Decentralized Clinical Trials
The emergence of innovative technology fueled by venture investment, the desire to reach more diverse populations, and the increased focus on patient-centricity have led sponsors of research and the sites where research is conducted to explore decentralized or virtual approaches to clinical trials. This trend has been further accelerated by the global pandemic which challenged the traditional brick-and-mortar site model. Decentralized clinical trials and the solutions and services that support them are still taking shape in the new research landscape. Learn what they are, how they impact your responsibilities, and explore solutions to challenges implementing decentralized clinical trials.
Positioned at the intersection of compliance, technology, and collaboration, Advarra can support your decentralized clinical trials efforts from study design to close-out via trusted services and solutions.
What is a Decentralized Clinical Trial?
What is a decentralized clinical trial?
With so much discussion surrounding decentralized clinical trials across the industry, it can be difficult to know what exactly a decentralized clinical trial is. To understand decentralized clinical trials, it is important to acknowledge what they are, but also what they are not. In summary:
A decentralized clinical trial is a non-traditional clinical trial model that utilizes technology and processes to create options for participation beyond an exclusive physical presence at research sites.
What is the difference between decentralized, virtual, hybrid, or remote clinical trial?
Terminology and assumptions vary within the industry. However, a core concept remains consistent – decentralized clinical trials fall on a spectrum of conduct and components.
- Traditional clinical trials encompass little to no remote or virtual elements and are conducted exclusively at brick and mortar research sites.
- Hybrid clinical trials implement any range of decentralized, virtual, or remote components of a clinical trial.
- Full virtual or fully remote clinical trials, operate as exclusively as possible outside of physical locations.
Decentralized can mean fully virtual or remote, or hybrid. No matter how you choose to approach or refer to decentralized clinical trials, it is important to understand the nuances of this evolving method and recognize their impact on the future of clinical research.
Why should you conduct decentralized clinical trials?
When executed intentionally and successfully, there are many operational, ethical, and regulatory benefits to conducting a decentralized clinical trial including:
- Access to wider, more geographically diverse pool of participants
- Increased participant recruitment, engagement, and retention
- Decreased burden on trial participants
- Stronger evidence package
- Efficient, centralized, and timely data collection
- Increased capacity for additional sites
- Support for future technology and process adoption to maintain research readiness
As the industry continues to adapt to remote and virtual workflows, additional benefits will be realized.
What are challenges to conducting a decentralized clinical trial?
Conducting decentralized clinical trials reduces burden and removes barriers for participants, but implementing decentralized modalities in clinical trials can require additional effort and commitment from sponsors and sites. Participant-centric research that occurs beyond a physical research site requires extra regulatory and operational infrastructure to ensure appropriate and successful conduct.
Regulatory Challenges:
- Inconsistent standards and guidelines
- Ensuring compliance (ex: 21 CRF Part 11, Facilitating GCP)
- Creation and adoption of new quality management systems
- Additional training and delegated tasks of inexperienced research staff (ex: home health nurses and smaller research sites)
- Virtual communication of amended study information to participants
- Maintenace of investigator delegation of authority
- Increased frequency of safety monitoring and remote monitoring access
- Data security and privacy
- Navigating varying geographic regulations
Operational Challenges:
- Potentially large initial investment in purchasing and testing of new technologies and processes
- Additional data management planning and design to accommodate for an increase in data collected, non-traditional data collection methods, data transfer, and archival.
- Adequate integration across all technology systems and study stakeholders.
To mitigate facing these challenges all at once, many sponsors and sites opt to implement a decentralized approach for components of their study. For example, adopting an eConsent system, a virtual visit system, home health visits, or any combination of virtual trial components.
What are the responsibilities of sites and sponsors in a decentralized trial?
Despite increased reliance on technology and virtual components of a decentralized and hybrid clinical trial, sponsors and sites still play a key role in the study design, planning, implementation, compliance, and oversight of the trial.
Subscribe to our resource library for upcoming discussion of roles and responsibilities in decentralized clinical trials.
Advarra Services and Solutions to Conduct Decentralized Clinical Trials
For Sponsors & CROs
Backed by our experienced consultants and review services, our integrated study management, site training, and participant engagement platform increases protocol compliance and facilitates virtual visits, to ensure successful and compliant virtual or hybrid study methodologies.
IRB & IBC Services
Experienced in evaluating DCT modalities effectively and efficiently, Advarra IRB and IBC services provide feedback on draft protocols, leverage DCT expertise to perform review knowledgably and efficiently, and utilize technology to communicate amended participant and protocol material.
Sponsor Technology
Supported by an intuitive, study-specific interface to ensure compliant and streamlined decentralized activities, the Longboat Platform enables management and visibility into study operations for study teams, facilitates secure virtual visits and tracks site training, and virtually engages participants with visit specific instructions, reminders, and consent guidance.
Consulting
Experienced in evaluating and planning DCT study design and process, Advarra’s trusted consultants ensure compliant study design and conduct, provides knowledge on best practices and regulatory guidelines, evaluates vendors and stakeholders, and supports internal training and education to maximize tech investments and clinical programs.
For Research Sites
Oversee and implement key elements of decentralized clinical trials from remote visits, regulatory document management, electronic consenting, and more via our integrated, compliant, and efficient solutions and services.
Site Technology
Supporting decentralized trial activities, Advarra Technology Solutions for sites ensures ability to adhere to protocol in a decentralized workflow via role-based access to documents, remote recruiting tools, remote monitoring, eSigning, in-app patient communication, HIPAA compliant video visits, and status alerts, while overseeing and maintaining regulatory compliance via 21 CFR Part 11 compliant eConsent, eSource, and eRegulatory Management solutions.
Consulting
Experienced in evaluating and planning DCT study design and process, Advarra’s trusted consultants ensure compliant study design and conduct, provides knowledge on best practices and regulatory guidelines, evaluates vendors and stakeholders, and supports internal training and education to maximize tech investments and clinical programs.
Professional Services
Advocating on behalf of research sites, Advarra Professional Services guides EDC study design to ensure accurate and appropriate collection of data to inform study outcomes, supports budget negotiation providing adequate funding to complete the trial, and guides adherence to protocols through accurate and efficient CTMS calendar building.
Explore Our Decentralized Clinical Trial Resources
Decentralized Clinical Trials Involving Biologics: Unique Challenges
Find out what FDA says about decentralized clinical trials and biologics, and what this means in practice.
Best Practices for IRB Review of DCTs: Expert Perspectives
Leverage best practices for IRB review of decentralized trial elements sourced from research community experts.
Decentralized Clinical Trials and Regulatory Changes
We discuss the evolution of decentralized trial modalities and possible solutions to regulatory challenges.
