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.

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Accelerating Clinical Trials: How DCT Components Shorten Trial Timelines

Decentralized components can support and accelerate every stage of a trial, significantly decreasing the time to completion without compromising safety or quality.

Here’s how:

• Optimizing study designs shorten the start-up phase.
• Faster recruitment and enrollment saves patients time.
• ePRO and eCOA drive faster data collection and assessment.
• Digitized data management reduces time to database lock.
• Efficient regulatory submissions accelerate clinical trials.  

Let’s explore each step to understand how decentralization drives efficiency throughout the clinical trial process.

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Optimizing Study Design Shortens the Start-Up Phase

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:

• Speed up enrollment through digital recruitment and prescreening.
• Leverage ePRO to efficiently collect diaries and symptomology reporting from patients at home.
• Reserve site-based assessments for 1 to 2 scheduled appointments.

Similarly, a digital health device study team may:

• Organize in-person dispensation, collection, and device training at a major university medical center.
• Leverage audio, image, and video capture to accelerate data collection during the usage phase of the trial.

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.

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Faster Recruitment and Enrollment Save Patients Time

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:

• Reviewing educational material about the trial.  
• Completing prescreening questions to determine their eligibility.
• Applying and enrolling in the study using digital tools like eConsent.
• Completing onboarding, supported by online trial training.
• Contacting virtual site support coordinators when and if they have questions or concerns.

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.

‍Discover how DCT elements accelerate the recruitment process or read further on Clinical Trial Enrollment

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ePRO and eCOA Drive Faster Data Collection and Assessment

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.

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Centralized, Clean Data Reduces Time to Database Lock

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.  

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Efficient Regulatory Submissions Accelerate Clinical Trials

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.

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Accelerating Clinical Trials Conclusion

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.

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