Getting real with trials

RALEIGH, N.C.—You don't send a pilot out to fly and land his or her first plane with only book knowledge. According to INC Research and TheraSim, you shouldn't send researchers into a clinical trial without some hands-on experience with the issues they will face in that trial, either.

To help make sure clinical researchers do go into trials better prepared for success, therapeutically focused contract research organization INC Research has partnered with TheraSim, which has a strong position in clinical performance management (CPM) technology. Together, they are putting together a CPM system that will provide an interactive patient simulation environment designed to both assess and improve the skills and behaviors of clinicians.

CPM itself is a relatively new field and the technology is aimed mostly at clinicians in patient care settings rather than clinical trials. But executives at both companies believe there is a pressing need to bring CPM to trial sites.

"We've had great success with CPM on the clinical side and it was always our intention to move into the trials management space," says David Hadden, CEO of TheraSim. "We're pioneering that effort with INC. The training of doctors hasn't changed much from the time of Hippocrates. So much of it is still about reading and listening to lectures. We're trying to train clinicians the same way we train pilots. If you give a newly schooled pilot a flight manual and a month to study it, he will still crash the plane. But if he spends a couple days in a simulator, he can probably fly and land it."

The system under development is designed to rapidly assess site competence; correct deficiencies in Good Clinical Practice and Good Laboratory Practice and protocol adherence through targeted training; and help clinicians develop new skills to continuously improve their competency at a site level. INC Research initially plans on implementing the TheraSim CPM system for investigator site training, which the company says is critical to the clinical trial process—particularly with the current lack of a global standards for training and development.

As Hadden notes, there are perhaps a dozen correct things clinicians can do to patients in a clinical trial, but there are thousands of ways to make mistakes. Using CPM system, he says, should help those clinicians make all the possible mistakes before they touch an actual study participant.

In addition, the system not only provides training but also collects data that can help predict and head off errors before they occur in a trial, notes Jean Chitwood, vice president of corporate administration at INC Research.

"It also helps with turnover," she adds, "because people who are originally trained in a study's protocol may leave and other people come on, so it gives us a platform on which to code the methodology so that we can make sure new staff are brought up to speed most efficiently."

"Our software does not create the methodology and protocols but it does a great job of ensuring that the behavior of clinical trial investigators and study coordinators conforms to the process," Hadden says. "TheraSim CPM measures and reduces the variability introduced by the human element in the process."

This can also help build confidence in global sites in which a company may need to operate clinical trials, Chitwood says. With the need to conduct trials outside the United States increasing, this is a particular concern for U.S.-based companies that want to ensure consistent, repeatable standards worldwide and minimal trial variability.