The migration from paper to electronic is perhaps one of the most significant recent advances for patient-reported outcomes (PROs). However, while many clinical researchers understand the benefits of collecting PRO data electronically, few clinical trial sponsors view the chosen technology systems from the perspective of patients who enroll in clinical trials. Despite the fact that device-based ePRO and interactive voice response (IVR) ePRO are acknowledged as the dominant methods for electronic PRO collection, sponsors sometimes struggle with determining which modality is best suited to capture their PRO data.
Successful use of ePRO today requires an in-depth understanding of scientific and regulatory considerations, coupled with knowledge of the most practical and appropriate technology. Here, two ePRO market leaders - invivodata and Perceptive Informatics – have collaborated to provide the following resources to help sponsors make the best ePRO technology decisions for their clinical trials:
- WHITE PAPER: “PDA or IVR-based Patient-Reported Outcomes Systems: Criteria to be considered when selecting an electronic PRO technology.” This recently published white paper describes an ePRO modality decision tool that provides a systematic, standardized framework for assessing the utility and feasibility of handheld device and IVR systems. The goal of this white paper is to describe the important factors sponsors should consider when selecting an electronic PRO modality. Download the PDA or IVR modality white paper.
- PDA-IVRS ePRO Modality Decision Tool. This newly developed ePRO modality decision tool will guide you in selecting the most appropriate ePRO system based for your clinical trial. It is based on published and unpublished research as well as the substantial experience of invivodata and Perceptive Informatics, and has been further validated by market research with clinical trial sponsors. Complete the PDA-IVR ePRO Modality Decision Tool now.
- WEBINAR REPLAY: "ePRO Industry Best Practice and Regulatory Considerations: An Update on Issues that Affect your Clinical Trials" (original date: March 23, 2010). Two important documents that directly impact the ePRO arena have recently been released: ePRO: Electronic Solutions for Patient Reported and the FDA's final guidance on the use of patient-reported outcomes for labeling claims. In this seminar, scientists from invivodata and Perceptive Informatics will focus on several important ePRO (eDiary and IVR) topics discussed in these documents, including measurement equivalence for ePRO, reducing sample size via ePRO data integrity, migrating clinician instruments to ePRO, and user interface design issues for ePRO. Download the webinar here.