Experts Tout Electronic Compliance Monitoring to Improve Trials

Electronic compliance monitoring (ECM) enables drug and device firms contemplating clinical trials to more accurately monitor, record and analyze dosing compliance in patients and reduce trial recruitment costs by 25 percent, experts say.

ECM can "provide pharmaceutical companies with information to improve real-world compliance [and] clinicians with better data at the conclusion of the study," John Urquhart, chief scientist at Aardex, said at a June 14 webinar sponsored by MeadWestvaco Healthcare Packaging.

ECM can help make trials more efficient and effective in part by better measuring pill removal from a package or container during a trial, and providing an electronic time and date stamp, Urquhart said. Many trials stumble because patients filling out paper diaries do so in haste toward the deadline or even waiting in the office before turning them in, experts said at the webinar.

Electronic monitoring methods introduced in the late 1980s found that pre-electronic methods of patient monitoring in clinical trials led to "grossly exaggerated" estimates of compliance, Urquhart noted. Those exaggerations include faulty data in diaries, patient histories, pill counts and other checks of untaken medicine. In addition, pre-electronic methods allow the patient the ability to censor the data, he added.

Effect of Faulty Data

Relying on flawed patient data during a clinical trial has "serious implications," said former FDA official Carl Peck, now director for the Center of Drug Development Sciences at the University of California at San Francisco.

These trial pitfalls often occur in Phase II, he said. That often means setting the dosage too high or too frequently, or otherwise not knowing how often a trial participant is actually using the medication, he said.

Inadequate knowledge of the drug's accurate patient data can mean not recognizing adverse events triggered by failure to take the medication, and not being able to model and reliably simulate Phase III confirmatory trials, Peck stressed.

Leveraged properly, ECM can significantly improve the power of the clinical trial through better quality data, said Joyce Cramer, associate research scientist at the department of Psychiatry at Yale's School of Medicine. Cramer has also been active with the International Society for Pharmacoeconomics and Outcomes Research, which has spearheaded efforts to propose standardized definitions and guidelines for retrospective and prospective analyses of compliance.

More Accurate Picture

ECM allows trial conductors to better understand the true minimum effective dose and to get a better handle on the true frequency and severity of adverse events, Cramer said. ECM allows those running the trial to "reliably quantify how the drug will function in its intended use."

It can also provide cost savings. For example, looking at a 12-week Phase II study, Cramer estimated savings of $160,000 with ECM. Under her scenario, that lowers the cost of the study to $1.68 million from $1.84 million. Most of the ECM-related savings come from more efficient patient selection and edata entry with ECM versus no electronic monitoring.

Other ECM return on investments and cost benefits, according to Cramer, include:

Costs are in line with other procedures and measurements of patient data taken during site visits, such as vitals and EKGs; No additional stability testing is required, so it fits into the existing supply chain where blister and bottle packaging are used; Saves time and money by quickly explaining data discrepancies related to noncompliance and reduces analysis time; and Reduces patient population requirements. With an estimated $1,000 to $5,000 spent per patient in a clinical trial, those savings can add up quickly, she said.

ECM will "accelerate the clinical trial process," Cramer said. "And the time has come for reliable data in clinical trials." -- Michael Causey