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Collecting Reliable and Valid Real-Time Patient Experience Data

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Abstract

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-friendly 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 integrity produces compliance metadata that can be used to better understand and evaluate the efficacy 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.

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Author information

Authors and Affiliations

  1. invivodata, inc., 2100 Wharton St., Ste. 505, Pittsburgh, Pennsylvania, 15203, USA

    Michael R. Hufford PhD

  2. GXP International, Concord, Massachusetts, USA

    Teri E. Stokes PhD

  3. Invivodata, inc., Pittsburgh, Pennsylvania, USA

    Jean A. Paty PhD

Authors
  1. Michael R. Hufford PhD
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  2. Teri E. Stokes PhD
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  3. Jean A. Paty PhD
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Corresponding author

Correspondence to Michael R. Hufford PhD.

Additional information

Some of the material in this manuscript was presented at the DIA’s “6th Annual Computer Validation Meeting: Treating Validation from a Systems Perspective,” September 2000, Washington, District of Columbia.

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Hufford, M.R., Stokes, T.E. & Paty, J.A. Collecting Reliable and Valid Real-Time Patient Experience Data. Ther Innov Regul Sci 35, 755–765 (2001). https://doi.org/10.1177/009286150103500314

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