing is the fact that cycle time has not changed in more than two decades.
Sponsors and CROs, often lack a transparent, evidence-based strategy for this task. Instead, they frequently rely on archaic paper-based or spreadsheet methods to identify sites across the globe with a reasonable chance of enrolling the contracted number of patients on schedule, and the ability to generate quality data.
What criteria can be used to help optimize site selection?
Ten tips for selecting investigative sites ideal for your trial:
One of the biggest factors contributing to lengthy cycle times is the inability of sponsors and CROs to engage investigative sites in a manner that supports effective patient recruitment and retention.
In practice, site engagement is a critical success factor in clinical trials and these tips should be considered when conducting site feasibility assessments and the pre-study visit (PSV), a critical event that sets the stage for an open, collaborative relationship to last throughout the study – imperative to the overall success of a study as many crucial tasks are accomplished during these visits. Getting these ten factors right could eliminate or reduce the need for extensive surveys and pre-study visits.
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.
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