OBJECTIVES: Several new research reports coupled with statements by regulatory authorities indicate that the penetration, models for use, and acceptance of patient reported outcomes (PRO) collected electronically (ePRO) is rapidly evolving for clinical drug trials. METHODS: In one recent study, the Patient Global Impression of Improvement was modified to include a verbal recording of the subject's health status at the beginning of treatment. This recording was then subsequently used to orient the subject at every subsequent rating and resulted in a 16% difference in effect size (0.0526 vs. 0.612) when compared to the standard PGI-I. For compounds with a fast onset-of-action profile, it is critical that data be collected outside of the office setting. In a separate study (n=137), patients started at higher doses of the study drug (duloxetine) reported greater improvement by day one in shoulder and back pain when compared to a lower dose of the same drug. Patients also reported statistically significant (p<0.05) reduced pain while awake by day three, improved overall pain by day two, global emotional improvement by day three, and global physical improvement by day seven. This improvement data was collected electronically using a verbally administered numeric scale. RESULTS: In both cases, these data would have been difficult, if not impossible, to collect reliably at the study site or via paper. Sponsor acceptance of ePRO data is shown by a recent survey of 156 webinar registrants that found that 36% indicated that they have included, or intend to include, ePRO data in a regulatory submission as a primary (22%) or secondary (14%) endpoint. CONCLUSIONS: This session reviews the methods and associated research for verbally orienting a study subject and verbally administering analog scales in clinical trials. Additionially, regulatory acceptance of electronic patient reported outcomes in clinical trials is explored through real world case studies.