No place like home? the decentralization of clinical trials

Digital technology has revolutionized the way clinical trials are conducted, making them more efficient and streamlined than ever before. One of the most significant advances in this field has been the development of decentralized clinical trials (DCTs), which allow for the participation of patients from remote locations and the collection of data in real-time.

DCTs —also termed “direct-to-participant trials” or “virtual” studies— are characterized by less dependence on traditional research?facilities or specialist intermediaries for data collection. DCTs leverage “virtual” tools, such as telemedicine, sensory-based technologies, wearable medical devices, home visits, patient-driven virtual health care interfaces, and direct delivery of study drugs and materials to patients’ homes. DCTs rely heavily on digital platforms to facilitate the collection, storage, and analysis of data.

These platforms provide a centralized location for all trial-related information, making it easy for researchers to access and analyze data from multiple locations. Additionally, digital DCT platforms allow for the recruitment of patients through online portals, reducing the need for face-to-face visits and increasing the number of patients who can participate in a trial.

One of the key features of a digital DCT platform is the ability to remotely monitor patients. This is done through the use of wearable devices and mobile apps that allow patients to record their symptoms and other information in real-time. This data is then transmitted to the digital platform, where it can be analyzed and used to make decisions about the trial.

Another important feature of a digital DCT platform is the ability to manage patient data in a secure and compliant manner. This includes the ability to encrypt data, ensure compliance with regulations, and provide access controls to ensure that only authorized personnel can access patient data.

Digital DCT platforms also offer a range of analytics tools that allow researchers to analyze data in real-time. This includes tools for data visualization, machine learning, and predictive analytics. These tools can be used to identify patterns in patient data, which can help researchers make decisions about the trial.

Trust is a key success factor for decentralized clinical trials

A significant amount of traditional clinical trials?are?abandoned because they either are unable to attract sufficient participants or because they lose participants along the way. An 埃森哲 research has shown DCT can help solve for this in a number of ways:??

52% improved patient recruitment

48% improved patient retention

40% increase in speed of drug development

It is also largely expected that DCT will also help improve health equity by providing greater access to clinical trials for patients who may have previously been excluded. Here are some key ways in which DCTs can help improve health equity:

1. Increased accessibility: DCTs allow patients to participate in clinical trials from the comfort of their own homes, reducing the need for travel to clinical trial sites. This can be particularly beneficial for patients who live in rural or underserved areas, who may not have access to clinical trial sites.
2. Reduced barriers to participation: DCTs can reduce barriers to participation in clinical trials, such as the cost of travel and time away from work. This can help increase the diversity of participants in clinical trials, which can help improve health equity. For example, according to FDA CDER data, 75% of participants in drug trials were white in 2020—yet the population demographics in the US have shifted significantly over the past decade. Between 2010 and 2020, the Hispanic or Latino population grew by 23%, while the multiracial population grew 276% in the same period1.??
3. Increased patient engagement: DCTs can increase patient engagement by providing a more convenient and less intrusive way to participate in clinical trials. This can help reduce the drop-out rate, which can help improve health equity.

In order to increase DCT engagement, life sciences companies need to ensure that the data that is being collected is deeply protected—and digital platforms that enable data collection are persistently and securely available. With the rise of digital tools such as wearables, the amount of data that can be collected has expanded significantly, creating more dynamic data sets.??

What are the main companies acting in the decentralised clinical trials (DCTs)?

There are several companies that are actively involved in the development and implementation of decentralized clinical trials (DCTs). Some of the main companies include:

1. Medidata Solutions
2. 艾昆纬
3. Labcorp
4. PRA Health Sciences
5. 精鼎医药
6. ICON plc
7. 甲骨文
8. CRF HEALTH GROUP LIMITED
9. Clinical ink
10. Medable, Inc
11. Science 37

Global Decentralized Clinical Trials (#DCTs) key players include Medidata, IQVIA, Labcorp, PRA Health Sciences, Parexel, etc. Global top five manufacturers hold a share over 45%.

These are just a few of the main companies involved in DCTs. There are many more companies and startups that are developing innovative solutions for the management and implementation of DCTs. The field of DCTs is rapidly evolving, and there are likely to be many more players entering the market in the near future.

What is the size of the DCTs market?

According to a recent report, the global decentralized clinical trials (DCTs) market size is projected to reach US$ 16290 million by 2027, from US$ 6106 million in 2020, at a CAGR of 14.8% during 2021-2027.

The growth of the DCTs market can be attributed to several factors, including the increasing demand for remote patient monitoring, the growth of the digital health market, and the need for more efficient and cost-effective clinical trials. Additionally, the COVID-19 pandemic has accelerated the adoption of DCTs, as traditional clinical trials have been disrupted and the need for remote patient monitoring has increased.

North America is the largest production region, with a share about 60%, followed by Europe and Asia-Pacific, both have a share over 30 percent. In terms of product, Interventional is the largest segment, with a share over 45%. And in terms of application, the largest application is Oncology, followed by Cardiovascular, etc.

The DCTs market is expected to continue to grow as technology improves and more companies enter the market. The growth of the market will be driven by the increasing demand for remote patient monitoring and the growth of the digital health market. Additionally, the increasing demand for more efficient and cost-effective clinical trials is expected to drive the growth of the DCTs market in the future.

What about DCTs in European Union?

The European Commission (EC), the?Heads of Medicines Agencies?(HMA) and the European Medicines Agency (EMA) have published?recommendations?that aim to facilitate the conduct of decentralised?clinical trials(DCTs) while safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected. This is an outcome of their joint initiative to?Accelerate Clinical Trials in the European Union?(ACT EU).

The recommendations include an overview of national provisions for specific decentralised?clinical trial elements to be used in?clinical trials. They were put together by the?European medicines regulatory networkwith experts from regulatory bodies responsible for the authorisation of?clinical trials, members of ethic committees,?good clinical practice?inspectors, methodology experts and representatives of patient organisations. Drafting of the paper was coordinated by the?clinical trials coordination group?(CTCG).

These recommendations under ACT EU are a first and important step towards clarifying the use of decentralised?clinical trials?in the EU/EEA by the?European medicines regulatory network.

They are expected to evolve as knowledge increases and experience is gained. In particular, the overview of national provisions will be updated on a continuous basis. ACT EU features ten priority action areas that are the basis for the?ACT EU 2022-2026 workplan.

How decentralised clinical trials (DCTs) can be used to evaluate digital therapeutics outcomes?

Decentralized Clinical Trials (DCTs) can be used to evaluate the outcomes of digital therapeutics (DTx) by enabling remote patient monitoring and collecting data from patients in their own homes. This can be done through the use of digital devices such as smartphones, tablets, and wearable devices, as well as through the use of cloud-based platforms for data management and analysis.

Here are some key benefits of using DCTs to evaluate digital therapeutics outcomes:

1. Increased patient engagement: DCTs allow patients to participate in clinical trials from the comfort of their own homes, increasing patient engagement and reducing the drop-out rate.
2. Real-world data collection: DCTs collect data from patients in real-world environments, providing a more accurate representation of the effects of digital therapeutics.
3. Cost-effective: DCTs are typically less expensive than traditional clinical trials, as they do not require as many visits to clinical trial sites and do not require as much staff time for monitoring and data collection.
4. Faster trial completion: DCTs can reduce the time required to complete clinical trials, as they allow for remote data collection and analysis.
5. Improved patient safety: DCTs can reduce the risk of adverse events, as patients are monitored in real-time and can quickly report any issues to the trial sponsor.