ePro

Bill Byrom completed his PhD in disease control simulation at Strathclyde University in 1990 and this work took him to Africa to study the effects and spread of cattle diseases. This interest led him to join the Pharmaceutical industry in 1991 where he began as a clinical trial statistician. Bill transitioned to clinical development where he became a trial director working in a number of early phase therapy areas. Before joining ClinPhone in 2000, Bill took on responsibility for the scientific content of the European market launch of a new antipsychotic agent. Throughout his clinical trials experience Bill maintained an active interest in how new technologies and methodologies could be leveraged in clinical development programmes, and so his move to Perceptive Informatics (formerly ClinPhone) in 2000 was an ideal fit. In his role as Senior Director of Product Strategy he has helped to shape a number of the company's products and services including ePRO solutions, patient recruitment technologies and RTSM (Randomization and Trial Supply Management) solutions. Bill is currently responsible for the company's eClinical strategy. Bill has authored over 60 articles in international and trade journals, and is a regular speaker on the conference circuit. Brian Tiplady, B.A., Ph.D is Senior Clinical Scientist at Pro Consulting, a division of Invivodata Inc. Brian Tiplady started in the pharmaceutical industry in 1976 as a Neuroscientist carrying out clinical research in depression and senile dementia. He later became responsible for data management and statistics, and has worked on every stage of the clinical trial process. He started working with electronic patient reported outcomes (ePRO) in 1993. He has carried out and published evaluation studies on patient use of pen-based handheld diaries and questionnaires, supported in-house projects, and worked with strategic and logistic issues involved in effectively using ePRO, and in evaluating the benefits obtained. He currently works with PRO Consulting, a division of Invivodat Inc, providing scientific support for the development and deployment of ePRO methods in clinical trials.

Introduction; 1: Recall Bias: Understanding and Reducing Bias in PRO Data Collection; 2: Cognitive Interviewing: The use of Cognitive Interviews to Evaluate ePRO Instruments; 3: Data Quality and Power in Clinical Trials: A Comparison of ePRO and Paper in a Randomized Trial; 4: Regulation and Compliance: Scientific and Technical Regulatory Issues Associated with Electronic Capture of Patient-reported Outcome Data; 5: Selection of a Suitable ePRO Solution: Benefit, Cost and Risk; 6: Patient Compliance in an ePRO Environment: Methods for Consistent Compliance Management, Measurement and Reporting; 7: Computerised Clinical Assessments: Derived Complex Clinical Endpoints from Patient Self-report Data; 8: Diary Design Considerations: Interface Issues and Patient Acceptability; 9: Equivalence Testing: Validation and Supporting Evidence When Using Modified PRO Instruments; 10: ePRO Applications and Personal Mobile Phone Use: Compliance Documentation and Patient Support; 11: Future Developments and Applications: Emerging Technologies and New Approaches to Patients