Clinical trial sponsors are constantly seeking ways to collect better data, faster—accelerating clinical trials. Meanwhile, patients are increasingly likely to access healthcare services and interact with healthcare professionals digitally. Growing usage of telehealth also impacts patients’ expectations of clinical trials, with convenience and accessibility taking center stage.
Now, sponsors across the life sciences industry are finding ways to achieve all these goals: better data, more engaged patients, and faster clinical trials. Decentralized clinical trials (DCTs) reduce inefficiencies and delays at every stage—improving the experience for patients and study management teams alike.
In fact, recent analysis from Clinical Trials Arena projects clinical trials with a decentralized and/or virtual component will increase 28% in 2022 versus 2021.
Learn about integrating DCT elements throughout the trial journey.
Decentralized components can support and accelerate every stage of a trial, significantly decreasing the time to completion without compromising safety or quality.
Let’s explore each step to understand how decentralization drives efficiency throughout the clinical trial process.
Learn more about decentralized clinical trial solutions by booking a demo today.
Not every trial is a fit for full decentralization, and many sponsors prefer an incremental model to digital transformation. Configurable DCT platforms allow study teams to tailor the study protocol and methods for each new trial without starting from square one each time.
Rather than deploying a fully virtual clinical trial, design teams can configure the elements that are the best fit for a particular trial. A modular approach that blends DCT and site-based methods can accelerate clinical trials from beginning to end while still maintaining critical site components.
For example, a pharmaceutical company seeking to run an interventional trial for a new drug can:
Similarly, a digital health device study team may:
In both examples, modular study design enables the selection of trial components that are best adapted to that particular protocol, often without the need for customization, thus condensing the time needed for study start-up.
The recruitment and enrollment phase of DCT and hybrid trials is frequently two- to four-times faster than that of traditional site-based trials. Tools such as social media targeting have all but eliminated geographical boundaries in the recruitment process. Online recruitment allows sponsors to tap into larger patient pools and, in return, accelerates enrollment.
After prospective participants respond to targeted ads, they can often proceed through the entire enrollment process on their mobile devices by:
Leveraging digital recruitment and enrollment is a proven path to accelerating clinical trials. A recent study of Renovia’s leva® Pelvic Health System adopted a DCT approach to recruitment and onboarding, including social media targeting. These techniques facilitated the recruitment of 350 fully qualified participants in just 14 weeks.
Data loss caused by participant dropout or low compliance rates can diminish a study’s power—slowing or inhibiting the clinical trial process for sponsors. In a DCT or hybrid study, user-friendly reporting tools directly support compliance and adherence.
Digital solutions like electronic patient reported outcomes (ePRO) streamline patient reporting of symptoms, side effects, vital signs, and other required health data. With ePRO, study teams can reduce the risk of respondents dropping out of a study due to excessive time or travel burdens.
When a clinician’s assessment is necessary, patients can sometimes record their symptoms through image, audio, or video so that expert raters can review without the need to schedule an appointment with a clinician. Raters can then use expert clinical outcome assessment (eCOA) tools to further streamline the process. For instance, augmented ePRO platforms leverage machine learning and artificial intelligence to facilitate expert reviews with less variability.
With a DCT platform, the data is all in one place, giving the study team clear visibility in real time throughout the trial. Study teams can see, check, and clean patient-generated data as it flows in, so minimal data cleaning is needed at the study’s end.
This ability to “clean as you go” speeds up the process between the last patient out (LPO) and database lock (DBL). In fact, top virtual research organizations have achieved an average time between LPO and DBL of 7 to 10 business days.
To round off the clinical trial process, DCT components can accelerate the submission of required documentation to regulatory agencies. Required FDA, EMA, and HMA submissions are simplified when the data has already been gathered, catalogued, and interpreted in one central location.
As regulatory bodies increasingly encourage DCT adoption, sponsors can accelerate their go-to-market timelines by selectively incorporating virtual elements.
In a highly competitive industry, sponsors that can accelerate clinical trials have a clear advantage. Companies that adopt digital methods for recruiting, engaging, and supporting participants and study teams will be well-positioned for the future of therapeutic development.
With a full range of digital solutions for accelerating clinical trials, study teams can tailor a study protocol that is truly fit for purpose—and improve patients’ lives more rapidly than ever before.
Learn how virtual clinical trials elements can accelerate the entire clinical trial process.
ObvioHealth is a new breed of Virtual Research Organization (VRO) leading the long-overdue digitization and virtualization of health research to accelerate the development of innovative drugs and devices across the globe. Recently listed #390 on the list of Inc 5000's fastest growing companies, we are pioneering new ways to collect data, recruit, and engage patients and identify novel outcomes that help to bring life-improving health solutions to market, faster. Our patient-centric mobile application and platform enables subjects to use their smartphones, as well as wearables and other remote monitoring devices, to participate remotely in clinical trials from the comfort of their homes while delivering more cost-efficient and accurate data to sponsors.
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