What's In a Name? Does it Really Matter if You Deliver Results?

Over the years, the title of the clinical research site or collections of sites has evolved, like everything in our industry. Twenty years ago, when research was almost exclusively conducted in academic facilities and teaching hospitals, it was pretty easy. Fast forward to 2010 and an array of titles:

* TMO (trial management organization)
* SMO (site management organization)
* ISN (investigative site network)
* Alliances of Research Sites
* Stand-alone Research Site
* Private Practice Research Site
* Hospital-based Research Site
* Academic Research Site

Let's look back at the evolution...

About 15 years ago, the concept of brining together groups of research sites (defined almost exclusively as physicians conducting clinical research within their private practices) to form an organization that would operate under one umbrella and one name led to the birth of the Site Management Organization. The idea had real merit - sites could come together and realize economies of scale in various administrative activities, offer industry consistency among sites and together they could all flourish, or not.

The SMO business moved forward at a swift pace, consolidating research sites and starting others from scratch when a need could not be filled by acquisition of a site. The good news was they were backed by deep pockets - their own and investors' - and they made a big splash! The bad news is that industry was not prepared to place the same study in multiple sites within any SMO because they didn't want to "put all their eggs in one basket." They were doubtful that they would find consistency among sites for critical activities such as enrollment, retention and quality - even sites within the same organization. And they had the mistaken belief that their access to the PIs would be limited by the SMO, a situation that I neither saw nor heard of happening. So those functioning as SMOs during that era decided if industry didn't like the term SMO, they would not refer to ourselves as such.

Hence the evolution to Trial Management Organization (TMO). I never quite understood the difference between an SMO and TMO. Mostly I recall being told by sites, "We won't get work if we refer to ourselves as SMOs so we'll just call ourselves something else." Some of us didn't like TMO and knew SMO wasn't going to work in our favor, so the idea of Investigative Site Network (ISN) came into play.

The big SMOs soon realized the money was not in being involved in the site world. It made more sense to become CROs and so they did. However, that still left many sites trying to figure out how to identify themselves. Interestingly, while the reaction to the name SMO was not always positive, the acronym was widely used and understood.

Time for Industry to Take a Fresh Look

But why didn't industry embrace the SMO model? What industry needs for successful clinical research are quality sites that operate and perform within the regulations and yet are nimble in their execution of studies. That brings me full circle to what's most important - a name or the ability to deliver results. When evaluating sites, the focus should be on the elements that are critical for success:

1. Is adequate trained research staff to fulfill the obligations of the study and the federal and local regulations?
2. Does the site have an appropriate number of potential study volunteers to populate the study?
3. Is there a detailed plan as to how the site will access these potential study volunteers?
4. Is there a plan and adequate personnel to retain study volunteers?
5. Is all the research staff educated and committed to human subject protection and study and regulatory compliance?
6. Is the site committed to the conduct of clinical research?

This last question could easily be the first question, because one thing SMOs do is to bring together research sites committed to being engaged in the process. When we know the turnover of research sites is so high (80% of physicians will conduct only one clinical study), we must find ways to keep physicians committed to conducting quality clinical research. By working with an organization that alleviates sites of some administrative burdens, we see more longevity among sites that belong to a group. With additional regulatory expectations and shrinking financial margins, this layer of service may very well be what sites need. Not to mention, a site joining an ISN/SMO makes a deep commitment to the process, deeper than just answering a questionnaire to conduct a study. In fact the SMO model may be just want is needed and should be given a strong look again by industry, not as a hurdle but as a partner.

SMOs from the Site Solutions Summit 2009 survey demonstrated they are a strong vertebra in the backbone of research sites. On average, SMOs conducted 30 studies in 2008; other types of sites conducted an average of 22 studies. Our survey also showed that 100% of SMOs employ SOPs as a quality assurance measure and 90% have an active auditing process. One of the most significant statistics shows how SMOs compared to other types of sites when it came to meeting enrollment goals in the last 10 studies they completed:

Hospital              55%
Practice               69%
Freestanding        94%
SMO                    95%

If top-performing sites are as good as, or in some instances even better than, other types of sites, is it really fair they're excluded just because of the name they use to refer to themselves? If they're so positive for the industry why then are they not invited to the table?

Growing up, my father would jokingly say, "It doesn't matter what you call me, just don't call me late for dinner." He seldom missed a meal, so maybe that simple directive helped to make sure he was always invited to the table. I'd say he had the right idea. Does it really matter if a site is under a network with regard to the opportunities it's offered?

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