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.
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.
On-site facility evaluations have historically provided us with the insight necessary to determine site performance and viability for our clinical trials. With decentralized trials as a mainstay of the current clinical research landscape, it’s imperative to leverage the virtual resources available to cultivate those same meaningful evaluations and assessments, safeguarding patient safety and data integrity.
As research teams develop more cellular and gene therapy products for the treatment of a wide array of medical conditions, the need for custom nonclinical and clinical programs required to support market approval of products that are based on human cells, tissues, or HCT/P will rise. And for RMAT designated products, the study designs may be substantially different from more traditional IND programs.
Productive pre-IND interactions with FDA are important to the success of any drug development program, including infectious disease product development. The Pre-IND Consultation Program through the Office of Infectious Disease (OID), one of 27 review divisions within the Office of New Drugs, provides opportunities for makers of infectious disease products to engage with FDA by facilitating early communications between the Division of Antivirals or the Division of Anti-Infectives within OID and sponsors/investigators of potential new therapeutics – these products include drugs and therapeutic biologics for the treatment of bacterial, fungal, and viral infections (including SARS-CoV-2 infection).
The COVID-19 pandemic has accelerated the implementation of decentralized (also referred to as virtual, remote, or hybrid) solutions for clinical trials. In addition to keeping your clinical trials on-track during the pandemic, decentralized solutions can often provide added benefits, including an improved patient experience by increasing engagement and reducing patient burden. We will discuss some considerations for successfully implementing decentralized solutions.
The FDA continues to release additional information and update their website as the COVID-19 pandemic continues and both regulatory professionals and drug developers react to the potential for novel and repurposed products to treat COVID-19. This blog post is the latest installment in a series of COVID-19 related blog posts and updates information provided in a recent webinar.
With the industry-wide push towards patient-centricity, electronic clinical outcome assessments (eCOAs) have become a more widely used strategy to streamline patient data collection, provide real-time access to data for review and monitoring, enhance patient engagement, and improve the integrity and accuracy of clinical studies. Rho answers some commonly asked questions about eCOAs.
Four scientific principles. One unifying concept. The Cohesion Effect experience. SCOPE Summit is a place where innovation thrives. Thousands of attendees and hundreds of exhibitors from around the world, all
When Tonix came to us, the stakes were high, and the timelines were tight. Their goal? To submit a New Drug Application (NDA) for TONMYA™ and, for the first time
Every CRO out there will tell you they’re site-centric, and on pitch decks, they use the right buzzwords to prove it. Curious. Collaborative. Dependable. Problem-solvers. Sound familiar? That’s great in
You’re responsible for showing risk oversight, protocol clarity, and a site-friendly design—but you’ve got a lean team, a looming trial, and no time to decode the 110-page ICH E6(R3) guidance.
ICH E6(R3) is here, and with it, clinical teams are bracing for the impacts. Biotechs are being asked to develop clear and concise protocols, demonstrate oversight throughout the trial, integrate
On 26 April 2023, the European Commission (EC) proposed reforming the European Union (EU) pharmaceutical legislation. This revision constitutes the first major overhaul of the pharmaceutical legislation since 2004. It will adapt the legislation to the needs of the 21st century.
For the first time, some children with life-threatening food allergies can safely eat in the school cafeteria and celebrate at a friend’s birthday party without fear of accidental allergen exposure. That’s not just progress—it’s the kind of outcome that reshapes lives and changes what’s possible in clinical development.
Sponsors are generally aware of the commonly held Type B FDA meetings, from pre-IND to End of Phase 2 (EOP2) to pre-NDA/BLA, but how often do you take advantage of additional Type C meetings for agency feedback? Continued discussion and input from the agency can be very beneficial, even outside of the milestones that allow for a Type B Meeting.
According to the Study Data Technical Conformance Guide (October 2024), sponsors should prepare a document called the study data standardization plan (SDSP) for each of their development programs to describe the submission of standardized non-clinical and clinical study data to the FDA.
Most of those who work with Clinical Data Interchange Standards Consortium (CDISC) datasets have probably heard of the term “traceability.” But why is it important and how can it best be implemented?
