NEW PARADIGMS IN CLINICAL STUDY DESIGN: PATIENT AND SPONSOR PERSPECTIVES FROM A FULLY REMOTE STUDY UTILIZING DIGITAL TECHNOLOGIES

Abstract

TOPIC: Obstructive Lung Diseases TYPE: Original Investigations PURPOSE: Digital technologies offer opportunities to support patients, sites, and sponsors during clinical study preparation/conduct. ENERGITO 2 Digital Health (DH), a Phase IV, fully remote, exploratory study, provided insights related to proactive, sponsor strategic planning and patient participation perspectives that may enhance future clinical research. METHODS: COPD patients aged ≥40 y, smoking history of >10 pack-years, postbronchodilator FEV1 ≥30% to <80% predicted, postbronchodilator FEV1/FVC <70%, internet access, smartphone proficiency, and prior spirometry experience were randomized to a 12-week, double-blind study (tiotropium/olodaterol [T/O] 5/5 μg QD or fluticasone propionate/salmeterol [FP/SAL] 250/50 μg BID). All visits were completed remotely via telemedicine (e-Visit); all procedures—including electronic informed consent, and digital spirometry—were completed entirely remotely using digital technology. To support patient participation, remote/e-Visits could be converted to traditional clinic visits. Investigational medicinal product (IMP) was delivered directly to patients. Lung function and safety were assessed at each e-Visit. Six patient surveys were conducted during the study; patient responses ranged from “very easy to difficult; very satisfied to unsatisfied; very comfortable to uncomfortable.“ A patient focus group was conducted post-study completion. RESULTS: Of 18 patients enrolled, 11 (6 men/5 women; mean±SD age, 66.0±7.27 y) were randomized from 1 US site to T/O (n=6) or FP/SAL (n=5). Sponsor learnings from a protocol simulation were incorporated into the study design to support customer centricity and study conduct in scalability and process. Patient survey responses were generally favorable. Patients reported receiving direct IMP at home was easy and were satisfied with the study drug video training; spirometer training video was very easy to follow—most indicated that performing remote spirometry was easy. Few patients identified technical issues with the invitation process, negative experiences with IMP supplies, occasional spirometer nonfunctioning, and variable audio quality at e‑Visits. The patient focus group provided valuable feedback for future patient-centric, remote clinical trial planning/conduct: offering the flexibility of a combined personal/virtual engagement approach to enhance the patient experience, increased personal connection between clinic visits, and use of supplemental information videos. CONCLUSIONS: ENERGITO 2 DH demonstrated the feasibility of conducting a clinical study remotely in accordance with regulatory guidelines. Technology utilization and proactive and strategic integration of additional operational elements enabled patients to participate remotely as confirmed by patients during and post study completion. CLINICAL IMPLICATIONS: Data support the value of DH solutions in clinical development and use of remote supervised/unsupervised spirometry. DISCLOSURES: No relevant relationships by Sharon Attick, source=Web Response Employee relationship with Boehringer Ingelheim Please note: 1996 to 2021 Added 05/05/2021 by Joanne Franceschina, source=Web Response, value=Salary Principal Investigator relationship with Boehringer-Ingelheim Please note: January 2005 to December 2020 Added 04/30/2021 by Glenn Giessel, source=Web Response, value=Grant/Research Support Employee relationship with Boehringer Ingelheim Please note: 1997-2021 Added 05/05/2021 by Alan Hamilton, source=Web Response, value=Salary No relevant relationships by Patricia Harris, source=Admin input No relevant relationships by John Turner, source=Web Response