Digital clinical trial: A new norm in clinical research

Abstract

The advent of digital technologies has been well blended with every aspect of human lives. Despite not being a new concept, the adoption of digital health technologies in clinical research, i.e., digital clinical trial has not been utilized extensively. However, with the prevailing COVID-19 pandemics, such transformation in clinical trial seems imminent. Few components of a trial such as consent, remote site monitoring, recruitment process which can be modified through digital technologies, are further specified by the regulatory authorities such as FDA and EMA. However, such novel method cannot be implemented without facing any limitations. All stakeholders pertinent to virtual clinical trial including the provider of digital technologies should align themselves with the patient-centric approach to propagate this concept. It is expected that such a transition is well accomplished and adopted by the sponsors without any compromise in scientific as well as ethical standard.

Exploration of Lived Experiences and Measurement of Burnout Among US Clinical Research Nurses

“…24,25 Clinical research nurses supporting decentralized (remote) clinical trials are highly autonomous and may work separately from the research team as they deliver investigative treatments from home-based or community-based settings. 26 This shift in CRN identity from hospital setting to remote setting requires additional efforts to promote belonging and professional feelings of mattering to the organization. 16 The culture of belonging and mattering not only is a means of reducing stress and burnout among research nurses but may also support retention within hospital and healthcare systems.…”

Effect of a Daily Collagen Peptide Supplement on Digestive Symptoms in Healthy Women: 2-Phase Mixed Methods Study

“…Digital studies offer the advantage of including volunteers in real-life settings when they are able to follow their normal routines, including diet and exercise. Especially during the pandemic, the number of digital studies conducted have increased and can offer significant advantages, in particular with remote site monitoring and recruitment [ 48 ]. Social media can be a good way to attract and recruit study participants by means of word of mouth through family and friends for common issues that are often discussed freely on the web.…”

Clinical research nurse utilisation and role in the conduct of decentralised clinical trials: a literature review

“…Individuals with less financial resource, those who identify in minority racial/ethnic groups, have protocol-excluded chronic diseases but common among their identified community (such as diabetes or non-alcoholic fatty liver disease), and individuals dwelling in rural or frontier geographic locations are commonly overlooked when sponsors select participating research centres (largely urban environments with non-minority, affluent participants). Internationally, almost three out of four persons enrolled in clinical research live two or more hours away from the research site, which impacts the ability to recruit and retain individuals from non-urban communities (Thakur and Lahiry, 2021: 184). In the wake of the COVID-19 pandemic, renewed focus by industry trial sponsors has been placed on decentralised clinical trial (DCT) adoption across global regions to enhance trial recruitment and enrolment.…”

“…Most clinical trials require almost one dozen in-person visits, which is unattainable to most of the population given lost wages, lack of childcare and travel expenses (Thakur and Lahiry, 2021: 184). These barriers have created a slowing down of research enrolment and participation, which amounts to financial losses upwards of 8 million USD per day for trial sponsors (Thakur and Lahiry, 2021: 184). When converting to remote/DCT models from on-site visit models of clinical trial management, the industry immediately saw a 13% reduction in enrolment issues and trial delays, demonstrating the importance of the DCT model for sponsors and participants alike (Thakur and Lahiry, 2021: 184).…”