Pegus Research selected DSG’s eCaseLink EDC software to conduct a Population Safety Trial (PST) to evaluate the safety of a prescription drug. The trial is being conducted for an unidentified top 10 pharma. Clients at the Utah-based Pegus, a pharmacoepidemiologic contract research organization (CRO), include some of the largest sponsors in the industry as well as state governments and insurers. 

According to the news release, the study will include 1,000 subjects at 36 pharmacies throughout the country. It went live in August, 2006 and will continue through January 2007. The trial is entirely paperless or, in the jargon, eSource. Data are entered directly into the computer; no hard copy source documents are created. It is the second trial in which DSG and Pegus Research have partnered.

The PST, also known as an Actual Use Trial, is being conducted to provide data to support a prescription to over-the-counter (OTC) switch. The PST will measure the effectiveness of the labeling directions for appropriate dosing and duration of use, as well as warning statements. The method has proven efficient in collecting information about usage patterns and adverse events for drugs as they enter the prescription market or make the transition to the non-prescription market.

“The PST is a new switch strategy we developed to assess the safety of a drug in the population of actual users who use the study drug the way they normally would. Our expertise in designing and implementing actual use research to support OTC switch applications led to the development of this new method, which has been used by many leading health and consumer product campaigns globally,” said David McCammon, president of Pegus Research. Clinical interviewers follow up with participants by telephone to gather data about how the drug was used.

Pegus Research has successfully managed care studies and population risk trials for a variety of pharmaceutical companies, consumer product safety companies, and managed care companies. Pegus’ PST method has been used by many leading health and consumer product campaigns in the US and internationally. The company manages scientific research from study design and project development through data collection and analysis to final reporting.

“A PST can produce the safety data required by regulatory agencies in less time than required by other methods, and using eCaseLink saves an even greater amount of time because there are no hard copy source documents. Everything is electronic,” said Tony Varano, CEO of DSG.

Is it unusual to go paperless in such a study? “In a switch [study], it is relatively common,” Varano says. “These are really interesting trials. They are all e-source. We’re doing another one. They’re going from prescription drug to OTC. People come in off the street and they’re interviewed by the pharmacist or investigators and coordinators who enter the data directly into the system. There is no paper backup, no paper in the process at all.”

Varano says that the contracts in the post-marketing phase do not necessarily translate into more business with CROs in Phase II and III. “Because of the dynamics of Phase III, it may not lend itself to an e-source opportunity,” Varano says.