Jimmy Durante Was Right

Jimmy Durante had a repertoire of famous phrases (“ha cha cha” comes to mind), but in thinking about clinical research, the phrase that recurs is “Everybody’s gettin’ inta the act!” Our industry is both blessed and plagued with new businesses every month new SMOs, new CROs, new software players, new service or product niches we didn’t know we needed.

We are blessed because sometimes these companies represent at least the possibility of innovation, in a business sorely in need of new ideas. (Actually, there are plenty of new ideas; we need people to start applying at least some of them.) We are plagued by these new companies sometimes, often by their evanescence, and almost always by their incompleteness. They can be incomplete in their thoughtfulness (as evidenced by products or services brought out too early or with too many holes), in their business infrastructure (they are usually undercapitalized, under-staffed and overpromising), and in their market understanding (for which, while annoying, we can be more forgiving, because they will learn quickly or die).

One of the curses of the state of software today, for instance, is one of the most important developments in that industry: tools for rapid application development (RAD). To some extent, this leads to a situation in software development not unlike the curse of desktop publishing tools or consumer video cameras. The tools are “so easy” to use that anyone can use them, and unfortunately, anyone does. The results in document design and home videos are known to us all; in software, the “ease” of RAD leads to products in tradeshow booths whose flaws may be less obvious.

What this means to the clinical research professional is that ever more care and diligence must be taken in examining new technologies to serve us a fact that co-exists with our ever accelerating need to adopt information technology to improve our trials processes. Those of you specializing in studying these technologies for your institution will play an increasingly critical role as you help sift through the new products and services being offered.

Internet-related products will certainly be a focus in the coming months for this kind of hopefulness and appropriate skepticism. Many vendors or CROs are hurrying to bring out “Web-enabled” versions of their products, reports, communication tools, or other services. Many sponsors are equally guilty of exhorting their staff to “do something with the Internet” this. Some of these products and services will be very valuable; others will be only “web-dressing”. How do you tell the difference? By following the same analytical means described in earlier columns:

Consider your needs first; not the vendors’ features

Examine the vendors’ vision and intent as much as their products

Study their business infrastructure as much as their brochures

Test their flexibility in working for your needs

Test their understanding of how their product or service will impact the daily work of your organization.

Can SMOs Afford to be SMOs?

I have similar concerns about service providers as I do about software vendors. Site Management Organizations (SMOs), in theory, should be able to offer significant advantages to the clinical research process: accelerating study startup, simplifying contracting and communication, ensuring more professional sites and thereby cleaner data, and more. Not the least benefit of SMOs should be the pressuring of CROs out of their complacency and into a clearer definition of their unique value to the process.

But these benefits are not yet obvious to the bulk of the sponsor community. Success stories are isolated or sometimes harbored for competitive advantage; in other instances, the benefits objectively have not been demonstrated. Meanwhile, it remains uncertain how SMOs make money, and how they will find their way to a business model able to reward the aggressive expectations of their investors.

This relates directly to information technology. SMOs are operating in a narrow space between investigators, CROs, sponsors and investors, and only by proving their value will their companies gain in value. One of the most important values an SMO can bring to the clinical research process is the creative application of information technology for trials management, patient recruitment, study documentation, and clinical data capture. By being an administrative layer intimate with the site the heart of clinical research the SMO can gather and deliver information of unprecedented usefulness to create sorely needed efficiency in trial conduct and project decision-making.

But very few SMOs are making the commitment to information technology to make this happen. They talk about it, sometimes sincerely, but have been hard pressed to make the investment. It does cost something to create the IT infrastructure that brings this value. And considering the economics of trials as managed today, we have to ask, “can SMOs afford to be SMOs?” Can they afford to deliver the value they have in their grasp? The answer to this is critical for sponsors to understand, and for all those forming the latest SMO-of-the-month.

Jimmy Durante also used to say, with a tip of his hat and a gleam in his eye, “You ain’t seen nothin’ yet!”. To a disappointing degree, we’ve seen a lot of nothing from new companies (or new products from old companies). Let’s hope Jimmy was right, and we will see real value being offered, and have the wit to recognize it when we see it.