It’s baseball season again and I can’t help but use a baseball metaphor to highlight two disturbing trends in clinical IT adoption. Consider base running: the art of it (after hitting the ball in the first place), is to run “through the bag”, i.e., don’t slow up as you get near it so you can be thrown out by a strong infielder, and don’t overrun the bag so that you get picked off for going too far. Many sponsors are in danger of both errors, on the same play, by thinking too far ahead while not finishing the work they have already started.

How does this metaphor apply? Our current shortfall in successfully implementing useful and reliable clinical IT applications is a failure to run through the bag: we buy the software, we design an incomplete implementation, we run out of funding just short of the end – out at first base! Now think of the time you or your strategy staffers are spending dreaming of the intersection of pharma research and the world’s infant-state electronic health records: you just overran the base – out at first again!

Stopping Short

Despite what many executives might have been told, or senior middle managers sincerely believe, the usefulness and reliability of many clinical IT installations (EDC, CTMS, AES, ePRO, data warehousing) is consistently disappointing. It’s not to say that these applications and services are not working, or even that sponsors are not deriving value from them. But the shortfall between promise and potential on the one hand, and actual execution on the other hand, is remarkable. There are many examples:

–Adverse event systems whose report programming is still too complex

–ePRO instruments which take too long to translate into multiple languages

–EDC vendor project managers who understand little about clinical trials or the account they are serving

–Document management tools which require weeks of training and legions of “super-users”

–Clinical operations departments using multiple tools with pieces of the same data entered over and over again

–Safety departments who don’t trust their AES tools

–EDC users who simply buy the vendor’s services and change nothing internally, and are surprised that things go wrong.

The use, or disuse, of enterprise CTMS systems is probably the most egregious example. Walk into any company using a large-scale CTMS application and the refrain is the same: “yes, I enter data into the application every Friday like I am supposed to…but do you want to see the Excel spreadsheet I programmed that I really use to run my trial?” That enterprise CTMS in a big company cost hundreds of thousand of dollars and staff hours in configuration and training – why aren’t people using it for real work? Because these applications, originally conceived with good intentions, have long since left operational reality behind. Part of it is because it is so hard to develop a single program for trial management which meets all the diverse needs of the industry. Part of it is because the enterprise tools are all based on something other than clinical research: sales force automation, managing construction projects, financial portfolio management, investigator site payables, or generic workflow mapping. But ultimately it is we users, as purchasers of these tools, who allowed such disappointing outcomes. Examine how you are using your CTMS now, and compare it to the demo you first saw, or the requirements you first developed. Isn’t it remarkable that such an expensive and complex product does so little for you, after all that time and money?

Data warehousing and mining, the successor to our CDMS’ across the industry, is another example of clinical IT anticlimax. Go behind the conference presentations and you will find that little evidence of truly successful and complete data aggregation and data integration that these projects originally promised.

Indeed, there are so many examples that it makes one wonder whether there are inherent flaws in the thinking behind our clinical IT projects, or in their management, or in the vendors supplying software and services for them. Some common flaws come to mind:

–we do not know how to balance conflicting needs on the basis of operational practicality instead of team politics

–we do not budget sufficiently so that the project can “run through the bag”, so that we can’t afford the cost of configuration and training, and fixing mistakes and re-training

–we are impatient with multi-year projects and we are running too many such projects simultaneously

–we don’t dedicate to the project our best staff polymaths, who have the essential combination of operational, technical, interpersonal and leadership skills to keep the project focused and see it through.

What is common to both the CTMS and data storage stories is highly instructive: value has been derived, and good things have come from these projects, but in deep disproportion to the investment required. The most successful of these implementations recognized at some point (consciously or not) that, for instance, just getting everyone’s opinion on the investigator’s address and phone number in one single place in the enterprise is a useful step forward. Or that being able to make the simplest query across multiple EDC standalone trial databases begins to make up for killing off the CDMS dinosaur.

Success is in Simplicity

In the present state of clinical IT, vendors must supply, and users must demand, more business-useful functionality and improved levels of service. At the same time, the end-users who I am idolizing here are also responsible for the fix they find themselves in. As we try to get the most out of what we have, users must understand that simplicity is powerful and preferable.

We will get much more satisfaction from our service and software vendors if we are able to articulate clearly a reasonable set of functionality. We observed a project recently where a sponsor properly chastised a CTMS vendor for providing an unwieldy, complex tool for report generation. The sponsor proudly announced that they had taken matters into their hands and whittled down their trial status reporting needs to 48 reports! Forty-eight reports! Not a single biopharma employee on earth will read through, keep track of, learn from, or benefit from 48 tracking reports. It is this kind of sponsor-vendor interaction which led to the overly complex software and services we have in the first place. If you cannot manage your clinical trials by tracking far less than even a dozen parameters, you need to revisit your management skills.

Indeed, simplicity is at the heart of many of the problems we have described. If we aim for the fewest patient-reported scales, the best recruiting sites, the fewest fields with the minimum of edit checks on our eCRFs, the “vital few” metrics on CRO performance, then we will have a chance of a) getting a reliable tool or service to deliver what we need; and b) be able to execute our trial programs with greater efficiency and speed. Fewer sites to monitor, fewer datapoints to process, fewer vendors or CROs to manage – these all lead to better operational performance.

Take Back the Dialog

One thing that is clear is that many of those specifically charged with leading the future of clinical IT have left these problems behind them. They have run past the base in their enthusiasm for the “next big thing”, as if the shortfalls described above do not matter or are not recognized. They are chasing electronic medical records, ubiquitous wireless Internet, Web 2.0, SaaS, iPhones, arcane analytics, and every other technical trend. Yes indeed the future lies there, or beyond, and someone should be looking. But perhaps not quite so many of us. You cannot leave this generation’s work undone; if you do you will do just as bad a job when the next big thing shows up.

Our futures are being described by (and therefore, are in the hands of) those who are bored with EDC, CTMS and the traditional clinical IT niches. I will always remember the informatics VP of a big, famous pharma (no longer employed there!) who, having done one EDC study, said “OK, we’ve done that, what’s next?”. Funny, except he was serious, and he controlled the purse-strings. Users must take back the dialog from folks like these. Users are not bored with reliability, with applications that automatically generate the reports they need and make it easy to specify new ones ad hoc, with aggregation of disparate data sources into a single database for their clinical trial, or the integration of their existing, underused applications. There is so much to be done: a Grand Vision is not needed in the industry at the moment, execution is. We have much to gain from the tools (or the raw material for tools) and services that we have already purchased. If you’re bored with these problems, you’re in the wrong business.

By failing to get your clinical IT applications and services to work up to their potential, or by skipping the hard work and only strategizing about the future, you’re out at first base either way. In baseball and in business, it’s execution that wins the game, and it’s hard work regardless. To paraphrase Tom Hanks’ character in League of Their Own, “there’s no skpping in baseball.”

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