eClinicalHealth Announces New Device-Independent Methodology for Validating ePRO Instruments
eClinicalHealth Limited, a technology and consulting company dedicated to providing innovative clinical trial solutions, has released a methodology to validate and standardize patient questionnaires across different data capture tools.
With scientific support from ICON eCOA practice, eClinicalHealth’s methodology enables clinical trial participants to use their own electronic devices to record patient-reported outcomes while making it easier for researchers to ensure those devices are validated.
Currently, to ensure ePRO tools used in studies meet U.S. FDA guidelines, sponsors often provide patients with dedicated devices — which can be costly, complex to manage and inconvenient. As an alternative, sponsors may ask patients to provide their own devices, requiring the sponsor to validate each instrument used — a task nearly impossible for most studies.
To address this, eClinicalHealth developed a different approach, where a “migration standard” is developed for each instrument. Through collaboration with device makers and patient observation, key elements — such as minimum screen size and placement of instructions — are identified that the standard must address to ensure data captured electronically is of equivalent or better quality than the original paper design. The final, device-independent standard undergoes testing using the industry’s standard testing practices.
With ICON eCOA practice, eClinicalHealth successfully developed a standard for the Anti-Clot Treatment Scale, which was subsequently deployed into clinical studies involving thousands of participants, allowing them to use their own computers, tablets and smartphones.
“We’re pleased how well our methodology has worked in practice,” said Kai Langel, eClinicalHealth’s director of patient solutions. “This is an important step in making clinical research more practical without compromising data quality.”
“Our collaboration with eClinicalHealth proves that new concepts to validate instruments can be developed to support successful bring-your-own-device models,” said Willie Muehlhausen, ICON’s head of innovation.
eClinicalHealth presented a poster about this methodology at the ISPOR annual meeting in May and will present an eCH/ICON-sponsored webinar July 28 at 9 a.m. ET/14:00 UK. For more information, visit www.clinpal.com or www.iconplc.com.
About eClinicalHealth Limited
Headquartered in Scotland, eClinicalHealth Limited, developers of the revolutionary Clinpal patient engagement platform, was founded in early 2012 to provide innovative clinical trial solutions. The company is committed to leading open and collaborative innovation discussions about remote clinical trial processes and technology with pharmaceutical companies, CROs and other service and technology providers.