Out of Control

Our recent work with pharmaceutical sponsors has revealed a painful reality: too many clinical research departments are not in control of the technology that is their lifeblood. Clinical research today depends on a wide array of computer applications. Clinical data management, trials management, adverse event reporting, electronic data capture, and document management are just the high-level names. Underneath each category, in most companies, is a myriad of mini-applications and separate databases that never talk to each other. This creates that state most humans abhor: not being in control.

The recent Clinical Operations Retreat of The Clinical Research Executive Forum drove home this theme. When technology was discussed by clinical executives from nine pharmaceutical companies, the disconnect between the users of applications, and the design and management of those applications, was universal. What are the implications of this, and what can be done?

What does it mean to be “out of control” of your clinical applications?

The symptoms of this problem are legion. Consider if the following sound familiar to you:

your applications are hard to use

you don’t see the relevance of the application to your daily work, and therefore underutilize or ignore it, crippling its value and timeliness to the enterprise

you were oversold on the benefits of the application, which don’t match reality

you have too many new applications being implemented at once and you are desensitized to the next “top priority”

your priorities differ from those of corporate IT

different versions of your applications migrate forward, and no longer integrate (if they ever did)

your workflow is poorly understood and the application is a mismatch

you’re gathering data you don’t need and nobody uses

the vendors providing the applications can’t support your real-life situations, especially the scale of your worldwide operations

with the use and respect for the applications failing, you don’t have “real” (i.e., “true”) data, and therefore lack the “true” information on which to base decision-making in a timely manner.

How has this situation developed?

The primary cause of applications out of control is the “silo” structure and attitudes common in most companies. Although pharma has responded to this situation in the overall development process by universally moving to the interdepartmental “project team”, this spirit is rarely carried over into operational issues. Thus we see disconnects not only between corporate IT and development, but within development, between data management and clinical, and even within clinical, between monitors and medical staff.

Some of these causes may sound familiar to you:

the corporate IT perspective does not match the business unit need

IT (or data management) considers software applications their exclusive arena

users (including Sites!) aren’t consulted during requirements development, vendor selection, and rollout

clinical groups are too busy to provide input, or to take the time to learn new applications properly

vendors don’t recognize the internal problem at their customer, and don’t contribute to the solution (few understand real-life clinical operations)

users lack the computer expertise which could reduce dependence on other departments and assert requirements and feedback.

In addition, there are challenges to controlling software applications that are not due to interdepartmental gaps:

technology is always changing

resistance to change (on all sides)

executive skepticism (because of a history of failures or lack of financial justification) leading to under-funded implementation, staffing and training

company politics

company policies which are not adapted to the changed process created by the application.

What can be done?

What is out of control must be brought in control. The cases we have heard where some progress has been made on this issue all contain a single element: the clinical department establishes dedicated staff, liaisons, or better yet, a department, who is in control of clinical research IT. This department ideally is separate from data management (where it often lands), so it can represent a superset of interests that encompasses clinical, data management, regulatory and IT. This department’s charter is to empower the clinical development organization to properly and efficiently use technology to speed their work. The staff therefore needs both clinical and software expertise, and the executive must have direct line reporting to, and support from, senior management.

Other initiatives are also critical. Users must be taught how the information they are providing will be used ¡© why it is important to the business, and what they will get out of it. Hardware and network issues should not be forgotten. And vendors should be chosen as much for their understanding of clinical research as for what features their software has.

A clinical IT department is not a cure-all of course. Some of those who have had such departments for years complain of similar problems, because the group has become as out of touch with the user community as an outside department would. So for those who have these departments, renewed emphasis must be placed on bringing users and technologists together, preferably with the user having the final say. Through cognizant, visionary leadership in top clinical positions, these fatal gaps can be bridged. The investment in clinical IT applications is huge and growing. It is such a waste to see them out of control.