THE ELECTRONIC AGE- INTEGRATING EPRO/ECOA TO REDUCE PATIENT, SITE, AND STUDY TEAM BURDEN

Author(s)

Holzbaur E, Ross J, Wade M, Rothrock T
Almac Clinical Technologies, Souderton, PA, USA

While some have fully embraced and incorporated ePROs/eCOAs into protocol designs, many continue to use paper PROs/COAs.  This conceptual paper explores reasons for paper PRO/COA continued use, focusing on how PROs can be integrated into the electronic trial solution to reduce the burden to patients/participants, sites, and clinical teams in setting up, maintaining, and closing out a clinical trial. Associated risks and mitigation strategies will be identified in transitioning to ePRO/eCOA collection modes.  Strategies recommended for successful transition to integrated electronic PRO/COA solutions will be discussed. Integration of ePRO/eCOA provides several benefits over paper, including improved compliance and higher data quality.  Comparing the advantages of electronically captured PRO/COA data vs. paper, the benefits of ePRO/eCOA far outweigh those of paper.  Combine this with the support and advocacy of ePRO/eCOA in clinical trials by regulatory authorities and a shift of the general population towards electronic devices; it raises the question why all clinical trials are not using ePRO/eCOA to optimize the integrity of data and trial results.   Common obstacles in the selection of a PRO/COA electronic data collection mode include: paper instruments designed for a paper world, inability to determine true risks, unknown total cost of electronic vs. paper administration, instrument author has sometimes costly requirements for migration, unclear translation expectations, and fear of the unknown.     An assessment of methods to facilitate the transition to electronic data capture will be performed.  Examples include use of items/instruments that are appropriate for electronic platforms and easily migrated and site and patient training plans. In this age of technological advancements, including an integration plan in clinical trials is important to mitigate potential risks and minimize the burden to clinical trial staff and participants.  Detailing this up front can help to alleviate many of the obstacles in the transition from paper to electronic PRO/COA.

Conference/Value in Health Info

2015-05, ISPOR 2015, Philadelphia, PA, USA

Value in Health, Vol. 18, No. 3 (May 2015)

Code

PRM154

Topic

Methodological & Statistical Research

Topic Subcategory

Confounding, Selection Bias Correction, Causal Inference

Disease

Multiple Diseases

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×