Decentralized Clinical Trials

ARG’s decentralized clinical trial (DCT) model helps our sponsors recruit more diverse populations, retain more patients and discover more valuable data.

Decentralization Delivers Better Data For Faster Trials

Over the past decade, there has been a marked shift toward a more decentralized and patient-centric approach to clinical trials. In addition, the emergence of Covid-19 led to a drastic change in the life science landscape resulting in widespread adoption of decentralized trial methodologies across the industry.

Technology is already well-entrenched across all aspects of health care, so it should not be a surprise to imagine that the technology-based clinical trial model is becoming the standard. The guidelines released by regulatory authorities indicate the plausibility of using technology-driven studies to overcome the limitations of conventional trials.

Decentralization leverages technology to provide savings in every aspect of the clinical trial. Recruitment costs can be sustainably lower due to participation through ePro, wearable devices and telehealth visits. Administrative and site monitoring costs are reduced simply by lowering the number of site visits through the use of DDC and telehealth.

Benefits Of Decentralized Trials

The ARG Difference

Our scalable and platform-agnostic decentralized model help our sponsors:

  • Recruit more diverse participant populations
  • Retain more participants by focusing on the patient experience
  • Discover more valuable data

Mike Baker,
Senior VP of Business Development

The Benefits & Challenges Of DCTs

Differing from traditional clinical studies, Decentralized clinical trials (DCTs) employ a more patient-centric approach, which promotes higher trial participant recruitment and retention rates by minimizing barriers to participation. The study design also saves time for patients by reducing travel burden and utilizing engaging trial technologies.

The merits of DCTs are not limited to study participants only. Sponsors also benefit from decentralized trials with reduced costs, less travel time required, enhanced data accuracy, and real-time data monitoring.

Decentralized Clinical Study vs. Traditional Trials

DDCTs refer to human clinical studies carried out by local and mobile health care providers who use methodologies and technologies different from those in traditional clinical trials, such as telemedicine.

Unlike the traditional approaches, DCT focuses on incorporating local and mobile caregivers into clinical trials with the aid of novel data collection information technology.

9 Keys to Decentralized Trials

According to a June 2020 SCRS survey, only 40% of clinicians have participated in a hybrid DCT or a virtual clinical trial. This investigator reluctance to adoption by may be due to the perceived complexities of setting up and running decentralized trials.

Fortunately, DCTs don’t have to be complicated. Let’s review some of the best practices and key questions involved with decentralized trial design.

What is a Decentralized Clinical Trial?

Over the past decade, there has been a marked shift toward a more decentralized and patient-centric approach to Over the past decade, there has been a marked shift toward a more decentralized and patient-centric approach to clinical trials. In addition, the emergence of Covid-19 led to a drastic change in the clinical research landscape resulting in widespread adoption of decentralized trial methodologies across the industry. 

Technology is already well-entrenched across all aspects of health care, so it should not be a surprise to imagine that the technology-based clinical trial model is becoming the standard. The guidelines released by regulatory authorities indicate the plausibility of using technology-driven studies to overcome the limitations of conventional trials.

The FDA defines decentralized trials as technology-based human clinical trials that utilize telemedicine and mobile or local health care providers to gather data and which differ from the traditional design approach. In addition to advancing the patient experience, DCTs have the potential for reducing the cost of bringing new therapies into the market, costs which have nearly doubled over the years despite shortening study durations [1] .

A decentralized approach leverages technology to provide savings in every aspect of the clinical trial. Recruitment costs can be sustainably lower due to participation through ePro, wearable devices and telehealth visits. Administrative and site monitoring costs are reduced simply by lowering the number of site visits through the use of DDC and telehealth.

FDA Outlook on Decentralized Clinical Trials

Generally, the FDA is supportive of exercises that focus on modernizing clinical trial conduct and giving better study outcomes. In support of promoting faster development and review of medical therapies, the 21st Century Cures Act has expanded the FDA’s role in clinical trial oversight, which has led to the establishment of the Clinical Trials Transformation Initiative (CTTI).

