ePRO Resources
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Carl Pelzel
Executive Vice President and COO, Depomed, Inc.
ePRO Resource Center > ePRO Benefits in Select Therapeutic Areas
ePRO Benefits in Select Therapeutic Areas
Clinical studies in nearly all therapeutic areas have benefited from electronically captured real-time Patient Reported Outcomes (PRO) data. Many sponsors have published the results they have seen when capturing ePRO data and how this real-time data helped them to evaluate the efficacy of their treatments in development.
Click here to access related articles and additional information about the benefits of ePRO in various therapeutic areas:
- Read “Fibromyalgia Trials Successfully Measure Subjects’ Pain”; Gendreau, M., Gendreau, J., Navis, B.D., Gwaltney, C., Paty, J., BioExecutive International, 2007
Summary: Cypress Bioscience established the clinical and regulatory framework for evaluating compounds targeted at Fibromyalgia Syndrome. This article reviews how the development and implementation of real-time methods for tracking patients’ pain using electronic diaries was key to this evaluation. - Read “Proving the eDiary Dividend”; McKenzie, S., Paty, J., Grogan, D., Rosano, M., Curry, L., Sciarappa, Hufford, M., Applied Clinical Trials, 2004 (overview of eDiary Application in Overactive Bladder trial)
Summary: This article reviews the tangible value Sepracor Pharmaceuticals realized by capturing real-time PRO data with invivodata's eDiary system in a Phase III clinical trial. The authors demonstrate how increasing patient compliance reduced error variance, which increased the trial's sensitivity and provided a more reliable measurement of the drug's effectiveness. - Read “Assessment of post-surgical recovery after discharge using a pen computer diary”; Begg, A., Drummond, G., Tiplady, B., Anaesthesia, 2003
Summary: Patients were assessed after their return home from gynaecological surgery using a daily pen-based electronic diary. They also completed a questionnaire at the end of the study month. The article concludes that daily electronic pen-diaries are an acceptable method of obtaining better information on the extent and duration of symptoms and other difficulties after discharge following surgery. - Read “Correspondence Between Paper and Electronic Visual Analog Scales in Adult Asthmatics”; Hufford, M., Shiffman, S., White Paper, 2001
Summary: The Visual Analog Scale (VAS) is a widely used assessment format that allows patients to rate a variety of subjective symptoms on a continuous scale. This validation study sought to examine the correspondence between paper and electronic versions of the same 3-item VASs, and confirmed that subjects rate their experience similarly regardless of whether the assessments are represented on paper or on a handheld electronic diary.