Collecting Reliable and Valid Real-Time Patient Experience Data
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35, pp. 755-765. 2001 Printed in the USA. All rights reserved.
Drug Information Journal, Vol.
COLLECTING RELIABLE AND VALID REAL-TIME PATIENT EXPERIENCE DATA MICHAELR. HUFFORD,PHD invivodata, inc., Pittsburgh, Pennsylvania
TERIE. STOKES,PHD GXP International, Concord, Massachusetts
JEAN A.
PATY,
PHD
invivodata, inc., Pittsburgh, Pennsylvania
The collection of real-time, real-world patient experience data that are reliable, valid, and sensitive to drug effects presents many challenges to clinical trial sponsors and investigators. Recent developments in electronic patient experience diary (PED)systems highlight the importance of building a robust, subject-jriendly system that can enhance subjects’ protocol compliance and is regulatory compliant. To succeed in a clinical trial, an electronic PED system must simultaneously meet two related standards: clinical integrity and system integrity. Clinical integrity includes the elements of protocol compliance, measurement reliability, data validity, and auditable subject quality. An electronic PED system with clinical integriry produces compliance metadata that can be used to better understand and evaluate the eficacy data. System integrity includes the elements of management control, system reliability, data integrity, and auditable system quality for computerized data handling. An electronic PED system with system integrity collects data that have been authenticated by built-in logic and security checks and can be attributed to the subject. The challenges and promises of such a system are presented. Key Words: Clinical integrity; System integrity; Validation; Compliance;Electronic diaries
INTRODUCTION
methodological advances make it possible to capture reliable and valid data from subjects THE RELIABLE AND VALID measureregarding their experiences with medication ment of drug effects is a cornerstone of phareffects, symptoms, self-observations, and maceutical research. While the physiological quality of life-which we collectively term measurement of drug effects has evolved patient experience. As will be presented beconsiderably over the past 50 years, the mealow, the collection of reliable and valid patient surement of patients’ subjective experiences experience data requires data collection from of drug effects has not kept pace with the subjects in the real world, in real time. Increas‘harder,’ physiological measures. Recent ingly, electronic methods are being used in an attempt to capture these data. The criteria for the successful capture of patient experience Some of the material in this manuscript was presented data include clinical and regulatory issues. at the DIA’s “6th Annual Computer Validation Meeting: Treating Validation from a Systems Perspective,” September 2000, Washington, District of Columbia. Reprint address: Michael R. Hufford, PhD, invivodata, inc., 2100 Wharton St., Ste. 505, Pittsburgh, PA 15203. E-mail: [email protected].
Patient Experience Measurement Before delineating the criteria for collecting reliable and valid diary data, we
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