Many terms are used to describe decentralized clinical trials (DCTs) such as ‘virtual’, ‘remote’, ‘site-less’, and ‘hybrid’ but what is the exact definition? The FDA recently defined DCTs as the decentralization of clinical trial operations where technology is used to communicate with study participants and collect data. We outline the different approaches to implementing DCTs.
Decentralized clinical trials (DCTs) are playing a role in an increasing number of drug and biologics development programs. While much has been written about the potential benefits that these trials can bring, our experience in this space has taught us that there are several questions that sponsors should be asking as they consider the end-to-end execution of a DCT.
Raquel Telfer, Senior Clinical Research Associate at Rho, has been in the clinical research industry for over 10 years. She is currently working on a cystic fibrosis study and travels throughout the country monitoring clinical sites to ensure testing and data integrity. Raquel speaks candidly about her experience as a CRA, provides examples of how the clinical landscape is evolving for CRAs and patients, and how she finds energy and inspiration during these unsettling times.
There are a lot of resources on how to deal with slow enrolling studies, but what about challenges with studies that enroll very quickly? Enrollment can be very fast for post-operative acute pain
Completing enrollment is typically one of the most critical milestones in a clinical trial. Enrollment delays impact the study budget, site resources, and downstream timelines. Therefore, it is important to identify potential risks to enrollment early in the study, even during the protocol development process if possible.
Clinical trials conducted during the COVID-19 pandemic have been impacted by public health measures to control the virus. In June, the FDA released a guidance on Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency. We summarized the FDA guidance and some examples of activities Rho has undertaken to maintain trial integrity and patient safety in ongoing and upcoming clinical trials.
The Covid-19 pandemic has presented the industry with many risks and challenges to the management of clinical trials. For many, the mitigation of these issues has accelerated the implementation of decentralized approaches to monitoring and management of clinical trials.
This guide outlines the components you should consider for designing Phase 2 protocols with marketing approval in mind. Phase 2 is a critical make-or-break stage of product development. All too […]
Hybrid, Virtual, and Synthetic clinical trials are becoming a part of an increasing number of drug and biologics development programs. In this webinar, Rho experts discuss how their approach to maximizing the benefits of decentralized trials helps sponsors get the most out of their trials throug
