US FDA Guidance on Decentralized Clinical Trials
Decentralized, virtual, siteless, remote-all buzzwords in the clinical trial arena that are gaining increased traction in the post-pandemic landscape. Although started during the COVID-19 pandemic as a means of patient convenience and allowing for the progress of trials irrespective of safety and travel restrictions and social distancing rules, decentralized trials seem here to stay. As […]
Remote Patient Recruitment in Clinical Trials: Methods, Advantages, and Challenges
Remote Patient Recruitment Methods in Clinical Trials, Discover the advantages and challenges of recruiting patients remotely. Patient recruitment and retention are one of the biggest challenges in trial progression along with other reasons such as inadequacy in documentation practices and suboptimal knowledge about regulatory guidance. Studies have shown that patient recruitment is the single […]
Patient-Centric Clinical Trials: Use of eConsent, ePRO, and eCOA
The steady and progressive shift of the clinical trial landscape to incorporate the Patient Centric Clinical Trials is a culmination of several factors such as digitization, artificial intelligence, increased patient awareness, access to mobile devices, and the more recent COVID-19 global pandemic. Unlike the traditional clinical trial paradigm that is centered around sites and sponsors, […]
Hybrid Clinical Trials: Introduction and Current Trends
Digital technology and the COVID-19 pandemic have catapulted the rise of virtual, decentralized, or Hybrid Clinical Trials. Unlike traditional trials in which almost all the trial activities such as patient recruitment, consent, and site visits involve face-to-face contact between the participant and healthcare provider or clinical trial site staff, virtual or decentralized trials make use […]
Hybrid Clinical Trials Design: Strategy and Virtual Tools
When we think of hybrid clinical trials Design, we usually picture traditional randomized controlled trials (RCTs) where participants are allocated to one of two treatment groups (standard or experimental) under the close watch of clinicians and healthcare professionals. Participants are monitored frequently for vital signs and adverse events in an in-clinic setting or central site […]