It’s baseball season and time for baseball metaphors. As we in clinical development go into the technology game these days, we need all of our players on the team. Too often, our lineup is limited to data management and information technology staff. We need clinical staff to “step up to the plate” and help win this essential, serious game.

The better clinical IT applications become (and they are getting better and better), the more they directly impact the daily work of clinical staff, as indeed they are supposed to do. By clinical staff, I mean study managers, CRAs, project managers, medical monitors and advisors, and so on. Much of the clinical IT universe (clinical trials management systems – CTMS; electronic data capture – EDC; adverse event systems (AES); electronic patient-reported outcomes – ePRO; even clinical data warehousing) has been built to be used by and for the benefit of clinical staff. Increasingly in fact, data managers are relatively marginal users. And yet many sponsors still keep clinical staff on the sidelines, or ask them onto the team as an afterthought, when acquiring, specifying, or implementing clinical IT applications. Indeed many of these projects remain the province of sponsors’ fulltime IT staff, who are even further removed from the work of clinical development.

It is by no means always the fault of IT or data management that clinical is an afterthought. At many sponsors, clinical staff want the benefits without joining in the hard work of making IT successful for them. They will whine but they won’t work. Is that too harsh? If you are a clinical professional, how often have you begged off of a clinical IT project team? Were you too busy, understaffed, couldn’t afford to focus on this “peripheral” task? Did it strike you as too “technical”? After all, that’s what the techies are here for – the data managers and the IT folks, right? But no one looks after your interests like yourself; no one knows what you know about your work like yourself; no one can represent the investigators and trial subjects like you can.

Play Your Position

How should clinical staff be contributing to clinical IT projects? The first and most meaningful way is to share in the governance of the project itself. Do not let it be run exclusively by data management or IT. Indeed, it is not inconceivable that clinical could run a project acquiring EDC or a CTMS. Taking governance means that your end-user needs will be met with full attention, rather than taking a backset to the back-end (data management, statistics, executive management). It means that you can help create a timetable which is meaningful to your clinical development plan. And it means that you can significantly alter the prioritization of features and functions.

But with governance participation comes responsibility – not only to show up, on time, but to know how to play this technical game. Participants from clinical should be selected for a proclivity or interest in technical matters. Even with the interest, they will need to learn about technology in some detail – not just about different pieces of software, but about technology platforms (.Net, Java, XML, etc.), basic building block tools (like brand-name reporting tools), and the marketplace (which vendors are being used widely, and why; what are the risks and benefits of innovation, etc.). So what you have is a dynamic learning relationship between clinical and your more technically inclined staff, but both “sides” are fully contributing.

Next comes full participation in the specification of the technology being acquired. And not in the manner in which clinical usually helps out (looking at a sample screen, telling the techies what your favorite report would include). Clinical needs to really draw the vision for how technology is to be used in clinical development, and to understand the potential benefits, risks, costs and burdens. Clinical is usually in a much better position to “think outside the box” on how information technology can help. But this vision must be grounded in some realities of what current and near-term technologies can do. For instance, if your vision of technology in clinical development is grounded entirely in harvesting data from investigator site electronic health records, well let’s just say you’ll have a long wait. But one need not crawl out to the bleeding edge to have a vision. In fact most sponsors do not begin to benefit fully from the technologies they already own. This is where clinical staff need to step up and learn the possibilities, so that even the current investments are properly profitable.

As with the specification phase, clinical staff need to be active participants in vendor research, vendor selection (such as participating in reference checks or usability testing), and in the design and execution of successful software implementation. This latter step is of course quite significant. It means taking a leadership role in process re-design, user acceptance testing (UAT), training, and enterprise communication. Throughout these steps, clinical not only represents the interests of internal staff such as study managers, project managers, medical monitors and pharmacovigilance staff, but also clinical is the best – perhaps only – representative of the needs and perspectives of those not in the home office: the regional monitors, the investigative site and trial subjects themselves.

Throughout, clinical has to commit to this participation. You have to commit a part of your brain, a part of your calendar, a part of your budget. Without a consistency of commitment, from top to bottom in the clinical hierarchy, your contribution will be muted and the enterprise will suffer.

Share the Victory

What’s in it for clinical? Why invest precious time in learning and specifying things which we have technical staff around to do for us? The answer is because the benefits of information technology to clinical development can be so profound, and to date have not been realized, in part because of clinical’s general passivity. If you step up to the plate, by learning how technology can change the way we think about clinical development design, you can share in the victories brought by:

– Compressing the “white space” (the calendar time) between individual trials

– Reducing the number of trials, and altering fundamental trial design, through use of interim analyses

– Meeting the challenge (and exploiting the possibilities) of measuring patient-reported outcomes

– Really knowing, in real time, how a study or a development program is going

– Reducing the workload required to obtain quality safety data and timely reporting

– …and much more.

IT and data management can try and win these games while clinical sits on the bench; the probability and size of your victories will be so much improved if clinical fully joins the team.