Patient experience in clinical trials: results of a survey

Lucas, Rebecca; Wang, Shu Fang; Riley, Jillian; Pepper, John; Cowie, Martin R.

doi:10.1002/ejhf.1105

Cited by 2 publications

(1 citation statement)

References 4 publications

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“…While several articles describe how the trial process is changing and the benefit of patient involvement in the design of clinical trials [ 1 – 4 , 6 – 12 ], little evidence describes the actual experiences of patients in clinical trials [ 13 , 14 ] and none describe the experience of patients in clinical trials with H/RMT. Instead, there is abundant literature on home-based rehabilitation, as well as home-based monitoring of symptoms and delivery of medicines [ 15 – 18 ].…”

Section: Introductionmentioning

confidence: 99%

Patient and Healthcare Professional Insights of Home- and Remote-Based Clinical Assessment: A Qualitative Study from Spain and Brazil to Determine Implications for Clinical Trials and Current Practice

Lalanza¹,

Peña²,

Bezos³

et al. 2023

Adv Ther

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Introduction The SARS-CoV-2 virus pandemic has accelerated the growing trend towards using home- and remote-based medical testing (H/RMT). The aim of this study was to gather insights and explore the opinions of patients and healthcare professionals (HCPs) in Spain and Brazil regarding H/RMT and the impact of decentralised clinical trials. Methods This qualitative study consisted of in-depth open question interviews of HCPs and patients/caregivers followed by a workshop that aimed to determine the advantages and barriers to H/RMT in general, and in the context of clinical trials. Results There were 47 participants in the interviews (37 patients, 2 caregivers, 8 HCPs) and 32 in the validation workshops (13 patients, 7 caregivers, 12 HCPs). The main advantages for the use of H/RMT in current practice were the comfort and convenience, the ability to improve the relationship between HCPs and patients and personalise patient care, and the increased patient awareness towards their disease. Barriers to H/RMT included accessibility, digitalisation, and the training requirements for both HCPs and patients. Furthermore, according to the Brazilian participants, there is a general distrust in the logistical management of H/RMT. Patients indicated that the convenience of H/RMT did not influence their decision to participate in a clinical trial, with the main reason for participating in a clinical trial being to improve health; however, H/RMT in clinical research does aid adherence to the long-term follow-up associated with trials and provides access to patients living far from the clinical sites. Conclusion Insights from patients and HCPs suggest that the advantages of H/RMT may outweigh the barriers, and that social, cultural and geographical factors and the HCP–patient relationship are critical aspects to be considered. Moreover, the convenience of H/RMT does not appear to be a driver for participating in a clinical trial but can facilitate patient diversity and study adherence. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-023-02441-0.

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Section: Introductionmentioning

confidence: 99%

Patient and Healthcare Professional Insights of Home- and Remote-Based Clinical Assessment: A Qualitative Study from Spain and Brazil to Determine Implications for Clinical Trials and Current Practice

Lalanza¹,

Peña²,

Bezos³

et al. 2023

Adv Ther

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The trialist’s perspective: what do you need to prove for remote monitoring devices to be approved?

Angermann

2019

European Heart Journal Supplements

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Due to contrasting results from clinical trials, remote monitoring devices have so far rarely been approved for heart failure (HF) management in European countries. Implementation of telemedicine into clinical practice of heart failure outpatient care is still limited. As part of an expert meeting on physiological monitoring in the complex mutimorbid HF patient, the needs to establish evidence supporting the use of devices in heart failure outpatient care was discussed according to a trialist’s perspective. This document reflects the key points debated by a multidisciplinary panel of leading international experts on this topic.

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Patient experience in clinical trials: results of a survey

Cited by 2 publications

References 4 publications

Patient and Healthcare Professional Insights of Home- and Remote-Based Clinical Assessment: A Qualitative Study from Spain and Brazil to Determine Implications for Clinical Trials and Current Practice

Patient and Healthcare Professional Insights of Home- and Remote-Based Clinical Assessment: A Qualitative Study from Spain and Brazil to Determine Implications for Clinical Trials and Current Practice

The trialist’s perspective: what do you need to prove for remote monitoring devices to be approved?

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