Fully decentralized clinical trials (DCTs) are a type of clinical trial that uses digital technologies to allow patients to participate in studies from places other than traditional trial sites, which are convenient for trial participants.

DCTs have the potential to advance patient-centric research by making it easier for patients to participate in clinical trials, increasing patient engagement, providing a better patient experience, and producing more realistic results.

 

Development and growth factors for DCTs in 2023:

Decentralized clinical trials are rapidly growing, and several factors drive their development and growth in 2023.

The Availability and Usage of EHRs: Electronic Health Records (EHRs) are real-time, patient-centered records that make information available instantly and securely to authorized users. EHRs can collect data on patients’ medical histories, medications, and lab results, which help to assess patients’ eligibility for trials and to monitor their progress during DCTs.

Artificial intelligence (AI): AI analyzes data from DCTs, identifies patterns and trends, and predicts patient outcomes. AI can help researchers to design more effective trials and to improve the safety and efficacy of new treatments. Check out the article “Artificial Intelligence Contributing to the Functioning of CROs”.

Remote patient monitoring (RPM): RPM is being used to monitor patients’ vital signs, activity levels, and medication adherence in DCTs. This data can be used to identify potential problems early on and to intervene as needed.

Telehealth: Telehealth is used to conduct clinical visits, provide education and support to patients, and collect data on patient outcomes. This makes it possible for patients to participate in decentralized clinical trials from the comfort of their own homes.

Wearable Devices: Wearable devices can collect data on patients’ vital signs and other health metrics, which monitor patients remotely.

 

What are the Benefits of Decentralized Clinical Trials?

This type of trial offers a number of benefits over traditional clinical trials, which are conducted at clinical trial sites.

Increased patient access: DCTs can make it easier for patients to participate in clinical trials, as they do not have to travel to a clinical trial site. This can be especially beneficial for patients who have difficulty traveling.

Reduced costs: DCTs can reduce the costs of clinical trials, as they do not require clinical trial sites. This can make it easier for sponsors to conduct clinical trials and make them more affordable for patients.

Enhanced data quality: DCTs can improve the quality of data collected in clinical trials, as patients are more likely to complete surveys and other data collection activities from home, leading to more accurate and reliable results.

Increased flexibility: DCTs can be more flexible than traditional clinical trials, as they can be tailored to the needs of patients and sponsors. This can make conducting clinical trials for rare diseases or patients with complex medical conditions easier.

 

Challenges with Decentralized Clinical Trials:

Decentralized clinical trials present several challenges that must be addressed for successful implementation.

Data Security and Privacy: Collecting and storing sensitive patient data in decentralized settings requires robust security measures to protect patient privacy. Ensuring compliance with data protection regulations, such as the General Data Protection Regulation (GDPR), is crucial.

Regulatory and Ethical Considerations: DCTs may raise unique regulatory and ethical challenges, including obtaining informed consent remotely and ensuring study conduct oversight and monitoring.

Patient challenges: Some patients may not be comfortable participating in a DCT, as they may prefer to receive care at a clinical trial site. Additionally, some patients may lack the necessary technology, devices, or skills to participate in a DCT.

 

What is the impact of regulatory agencies on Decentralized Clinical Trials?

Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have recognized the potential of decentralized clinical trials and have taken steps to support their implementation.

First, on May 2, 2023, the FDA released a draft guidance that provides recommendations for sponsors, investigators, and stakeholders involved in DCTs. The FDA’s draft guidance covers various aspects of DCTs, including design considerations, remote clinical trial visits, digital health technologies, roles, responsibilities, informed consent, safety monitoring, and more. The FDA’s commitment to discussing decentralized elements with sponsors demonstrates their recognition of the importance of DCTs in addressing public health needs.

In collaboration with the European Commission and the Heads of Medicines Agencies (HMA), the EMA aims to facilitate the conduct of DCTs while ensuring the rights and well-being of participants and the reliability of the collected data. The EMA’s recommendations provide an overview of national provisions for specific DCT elements and involve experts from regulatory bodies, ethic committees, patient organizations, and other stakeholders. These recommendations mark an important step towards clarifying the use of DCTs in the European Union, with ongoing updates and evolution expected as knowledge and experience in this field grow.

 

Summary:

In conclusion, decentralized clinical trials (DCTs) have emerged as a promising approach to revolutionizing the traditional clinical trial model. By leveraging digital technologies and patient-centric approaches, DCTs offer numerous benefits, such as increased patient access, reduced costs, enhanced data quality, and increased flexibility. However, implementing DCTs has challenges, including data security, regulatory compliance, and patient acceptance. Regulatory agencies like the FDA and EMA have recognized the potential of DCTs and have taken steps to support their implementation through draft guidance and recommendations. The continued development and adoption of DCTs are promising for advancing patient-centric research and improving the clinical trial process.