UCB has called on the Clinical Outcome Assessment (COA) expertise of invivodata to help it migrate from paper-based to electronic administration of a commonly used ClinRO (clinician-reported outcomes) instrument in evaluating a new product for rheumatoid arthritis (RA).
The US-based specialist, which supplies device-based eDiaries and other data-collection tools to the biopharmaceutical and medical device industries for use in clinical trials, will deliver regulatory consulting services for a Phase III study UCB is conducting with a unidentified novel biopharmaceutical in RA patients.
UCB’s trial protocol includes assessing joint tenderness/pain and swelling with TSJC (total swollen joint count), a ClinRO instrument routinely used by clinicians during physical examinations of patients.
Shift to SitePRO
UCB is shifting its TSJC administration from the traditional paper-based approach to an electronic tablet – invivodata’s SITEpro, a patient-data collection system that can capture ClinROs, PROs (patient-reported outcomes) or ObsROs (observer-reported outcomes) at investigative sites.
In line with recent recommendations from the US Food and Drug Administration (FDA), UCB has contracted with invivodata to demonstrate that use of an electronic tablet will not affect how clinicians interpret and use the TSJ/C instrument.
Scientists and regulatory experts from invivodata will conduct cognitive interviews with clinicians to establish that electronic administration of the TSJ/C is equivalent to traditional paper-and-pencil administration.
Changing regulations
“Since electronic COA data will be the basis of our labelling claims, we needed a partner with not only technological expertise, but one who fully understands the evolving changes in US and European regulations,” commented Geoffroy Coteur, senior health outcomes manager at UCB.
“We chose to work with invivodata based on their unique, integrated approach to developing, implementing, and justifying effective COA strategies,” he explained.
The FDA has indicated that researchers need to ensure all measurements and outcomes in clinical trials reflect “what is actually happening with the patient”, invivodata noted.
Specifically, ClinROs and ObsROs are subject to the same requirements for reliability and validity as Patient Reported Outcomes.
