ERT granted patents on clinical trial participant compliance
Philadelphia-based ERT, a global technology-driven provider of health outcomes services to sponsors and CROs, has received two additional patents from the U.S. Patent and Trademark Office (U.S. Patent No. 8,065,180 and U.S. Patent No. 8,145,519). The patents are titled System for Clinical Trial Subject Compliance and were acquired by ERT as part of its recent acquisition of invivodata.
"We are very pleased to be issued these additional patents," said Saul Shiffman, Ph.D., pioneer of the electronic patient reported outcomes industry, invivodata founder and one of the inventors of this intellectual property. "It is extremely rewarding to have our processes, which are based on proven scientific principles, be recognized in this manner and to see first-hand the benefits they are delivering to researchers who seek the most reliable and valid patient-centered data possible."
The patents cover the tracking and enhancement of participant compliance with a research protocol and can also be used to provide evaluability data related to participant performance in a clinical trial. Participant compliance is defined as the degree to which trial participants (patients and study teams—including investigative site personnel) meet the expectations of the trial sponsor with regard to using a diary or other reporting mechanism to record answers to questions about their experiences during the trial.
Participant compliance with the protocol is critical to ensuring the success of clinical trials. ERT's electronic diary solutions—DIARYpro for remote patient data collection and SITEpro for site-based data collection—are built on these patented compliance-enhancing methods and have repeatedly proven to capture important COA data at the point of the participant's experience, yielding a more accurate measurement of treatment effect.
ERT has launched a tiered licensing program to enable other industry suppliers to include this functionality in their products. "We will support an open dialogue with other eDiary providers that may want to include participant compliance enhancing features in their solutions," said Dr. Jeffrey Litwin, CEO of ERT. "This constructive dialogue is essential to ensure that the drug-development community has access to the best possible research tools, while protecting our innovative and valuable intellectual property."