The life sciences industry is riddled with casually used terms, acronyms and phrases which are often used out of context or defined differently among companies or individuals. This becomes especially problematic when developing and designing clinical trials, as terms that are tossed around as ‘givens’ can be much more complex processes that may dictate success or failure of a clinical trial.
Take for example the phrase “site selection.” The way our industry refers to site selection is often a misleading concept. In the age of “big data” and artificial intelligence, we need put qualitative and quantitative meaning behind such terms, which is what we’re doing at Phesi. For example, when we analyze and recommend the best, top-performing investigator sites to our clients, our platform can filter important details about individual investigators at every site. Why is this important?
Sometimes, when we are looking for a good investigator at a particular site, (s)he may refer us to a colleague. On the surface, there is nothing wrong with this practice, since both investigators are at the same site, and we are selecting “a site”. But this kind of referral is often the first step toward poor performance, or worse, a non-performing site. In our experience, most sites have only a small percentage of investigators who are skilled and consistently outperform in clinical trials, even in the most prominent global sites.
Strictly speaking, a site is a place. It is a term that can be applied to a clinical center, an institute, a hospital, or a neighborhood clinic. Massachusetts General Hospital is a well-known site, but a primary care clinic a few blocks away can also be a site. We do not work with the place that a site occupies, but with the people at the site. Typically, site sponsors work with one, or sometimes two or more principal investigators, as well as with clinical research coordinators (CRCs), or clinical research associates. Some trials may also involve one or more sub-investigators at a given site.
For those intimately involved in site interactions, it is often hard to tell which personnel are the key drivers of success in a particular clinical trial. Success may hinge on an experienced and capable CRC who coordinates all aspects of the trial, or it may be a sub-investigator responsible for enrollment performance. However, in most cases the principal investigator is ultimately accountable. A successful investigator knows where and how to recruit, cultivate, and retain high-quality CRCs and sub-investigators, and how to empower them to deliver good results.
In many countries it is not uncommon for an investigator to be affiliated with several sites. Even in countries where investigators are attached to a single site, an investigator with high potential often has an established network of sites that provide a pool of qualified patients. In such cases, the investigator decides which site to designate as the primary site, and which will be the secondary or tertiary site(s).
In this context, it is clear that we are selecting an investigator, not a site. This is a process illuminated by our AI-driven predictive analytics platform, which facilitates selection of the best performing investigators at the best performing sites. Without this intelligence, it is nearly impossible to establish a common language and implement successful clinical trials.