Pittsburgh, Penn.-based invivodata, a fully-integrated clinical outcomes assessments company, has been chosen to deliver regulatory consulting services for a phase III trial that UCB is conducting in the development of a unique biopharmaceutical product to treat Rheumatoid Arthritis (RA).
UCB is adhering to recent statements issued by FDA indicating that researchers need to ensure all measurements and outcomes reflect what is actually happening with the patient. Specifically, instruments based upon a clinician’s evaluation of a patient (ClinROs), and measures taken by an observer (ObsROs), like a mother reporting about her child, are subject to the same requirements for reliability and validity as Patient Reported Outcomes (PROs), as delineated in the PRO Guidance.
UCB’s trial protocol includes the Assessment of Joint Tenderness/Pain and Swelling (TSJ/C), a commonly used ClinRO instrument which clinicians use to document tenderness/pain and swelling during physical examination of a patient. UCB is migrating or moving the TSJ/C from the traditional paper-based administration to an electronic tablet, invivodata’s SITEprotablet.
Consistent with FDA recommendations, UCB has contracted with invivodata to demonstrate that the use of an electronic tablet will not affect how clinicians interpret and use the TSJ/C instrument. invivodata’s scientists and regulatory experts will conduct cognitive interviews of clinicians to establish that electronic administration of the TSJ/C is equivalent to traditional, paper-and-pencil administration.
“Since electronic COA data will be the basis of our labeling claims, we needed a partner with not only technological expertise, but one who fully understands the evolving changes in U.S. and European regulations,” said Geoffroy Coteur, senior health outcomes manager, UCB. “We chose to work with invivodata based on their unique, integrated approach to developing, implementing and justifying effective COA strategies.”
Dr. Jean Paty, invivodata co-founder, chief scientist and regulatory officer, said, “To our knowledge, this is the first example of a ClinRO instrument going through a regulatory-driven migration process. We applaud UCB for their pioneering efforts to ensure all of their COA instruments meet the regulatory standard of well-defined and reliable instruments.”