The adoption of digital health technologies (DHTs) in the industry continues to pave the way to enable decentralized clinical trials (DCTs). Participants' needs and convenience are main drivers behind these technologies, and electronic clinical outcome assessments (eCOAs), along with digital endpoints, are becoming more commonplace. Every pharma and biotech company has an invested interest in the Internet of Medical Things (IoMT) — which includes medical devices, wearable devices, sensors and apps that connect to health care information systems. IoMT uses the technology consumers have available to them to enable DCTs and allow sponsor companies to keep trial participants safe, healthy and connected. Patient centricity is considered first and foremost in today's clinical trials landscape, and IoMT and DCTs allow sponsors to rethink and revolutionize the clinical trial experience and ultimately provide novel and improved treatments faster to the patients who need them the most.
The digitally transformed DCT experience
Clinical trials are inherently costly and complex, and many lack diversity by failing to represent diverse populations, including those from minority backgrounds. The industry has been slowly transitioning away from traditional clinical trials for over a decade by including aspects of decentralization, and the COVID-19 pandemic has now irreversibly catalyzed this trend.
Dr. Isaac R. Rodriguez-Chavez, senior vice president for scientific and clinical affairs, leading the strategy of the Global Center of Excellence for Decentralized Clinical Trials at PRA Health Sciences, explained this trend. "We are essentially transitioning from traditional clinical trials conducted at the brick-and-mortar sites to the implementation of multiple levels of decentralization of activities for many clinical investigations. Catalyzed by COVID-19, the phenomenon that we are seeing is historic, transformative and we are at a transitional point of permanent change in clinical research."
DHTs facilitate decentralization in clinical trials, and with a variety of tools — such as mobile health, health information technology, wearable devices, telehealth and telemedicine — the options are seemingly endless. Dr. Rodriguez-Chavez said there is a spectrum to the modernization of clinical research. It starts with maintaining the traditional trials and adding on some telehealth visits and technology for optimization. This creates a hybrid DCT in which there are some elements of decentralization. Then, ends with fully decentralized clinical trials enabled by technology, in which all activities are conducted remotely from the brick-and-mortar site and the investigator.
"In a DCT, the clinical research site exists in a different way compared to a brick-and-mortar site. It's not a building that participants go to, it is essentially a whole system of remote places where DCT personnel (i.e., investigator, sub-investigators, and trial staff), local health care providers and services as well as participants engage in the DCT," Dr. Rodriguez-Chavez said.
DCTs provide participant centricity and enable inclusivity and democratization
A major advantage of DCTs is the convenience for trial participants. This is a huge driving force behind the widespread adoption of DCTs today. Dr. Rodriguez-Chavez emphasized, "We, the consumers, are the ones driving these transformations. DCTs are the new norm because they are less disruptive of our lives as we're able to stay in our homes, in our towns, in our cities. We don't have to travel far away to participate in a clinical investigation." Then, there is the inclusivity and democratization that DCTs afford. "We're breaking geographic barriers and giving access to diverse populations, including minority populations that represent the current makeup of countries and societies. This is really essential so that we can understand, in real-world settings and with generalizable data, the safety and efficacy of all investigational medical products that are being assessed in clinical investigations," Dr. Rodriguez-Chavez said.
Accelerated speeds, high-quality data and improved efficiency
Using electronic medical records to identify appropriate subjects based on a protocol's inclusion and exclusion criteria, and adopting electronic informed consent processes are just some of the approaches used in DCTs to improve the efficiency and accelerate recruitment and enrollment. IoMT allows for more continuous monitoring as specified in a DCT protocol and provides a constant stream of high-quality, real-world data while maintaining trial participants' safety. The result is a more holistic view of trial participants' health, and the potential for a more comprehensive data set obtained in a DCT, which will likely be superior to the episodic data collected in a traditional clinical trial, Dr. Rodriguez-Chavez noted.
"There is an initial investment that needs to happen in order to optimize all the steps so that DCTs overall become more efficient in the long term," Dr. Rodriguez-Chavez said. "We at PRA Health Sciences look very carefully into how to optimize DCTs in all the steps that are involved from — early on planning, protocol design, implementation and post-market activities — so that we actually deliver excellent end-to-end, customized services to our sponsors."
Automated, high quality data collection and monitoring that happens in DCTs support participants' safety, early decision-making and adaptive changes, which can ultimately accelerate development. This provides a winning situation for both the trial participants and the sponsor.
As the number of connected devices increases, there has been a parallel increase in cybersecurity risk. In addition, as IoMT becomes more complex and advanced, there is the increased difficulty for validating devices and digital endpoints. Regulations will continue to be updated and revised, and most countries have struggled to keep pace with rapid science and technology developments. DCTs provide the opportunity to conduct global studies, but this comes with its own challenges.
"When deploying DCTs at a global level, there is a need to understand and comply with the regulations and the laws at the local jurisdictional level for each different country involved in the trial. At PRA Health Sciences, we have experts and DCT regulatory intelligence at the global level so that we essentially assess the regulatory feasibility of deploying decentralized activities for our DCTs to maximize success and mitigate risks," Dr. Rodriguez-Chavez said.
The FDA recognizes the difficulties encountered when navigating the digital health arena linked to clinical research and has established a Digital Health Center of Excellence (DHCoE). The mission of the DHCoE is to align and coordinate digital health work across the FDA, and it marks the beginning of a comprehensive approach to DHTs, setting the stage for advancing and realizing the potential of digital health. Dr. Rodriguez-Chavez explained that in his experience the FDA is at the forefront in terms of global regulation, supporting DCTs. "Overall, the FDA is fully supportive and on-board in creating a regulatory road map for DCTs."
Future and innovation in DCTs
These are exciting times as sponsor companies leverage the advantages of DHTs and DCTs to provide life-changing therapies to trial participants. Dr. Rodriguez-Chavez outlined two major areas that he believes will be at the forefront of DCT innovation.
Increased integration and sophistication of DHTs used in DCTs. "At PRA Health Sciences, we possess a foundational architecture of technology. That is essentially the ground base of technology required to provide multifunctional, integrative and interoperable services with increased sophistication, combined with a reliable power for analytics that can be customized to the needs of each DCT" Dr. Rodriguez-Chavez said.
DCTs as a care option. DCTs bring treatments to trial participants and patients faster and more conveniently. Participants directly benefit from novel medical products under investigation by being part of clinical research as a health care option, and this will be a defining concept in the years to come. At the same time, patients using the standard health care systems may be identified and join DCTs. This way we leverage DCTs as a health care option and utilize the standard health care systems for everyone's benefit.
"We are the only Healthcare Intelligence Organization in the market working on the unification of DCTs as a care option together with the health care systems. We call this critical principle CRAACO, short for Clinical Research As A Care Option," Dr. Rodriguez-Chavez said. "It is a combination of the best of two worlds, and we at PRA are very proud to deliver this concept in a customized fashion to our clients and partners." CRAACO unifies DCTs as a health care option and the use of standard health care systems, so that patients and trial participants benefit from both synchronously.
Interested in learning more about hybrid decentralized trials (DCTs) and fully decentralized trials, and how you can incorporate them into your clinical development? Visit prahs.com/dct to find out how and speak with one of our experts today.