Decentralized Clinical Trials
Rapid evolution: How DCT’s DNA became standard in modern clinical trials
It’s impossible to deny how different clinical trials look almost four years after the pandemic revolutionized clinical research. Today, the digital and decentralized tools and technologies that enabled clinical trials to carry on through the COVID-19 pandemic are present (in some form) in nearly all clinical trials, a far cry from the dynamics of 2019.
The Digital Future is Now eBook
According to Grandview Research,the hybrid and decentralized clinicaltrial (DCT) market will be worth more than 12 billion dollars by 2030. Sparked by the COVID-19 pandemic of 2020, the rapid ascent of patient centered technology and the digital and decentralized trials they’ve spawned has forever changed the landscape of clinical conduct.
The Definitive Guide to Digital Evidence Generation
According to Grandview Research, the hybrid and decentralized clinical trial (DCT) market will be worth more than 12 billion dollars by 2030. Sparked by the COVID-19 pandemic of 2020, the rapid ascent of patient-centered technology and the digital and decentralized trials they’ve spawned has forever changed the landscape of clinical conduct. Sponsors are increasingly turning to DCT platforms in alignment with the rise of Life Science and Software-as-a-Service (SaaS) solutions. For those who haven't made the jump yet, there are many questions, including "What is a decentralized clinical trial?" Find out with this in-depth guide to decentralized clinical trials. Uncover how they work, their benefits, and how they transform clinical development.
Back to Basics: What is a decentralized clinical trial?
In a decentralized clinical trial, part or all of the protocol occurs away from the primary study site. Instead of patients traveling, often repeatedly, to a central site for enrollment, consent, data collection or symptom monitoring, they can participate in telehealth visits from their homes, often using familiar technologies, like smartphones, tablets and wearables to transmit pertinent information. Even medications and devices can increasingly be delivered directly to a patient’s home, and a home visit from a health care professional can be arranged if necessary.
Back to Basics: What is clinical trial recruitment?
Patient recruitment is one of the most critical elements of a clinical trial. Without sufficient participation, studies will lack the power to demonstrate the statistical significance and efficacy of new treatments. Ultimately, poor patient enrollment will delay or prevent new therapies from reaching the market. Not only do such delays cost millions of dollars, but they also deprive patients of effective, potentially life-changing treatments.
Back to basics: What is patient screening?
Patient screening, a vital step in the clinical trial recruitment process, is when interested participants are assessed for their eligibility for a given trial using select inclusion/exclusion criteria. These criteria help characterize the target patient profile to ensure patient safety, better efficacy, and optimized signal detection.
Traditionally, patient screening was done in person at a clinical trial site. Due to the current digital revolution in healthcare, which has recently accelerated in response to global health events, the ability to use cloud-based software and digital qualification steps to optimize patient screening and enrollment brings innovation, convenience, and sophistication to this process.
Back to basics: What is electronic informed consent (eConsent)
While informed consent form (ICF) signatures traditionally have been collected on paper at a physical site, today’s digital approach — electronic consent (eConsent) — offers more than high-tech signature collection. It provides an upgrade to patient education and communication as well, empowering participants in new ways. Moreover, eConsent can democratize clinical trial access, allowing researchers to recruit broader and more diverse participant groups through entirely remote consenting processes. This broader and less burdensome access also can increase the speed of recruitment and reduce drop-out rates.
Back to basics: How digital and decentralized clinical trials enable trial diversity
The advancement of decentralized clinical trials (DCTs) allows patients to participate without having to travel to a trial site, removing many barriers that may have hindered people of diverse backgrounds from participating.
How we standardized deploying vaccine studies in five weeks
By Musaddiq Khan, VP, DCT Solutions
At Medable, we’re always looking to understand the changing environment of clinical research, and how we can help customers overcome the various challenges, risks, and scenarios that these changes bring.
For the past year, I, various clinicians, and research experts at Medable have been working closely to improve how we conduct research for various therapeutic areas. Much like the results shown in Tufts CSDD’s latest whitepaper, we believe that a well-thought, decentralized approach can help bring new therapies in historically challenging therapeutic areas to markets faster.
The result of this work is a brand-new decentralized approach we’re bringing to the market.
Report: Medable named #1 Leader in DCT for second year by Everest Group
For the second consecutive year, Medable has been named Leader decentralized clinical trial products per the Everest Group’s PEAK Matrix® assessment, which evaluates DCT products from 24 companies based on vision, capability and market impact.