Understanding Decentralized Clinical Trials

Gain a better understanding of decentralized clinical trials (DCTs) by listening to the embedded audio clips of Veristat’s Shaheen Limbada, Executive Vice President, Innovation and Strategy, as he defines DCTs, describes use cases and the benefits they offer. Click on the play buttons to listen below.


WHY DECENTRALIZED TRIALS? WHY NOW?

The clinical trial landscape continually adapts its focus on patient-centric practices to improve clinical trial participation by reducing patients’ burden. Over the past few years, this shift has focused on bringing the clinical trial to the patient’s home, a clear disruption of trial conduct today. Adoption has not been widespread; however, the COVID-19 pandemic shifted the need to adopt this change quickly.


WHAT ARE DECENTRALIZED TRIALS?   LISTEN >  
 

Everyone refers to and defines decentralized trials differently because we can virtualize many aspects of clinical trials. So, at what point is a trial considered “decentralized”?

At Veristat, a decentralized trial eases patients’ burden by delivering the clinical trial directly to them. Specifically, patient interactions occur remotely in the home, or through a hybrid combination of visits held at home, on-site, or at community testing centers.

 

Decentralized Trials Nomenclature
◆  Virtual (Clinical) Trials ◆  At-home Trials ◆  Home Clinical Trials
◆  Remote (Clinical) Trials ◆  Clinical Trials at Home ◆  Direct to Patient Trials (DTP)
◆  Decentralized Trials (DCT) ◆  Clinical Trials from Home ◆  Hybrid Virtual Trials

 

THE DECENTRALIZED CLINICAL TRIALS CONTINUUM

 

LISTEN >  

 

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  • Patient travels to site for all visits
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  • Patient participates with a combination of at-home and on-site visits
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  • Patients participate in the trial fully from home
  • No on-site visits

The COVID-19 pandemic disrupted the traditional clinical trial model, requiring a virtual approach.  Now,  in the post-pandemic world,  we see continued and expanded adoption of a highly customized and flexible decentralized trial model. Leveraging virtual trial tools and strategies supports our patient-centric approach by reducing the burden on patients while continuing to deliver efficient and superior quality clinical trials.”


- Shaheen Limbada, Executive Vice President, Innovation and Strategy, Veristat

 

 



THE DECENTRALIZED TRIALS ECOSYSTEM TOOL KIT, INCLUDING
SPECIALIZED TECHNOLOGY:

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THE FULL EXPERIENCE - HYBRID DECENTRALIZED TRIAL MODEL                                  LISTEN >

The Patient's Journey Through the Virtual Clinical Trial Experience

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A Hybrid Decentralized Approach Gives You Flexibility

The hybrid solution is completely customizable to the needs of the patients, sites, and protocol. This is just one example – there can be any combination of visits at the site, at-home, or both throughout the duration of the trial.

 


DECENTRALIZED TRIAL BENEFITS                                                        LISTEN >  

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Improves patient-centricity of trial by reducing travel/time burden on patients

 

 

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Broadens access to patient populations to be more diverse and inclusive – patient access is less restricted by geography

 

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Improves flexibility – trials can be customized to be completely site-less,

all onsite or a hybrid 

 

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Potentially saves time and cost across development from reduced cycle times, improved patient screening and enrollment, and fewer protocol amendments over the life of a trial (as revealed by a recent Tufts CSDD study).

 

Overall, decentralized trials improve patient recruitment and retention, which, in

turn increases trial efficiency to save time and cost.

 

Meet Veristat – Implement Your Decentralized Trials Right, the First Time

We understand how challenging it is to adopt a new way of conducting clinical trials. Pivoting to decentralized clinical trials is no exception. We have the agility and scientific-minded experts to help you navigate this novel approach to clinical development.

 

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