FDA through the CTTI has issued guidance on the implementation of decentralized trials in a bid to speed up the release of novel treatments to the market and overcome the current barriers of traditional clinical trial designs [3].

EMA (Europe Medicines Agency) Outlook on Decentralized Clinical Trials

In an attempt to mitigate the effects of Covid-19 on the progress of clinical trials, the European Medicines Agency has In an attempt to mitigate the effects of Covid-19 on the progress of clinical trials, the European Medicines Agency has issued guidance on drug studies, recommending utilizing technology in some aspects of trials [4].

For instance, on-site visits should be minimized and offer the option of implementing telehealth visits. Changes in ways to obtain informed consent also serve to modernize the clinical trial approach. All of these measures are designed to prioritize and preserve patient safety.

Different Types of Decentralized Trials

DCTs utilize different approaches for various stakeholders. From direct-to-patient, siteless, virtual, remote to hybrid, the terms used to refer to the types of decentralized trials vary. Despite the various approaches, DCT models have two main categories: fully remote DCT and hybrid DCT.

  •  Fully Remote DCT: In this model, the study subjects take part in the trial entirely from their homes or any other convenient location. The recruitment and enrollment are done remotely with the participants filling the informed consent electronically. Digital health solutions are used to capture the patient data that are then transmitted over the internet. Studies with unique protocols such as sample collection can use locality-based, trained research nurses or techs to perform the procedures in the patients’ homes or local laboratories.
  • Hybrid DCT: A hybrid trial combines aspects of both traditional and decentralized clinical trials. The hybrid model is a middle ground that has become the favorite of pharma companies. It guarantees flexibility for clinical trial participants while maintaining study integrity similar to what can be found in a traditional trial. Clinical research studies requiring administration of particular investigational medical products in a hospital setting will find this approach quite favorable compared to the fully decentralized model.

The Difference Between Virtual and Decentralized

Both virtual and decentralized clinical trials utilize technology to increase study efficiency. It’s no wonder, these terms are often used interchangeably to refer to technology-based studies. However, according to official definitions, virtual studies differ from decentralized trials.

The term virtual trial became more recognized and utilized during the Covid-19 pandemic when the FDA released guidelines on conducting clinical trials during the crisis since most of the previous onsite activities now had to be done remotely. A strict definition of a virtual clinical trial would however mean an entirely technology-based study design in which no physical trial sites and face-to-face interactions exist.

On the other hand, decentralized trials have been around for a while with clear guidelines and definitions already in place. According to the FDA definition, decentralized clinical studies are more flexible and permit physical contact with the patient to some extent as seen in the hybrid sub-category. As early as 2011, decentralized trials were already being implemented by clinical trial operations teams.

 Hybrid vs Fully Decentralized Trials

Hybrid and fully decentralized studies are both types of DCTs that utilize technology to offer patient-centric approaches Hybrid trials and fully decentralized studies are both types of DCTs that utilize technology to offer patient-centric approaches in clinical trials. Their focus is to relieve the participant burden primarily associated with traveling. Depending on the study protocol, it specifically dictates the trial mechanics. For instance, if a study aims to achieve significant patient convenience while retaining minimal on-site visits for particular assessments, a hybrid approach is the best fit. On the contrary, fully decentralized trials do not conduct on-site visits and all subject data are collected remotely.

 Traditional Clinical Trial vs Decentralized Clinical Trial

With the development of digital health technologies, clinical trials are taking a patient-centric approach in ways different from the traditional site-based model. DCTs are characterized by minimal dependence on conventional research centers and the support of intermediaries in the collection of data. Instead, decentralized trials hinge on virtual solutions such as telemedicine, wearable devices, and other telehealth services to obtain patient information [2].

Most aspects of decentralized studies are remote, from participant recruitment to administration of investigational medical products, to collection of data, all occurring with limited or no face-to-face contact between the subjects and study team.

