How Are Clinical Trials Being Decentralized in 2022?

Thanks to the steady stream of research and new technologies, the medical field is continuously evolving. Strategies such as outsourcing medical bills and engaging in telehealth visits have become more widespread. In recent years, decentralization has played a key role in this continuing evolution.

Medical practices and patient treatment have become increasingly decentralized in recent years. Patients needed to attend appointments at a physical office, but that isn’t necessarily the case anymore. Especially in the wake of COVID-19, there is now a wide selection of remote possibilities for those seeking medical care or diagnosis without the need to travel to a hospital or clinic.

As a whole, decentralization introduces a new paradigm in the world of medicine.^[1]Abimbola, S., Baatiema, L., & Bigdeli, M. (2019). The impacts of decentralization on health system equity, efficiency and resilience: a realist synthesis of the evidence. Health policy and … Continue reading This is a way for patients to access traditional solutions in the comfort of their own homes. Perhaps even more notable is that patients can also have new technologies and medical procedures brought directly to them via digital or electronic means, without the need for an in-person doctor’s visit.

As decentralization becomes a more popular approach to medical care, we’ve seen major developments in the healthcare industry as a whole. Of particular interest is the impact decentralization has had on the medical research community.^[2]Van Norman G. A. (2021). Decentralized Clinical Trials: The Future of Medical Product Development?∗. JACC. Basic to translational science, 6(4), 384–387. … Continue reading Decentralization of clinical trials is at the forefront of this phenomenon.

What Are Decentralized Clinical Trials?

Decentralized clinical trials are an especially revolutionary addition to traditional medical research. Using remote methods, researchers deliver the trial’s activities to the patients rather than having patients travel to a research site. For this to work as intended, participants are provided technologies that allow them to record data and communicate with researchers.

Examples of technologies commonly used in decentralized clinical trials are:

• Patient apps for phones and tablets
• Specialized smartphones
• Wearable digital health devices

Additionally, for researchers to successfully communicate with study participants, they may consider involving their personal physician, mobile healthcare providers, or telemedicine.

What Are the Benefits of Decentralized Clinical Trials?

There are many benefits that come with the decentralization of clinical trials. Using this new paradigm, the decentralization of clinical trials allows physicians and researchers to meet patients where they are.

Benefits include:

Reduced Travel Concerns

In the United States, it isn’t uncommon for study participants to reside two or more hours away from a given trial site. Traditional clinical trials can also come with a heavy cost burden, including the price of lodging, transportation, meals, and more. With a decentralized trial, it is far easier for the trial to fit the limitations of the participating individuals. Decentralized trials significantly reduce travel and cost burdens without subsequently placing them on the trial’s host.

Better Retention Rates

Excessive travel and expenses are extremely inconvenient for many potential participants, limiting centralized trial access to a much smaller group of people. However, decentralized trials allow patients to participate without excess travel and costs.

For this reason, when trials are decentralized, patient recruitment can be accelerated, and the rate of drop-outs can be significantly reduced.

Increased Diversity

The limiting factors listed above can also make the patient pool for a centralized trial less diverse. Because the recruitment for a decentralized trial is open to a wider group of patients, this can help improve diversity within the patient population.

Limited Face-to-Face Interactions

Perhaps unsurprisingly, since the spread of COVID-19 began, the idea of decentralizing clinical trials has drawn more attention than ever before. With a traditional in-person trial, participants must come into close contact with a wide variety of individuals, including the researchers conducting the trials and other participants. When researchers opt for decentralized clinical trials, they are reducing or outright eliminating the need to come into contact with others.

Improved Data Collection

Frequent data collection is also more feasible with decentralized clinical trials. If researchers would like to collect data and monitor patients, they no longer need to meet with them on-site. This makes it possible for researchers to not only reduce the cost of performing a study but also help new medications get to market much faster.

Reduced Workload

With traditional clinical trials, trial investigators are faced with a more substantial workload than with decentralized trials. Historically, investigators would need to be available on-site to perform essential tasks such as assessments, drug administration, data verification, and more. If a decentralized trial system is used instead, all these duties can be performed remotely by the trial participants or other individuals rather than the investigators.

Decentralized Vs. Virtual Clinical Trials: Is There a Difference?

Decentralized and virtual clinical trials are not synonymous, nor are they mutually exclusive. In fact, it’s possible for the two to overlap. It’s possible for a virtual trial to be decentralized, much like it’s possible for a decentralized clinical trial to utilize digital tools and technologies. However, it’s important to recognize that these terms carry some key distinctions.

Decentralized Trials

The core characteristic of decentralized trials is simple—they must take place at a location other than a designated research facility. Instead, the trial can be completed at a remote location, whether it’s a remote trial conducted virtually, a remote trial at a local site, or a combination of remote and on-site (commonly known as a hybrid clinical trial). Virtual tools and technology are commonly used in decentralized trials, but they aren’t a prerequisite. It’s even acceptable for decentralized trials to employ house calls or paper-based assessments sent and received in the mail.

