What the Increase in Decentralized Clinical Trials Means for Your Business

Before COVID-19, decentralized clinical trials (DCTs) adoption was slow due to regulatory factors, technological limitations, and resistance to change within the clinical research community. Since then,  the pandemic has acted as a catalyst for the growth of DCTs.

Due to the pandemic, many ongoing clinical trials have faced disruptions due to restrictions on participant travel. As a result, researchers and sponsors quickly adapted their trial protocols to incorporate remote and decentralized approaches. This led to increased adoption of DCTs across a wide range of therapeutic areas. This article discusses the development of decentralized clinical trials and how companies can benefit from their increased prevalence.

What are Decentralized Clinical Trials?

Decentralized Clinical Trials are virtual or remote and leverage technology and digital health tools to collect data, reducing the need for participants to visit physical sites. DCTs make clinical trials more patient-centric, efficient, and accessible, reducing patients' geographical barriers and burdens.  

The Growth of Decentralized Clinical Trials

Technological advances such as real-time monitoring and remote data collection have allowed DCTs to grow. In addition to convenience, this advancement includes the increasing availability of proper data security, privacy protection, and adherence to regulatory requirements through robust and secure digital infrastructure and data transmission. 

Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have issued guidance and recommendations to facilitate remote monitoring, telemedicine, and electronic data capture. As recently as May 2023, the FDA issued a draft guidance regarding DCTs for drugs, biological products, and devices. The draft guidance expands on the agency's recommendations in March 2020 to facilitate trial decentralization in response to the pandemic. In general, the May 2023 draft requirements are the same as those for traditional site-based clinical trials but include added recommendations regarding sponsors, investigators, and other stakeholders and how they can satisfy regulatory obligations in the future.

Additional technological advancements such as telemedicine platforms, wearable devices, and mobile applications have allowed for the remote collection and monitoring of clinical trial data. These technologies have become more accessible, reliable, and user-friendly, empowering participants to be actively involved in their health care. Some of these apps and devices include reminders and personalized feedback that act as motivation to adhere to the study's protocols. Features that can be included are screen readers, closed captioning, and voice commands, promoting increasing inclusivity and a broader range of participants.

The Benefits & Challenges of DCTs

Decentralized Clinical Trials offer significant benefits to participants, such as reduced travel, more convenience, and increased access to clinical trials. This patient-focused approach has gained support from participants and advocacy groups alike.

DCTs have also shown reduced costs associated with site infrastructure, travel expenses, and data collection. They offer the possibility of faster participant enrollment and data collection, which may lead to quicker trial timelines. 

While there are many benefits to DCTs, there are some challenges. Inadequate technology or network interruptions can compromise the integrity of a trial. Additionally, although DCTs are designed to be patient-centric, many participants can feel less connected, resulting in higher dropout rates and incomplete data submissions. While DCTs aim to access a wider pool of participants, individuals with limited technology access or digital literacy may encounter difficulties participating.

In addition, as with any system that relies on data transfer and storage, DCTs are not immune to cyber and data breaches. This introduces the risk of cyberattacks, including hacking, data breaches, and unauthorized access to personal health information. Data breaches can occur due to inadequate security measures, human error, or insider threats, leading to privacy violations.

How DCTs Impact Your Business

A successful DCT can significantly impact a business involved in clinical research. DCTs streamline the entire process and reduce operational costs by eliminating physical trial sites. By eliminating a physical trial site, clinical trials can expand beyond their immediate geographic location and enlist diverse participants, leading to a better data pool. Reducing the burden of frequent site visits can enhance participant engagement and increase retention. Quality technology enables data collection regardless of location and reduces the likelihood of errors due to manual entry. Lastly, DCTs allow collaboration and encourage the development of strategic alliances across research centers, providing a competitive edge as a differentiator in the clinical research market. 

If you'd like to learn more, Berkley Life Sciences recently moderated a webinar titled "How Decentralized Clinical Trials Are Changing the Clinical Trial Landscape," presented by Dr. Clare Grace, Chief Patient Officer at Parexel, and Kyle Faget, Partner at Foley and Lardner. They discussed compelling information regarding the shifting landscape of DCTs - such as licensing, practice standards, use of digital health technology, and telemedicine protocols - and the benefits and challenges of this hybrid approach.

Authored by Christopher Dorko, ARM, ARM-PE, CFPS, CHMM

_____________________________________________________________________________________

Products and services are provided by one or more insurance company subsidiaries of W. R. Berkley Corporation. Not all products and services are available in every jurisdiction. Certain coverages may be provided through surplus lines insurance company subsidiaries of W. R. Berkley Corporation through licensed surplus lines brokers. Surplus lines insurers do not generally participate in state guaranty funds, and insureds are, therefore, not protected by such funds.  In California, Berkley Life Sciences conducts business as Berkley LS Insurance Solutions, LLC, a licensed surplus lines broker (License Number 0H44165).

All information provided, including any reference to insurance, is descriptive and presented for discussion purposes only and is not offered as legal, accounting, or other professional advice. Coverage afforded under any insurance policy issued is subject to the individual terms and conditions of that policy as issued. Claims scenarios are hypothetical in nature and for illustrative purposes. 

©2023 Berkley Life Sciences, a Berkley Company. All Rights Reserved.

________________________________________________________________________________________________________