In contrast, traditional clinical trials solely depend on physical contact between the participants and investigators for success. Patients typically sign the informed consent on-site before being enrolled in the study and they also visit the trial research center in person at specific intervals for assessment and data reporting.

Noteworthy, the majority of current clinical trials incorporate elements of these two study designs as a way of relieving participant burden while maintaining recommended trial integrity and quality.

Technology Uses in Decentralized Clinical Trials

Decentralized solutions employ technology in various aspects of studies, such as electronic informed consent (eConsent), electronic patient-reported outcomes (ePRO), telemedicine, and electronic clinical outcomes assessment (eCOA). The eConsent is a web-based tool for obtaining consent from prospective study participants. Signing the consent marks enrollment in the clinical trial. ePRO and eCOA are strategies for capturing patient data during the study.

Telemedicine is a video conferencing technology that makes it possible for trial investigators to interact with the patients virtually. Bring-your-own-device, or BYOD, allows participants to use their own devices in submitting information to the study center.

 Collection Methods

Data collection in decentralized clinical trials is an automated process that captures patient information from wearable Data collection in decentralized clinical trials is an automated process that captures patient information from wearable medical devices, patient e-diaries, or clinical outcomes assessment platforms (ePRO and eCOA) [5] . The collected patient data is transmitted over the internet to a central database.

Benefits of Decentralized Clinical Trials for Sponsors

This model also has benefits for sponsors. Decentralized clinical studies speed up the development of new therapies by reducing attrition rates and providing access to a more diverse patient population. Again, it allows for real-time monitoring of patient data, which increases study efficiency and data quality. Another significant benefit to the sponsors is that clinical operations funds can be reallocated to other aspects of the study. 

Benefits of Decentralized Clinical Trials for Patients

Decentralized studies shift the clinical trial landscape from the research center-focused traditional designs to a patient-focused model. For patients, DCTs save both time and money while offering convenience. DCTs relieve the patient burden by eliminating the need to visit study sites regularly which consequently reduces costs associated with travel. Since data is collected remotely via digital technology, decentralized trials limit disruption of participants’ family and work life, a factor that can promote retention. Patient centricity fosters clinical trial participation.

Challenges in Running Decentralized Clinical Trials

Despite the potential benefits associated with DCTs, this approach has a few issues that need to be addressed. Decentralized trials often face the challenge of data protection. Decentralized trials need to put in place measures that protect patient data from intrusion such as data encryption.

Another challenge that DCTs face is technology integration. The sponsors and CROs introduce different technological systems that can confuse patients. For the success of decentralized trials, the study team needs to come up with a way of integrating these systems into one.

Patients differ and there is no one size fits all. While some patients feel burdened to travel to the research sites, some patients love meeting the HCPs for face-to-face interactions. Moving forward, trials should offer various approaches to meet the needs of each study participant.

Another often overlooked challenge when conducting DCTs is the need for translation services for global studies. The translation services are in most cases sophisticated and complicate the outcome of the studies. 

Decentralization Works Through Collaboration

In the implementation of decentralized clinical studies, it is essential to consider the design from three points of view: In the implementation of decentralized clinical studies, it is essential to consider the design from three points of view: the patient, the site, and the sponsor. The utilization of technology should ease the patient’s journey rather than complicate it.

Conducting user acceptance testing, designing user-friendly devices and mapping patient journeys are some of the ways sponsors can ensure the patient burden is minimal. Understanding how sites are willing and able to support throughout a study will also help DCTs to expand access as intended. Lastly, a collaboration of the sponsors with other stakeholders can help alleviate challenges such as systems interoperability.


References
  1. https://www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-lshc-r-and-d-pharmaceuticals-roi-2017.pdf
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8093545/
  3. https://www.ctti-clinicaltrials.org/sites/www.ctti-clinicaltrials.org/files/dct_recommendations_final.pdf
  4. https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
  5. https://pubmed.ncbi.nlm.nih.gov/27249775/