Some decentralized trials use digital tools to perform their research. For example, many decentralized trials utilize electronic assessments and video calls to gather data about their participants. However, it’s also possible for a centralized clinical trial to rely on face-to-face interaction at the local level near the patient’s home. All that matters is the location where this interaction is taking place.

Virtual or Digital Trials

A virtual clinical trial, also known as a digital clinical trial, is dependent on the use of virtual technology.^[3]Thakur, S., & Lahiry, S. (2021). Digital clinical trial: A new norm in clinical research. Perspectives in clinical research, 12(4), 184–188. https://doi.org/10.4103/picr.PICR_278_20 Although participants in a virtual clinical trial may be required to complete physical paperwork before the start of the study, once the trial has commenced, the primary data capture method is digital.

Typically, a virtual clinical trial will be composed of the following elements:

• Virtual protocol
• eScreening systems
• Digital IRB packages
• Various linked systems
• eConsent systems
• Digital case report forms (or eCRFs)

Decentralized Clinical Trials in 2022: What Can Healthcare Professionals Expect?

Out of necessity, many researchers turned to decentralization, allowing them to continue performing important research despite the limitations caused by COVID-19.^[4]Moynihan R, Sanders S, Michaleff ZA, et al.Impact of COVID-19 pandemic on utilisation of healthcare services: a systematic review. BMJ Open 2021;11:e045343. doi:10.1136/bmjopen-2020-045343 Further, many resources in the healthcare system were being consumed by pandemic-related care. Decentralized clinical trials require fewer of these resources to operate.

Due to the sudden and rapid decline of trial activities during the first half of 2020, it was critical for investigators to intervene as quickly as possible. Without this intervention, data integrity and the continuity of care could have been put at risk. Ultimately, this led to the increased adoption of tools like remote consent forms and patient monitoring, at-home phlebotomy, video conference assessments, and more, depending on the needs of the study.

The virtualization and decentralization of clinical trials have been accelerated by the COVID-19 pandemic. In 2022, healthcare professionals will continue to feel these effects. In fact, although decentralization techniques were popularized as urgent interventions, it’s probable that they will be transformed into permanent fixtures of healthcare.

The Near Future of Fully Virtual Trials in 2022

As mentioned, certain decentralized clinical trials are performed one hundred percent virtually. In contrast, other decentralized trials have adopted a hybrid method, mixing in-person procedures with remote methods of data tracking. During a hybrid trial, the participants will be required to visit an in-person facility on occasion. The frequency of these visits can vary, depending on the needs of the study and the number of complex procedures involved.

A fully virtual trial, however, involves self-administration of medications and end-to-end virtual tools. Additionally, both enrollment and assessment procedures must occur remotely. In the recent past, applications for fully virtual clinical trials were limited. Typically, this model would have been used primarily to complete small, early phase studies, as well as post-approval studies. However, this seems to be changing slightly.

It’s becoming increasingly normal for fully virtual trials to be incorporated into larger, more pivotal research studies. In 2022, it’s reasonable to expect that fully virtual trials will continue to be used in limited scenarios.^[5]Iyengar, K., Mabrouk, A., Jain, V. K., Venkatesan, A., & Vaishya, R. (2020). Learning opportunities from COVID-19 and future effects on health care system. Diabetes & metabolic syndrome, … Continue reading For example, a fully virtual study could be employed to research a well-characterized medication. It’s also crucial to note that fully virtual studies have endpoints that are compatible with remote forms of measurement.

For the time being, the majority of decentralized trials aren’t digital from end to end. Hybrid studies are also continuing to rise in prevalence. According to research published by Industry Standard Research, over two-thirds of survey respondents claimed that they have used hybrid trial methods or plan to use these methods within the next two years. More specifically, 31% of respondents said that they plan to use hybrid trials for at least 40% of their studies within two years, while 14% stated that they already had.

What Can Complicate Decentralized Clinical Trials?

Although decentralization makes many trials simpler to perform, they can also come with complications. Currently, clinical trial regulations haven’t kept up with the developing technologies and tools used during decentralized trials. This makes it necessary for investigators to establish their own procedures suited to a decentralized environment. Procedure changes could involve determining how investigational drugs can be delivered to participants safely and in a way that’s compliant with all protocols of the study.

Wearables can also leave researchers faced with a high volume of data.^[6]Lu, L., Zhang, J., Xie, Y., Gao, F., Xu, S., Wu, X., & Ye, Z. (2020). Wearable Health Devices in Health Care: Narrative Systematic Review. JMIR mHealth and uHealth, 8(11), e18907. … Continue reading For this reason, investigators have needed to develop new methods of managing data from trials.

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