Generating Relevant Information from Patients in the Technology-Enhanced Era of Patient-Focused Drug Development: Opport
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CURRENT OPINION
Generating Relevant Information from Patients in the Technology‑Enhanced Era of Patient‑Focused Drug Development: Opportunities and Challenges Matthew Reaney1 · Jennifer Cline2 · James C. Wilson3 · Michael Posey2 Accepted: 8 September 2020 © Springer Nature Switzerland AG 2020
Abstract The era of patient-focused drug development (PFDD) brings with it a greater use of patient-reported outcome measures (PROMs) in clinical trials. This is facilitated through electronic technology designed to capture PROM data. However, PFDD goes beyond just PROMs, and technology has a key role in capturing timely and patient-relevant information through active and passive means to inform study endpoints. This brief paper aims to highlight four trends the authors have observed across the pharmaceutical industry in using technology to enhance PFDD: (1) capturing qualitative data from patients; (2) using digital health technology tools (DHTTs); (3) employing reactive technology-enabled clinical outcome assessments TeCOA; and (4) generating passive patient experience data. Opportunities and challenges associated with these trends are discussed, and a ‘call to action’ is made to consolidate learning and understanding across science, medical and technology disciplines, and to conduct collaborative research to improve the opportunities and minimize the challenges.
Key Points for Decision Makers Technology can be better used to enhance patientfocused drug development. We discuss opportunities and challenges for using technology to better capture qualitative and quantitative data. Active, passive and reactive means are considered.
1 Introduction A patient-reported outcome (PRO) is “a measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient’s health * Matthew Reaney [email protected] 1
IQVIA, 3 Forbury Place, 23 Forbury Road, Reading RG1 2JH, UK
2
IQVIA, Pittsburgh, USA
3
IQVIA, Philadelphia, USA
condition without amendment or interpretation of the patient’s response by a clinician or anyone else” [1]. PRO measures (PROMs) are increasingly incorporated into clinical trials to help appraise the impact of disease states and therapeutic treatments known only, at best, by the patient, such as subjective assessments of symptoms of disease (pain, itch), patient functioning, or health-related quality of life [2]. Electronic technology is now routinely used to administer PROMs in drug development trials, conferring significant benefits over traditional paper data collection, such as fewer missing data and more reliable between-visits data capture [3]. This may have facilitated the increase in PROs to support both primary and nonprimary endpoints in clinical trials. As with the development of any endpoint, the PROM must measure a change that is clinically meaningful and should include robust evidence of data to support that claim within a specified patient population. This evidence must include qualitative and quantitative data that fulfil the regu
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