eCOA development and evaluation
As electronic data capture becomes commonplace in clinical trial design, regulatory agencies are asking for data to demonstrate the equivalence of eCOAs and their paper counterparts. Generating such evidence prior to trial commencement saves time in addressing regulatory questions later.
Several senior members of our team are well-versed in the issues around development, feasibility and usability testing, migration and evaluation of electronic versions of PRO/COA instruments. Services we provide in this space include:
We conduct all levels of usability, feasibility and equivalence testing to provide evidence for the validity of electronic and paper measures in a wide range of respondents. This includes challenging populations such as pediatrics and geriatrics. The extent of modification required to migrate an instrument to electronic format and the context of use informs the level of testing required.
Therapeutic areas where we have conducted equivalence, usability and feasibility studies include: chronic pain, oncology, psychiatric conditions, gastrointestinal disorders, respiratory diseases and women’s health.
In addition to the above capabilities, increasingly newly developed de novo PRO/COA instrument are developed electronically from the beginning. Developing a COA instrument in that context provides specific advantages, challenges and considerations which should be taken into account. The experience of the Adelphi Values team in developing and testing eCOAs means we are extremely well placed to work with clients to develop instruments electronically. We firmly believe that electronic administration is the future of COAs, and developing instruments to take advantage of the benefits of electronic delivery is critical.
S. Tatlock, L. Abraham, A. Bushmakin, M. Moffatt, N. Williamson, C. Coon & R. Arbuckle. Psychometric evaluation of electronic diaries assessing side-effects of hormone therapy. Climacteric 2018; 29:1-7
Delgado-Herrera L, Banderas B, Ojo O, Kothari R, Zeiher B. Diarrhea-predominant irritable bowel syndrome: creation of an electronic version of a patient reported outcome instrument by conversion from a pen-and-paper version and evaluation of their equivalence. Patient Relat Outcome Meas. 2017; 8:83-95.
Norquist J, Chirovsky D, Munshi T, Tolley C, Panter C, Gater A. Assessing the Comparability of Paper and Electronic Versions of the EORTC QOL Module for Head and Neck Cancer: A Qualitative Study. JMIR Cancer. 2017 May 12;3(1):e7
Tolley C, Rofail D, Gater A, Lalonde JK. The feasibility of using electronic clinical outcome assessments in people with schizophrenia and their informal caregivers. Patient Relat Outcome Meas. 2015; 6:91—101