Waiting for Bill

Ambivalence may be one of the defining words of the late twentieth century. And it is particularly appropriate in describing the feelings of many clinical research professionals towards using computer technology in their work. We know we need to use it, we know it’s going to be great some day, but we wish it wasn’t so hard to get there.

At recent industry meetings, including The Executive Forum on Technology held in March, participants have expressed this ambivalence loud and clear. And ambivalence, as a psychologist knows, leads to frustration, anxiety and inaction.

If we divide, in a simplistic way, the universe of site-oriented clinical research software into two large constellations — trials management and electronic data collection — the ambivalence is clearly stronger regarding the latter. This is not to say that the choice of trials management IT solutions is clear (it depends entirely on each organization’s needs), but rather that there is considerable agreement on what functions need to be automated and integrated, and how. The primary questions in this constellation are: what platform do I use for trials management (the Microsoft products, Lotus Notes¢ç, Oracle)?; and do I adapt off-the-shelf applications or build my own on top of application development environments? Bruce Schatzmann describes the approach his company’s product takes in the first article following.

Ambivalence is much greater in the area of electronic data collection. One need only survey the many different processes sponsors have used to employ EDC (forgetting about the different technologies for a moment). Should data be entered directly into the computer at the bedside? Should the coordinator enter it daily or weekly? Should the sponsor or CRO’s CRA enter the data at the site? At the office? Can patients enter their diary directly?

Each player in the EDC process chain also has his or her ambivalence. The sponsor worries about putting “yet another” PC on their investigator’s desk. The CRO doesn’t want to do anything their customer might think is too innovative for their trial, or that might burden a trial on which margins and deadlines are already tight. The site is nervous about investing in its own technology for fear the customer will not approve. The article following from Quintiles tells us one story of “RDE caution”.

And yet, at the same conferences alluded to previously, it is clear that it is no longer a question of “should we” use EDC but “when” or “how”. The issues are not easy, and yet several large sponsors are now quietly making significant investments in EDC technology. And the large site networks are closely examining the process, quality and cost benefits of using “electronic source document” to empower their businesses.

When ambivalence reaches a peak like this, often we all wish “someone” would solve this dilemma for us. This syndrome I have called “Waiting for Bill”, as in Bill Gates. I’ve heard more than once the wish that Microsoft would come in to the clinical research arena with some dominant, cheap (partially annoying and undoubtedly buggy) product which would solve this ambivalence for us. It is tempting, and may yet happen; this issue is attracting business interest. In a more modest manner, the article by Rebecca Kush suggests how important it is for the industry to try and establish some standards in this area.

I suggest that each of us must evaluate, develop and implement technology solutions that provide tangible, short-term benefits within our own worlds, and try to solve the universe’s problems to the extent we have the time, goodwill and resources to do so. By all means, we need to avoid choosing solutions which one can easily predict will run afoul of a more standardized universe (choosing an obscure programming language, or a product architected for the wrong industry, for instance). The use of technology in this way is “self-justifying”, and at least in the short-term, does not depend on Bill or anyone else to decide how we are going to do our work. While we are waiting for Bill, the world will pass us by: other companies will beat us to market, other investigators will win the opportunities to research tomorrow’s therapies.