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Dec 04, 2023

InsightAce Analytic | Clinical Trials , virtual clinical trials , remote clinical trials ,

What is decentralized clinical trials

Conventional clinical trials, also known as in-person or on-site clinical trials, are clinical research studies that are conducted in a traditional setting, such as a hospital or research clinic. Participants in these trials are typically required to visit the study site in order to receive treatment and participate in study-related activities.

 

Decentralized clinical trials, on the other hand, are clinical research studies that are conducted using technology to facilitate remote data collection and communication between study participants and researchers. Participants in these trials are typically able to participate from the comfort of their own homes, rather than requiring them to travel to a clinical trial site. 

 

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What are the potential issue with clinical trials those are solved by decentralized clinical trials?

Before the COVID-19 pandemic, decentralized clinical trials (also known as remote or virtual clinical trials) were not widely used. However, the pandemic has led to an increase in the use of virtualization in clinical trials and in other contexts. Apart from COVID-19, there are several factors that are contributing to the increasing adoption of decentralized clinical trials:

 

  • Increased accessibility: Decentralized clinical trials can increase the accessibility of clinical research to people who may not be able to participate in traditional, in-person clinical trials due to distance, mobility issues, or other logistical barriers. For instance, on average, about 70% of potential clinical trial participants live more than two hours away from the trial site. This can potentially increase the diversity of the study population and enhance the generalizability of the study findings.
  • Reduced cost: Decentralized clinical trials can reduce the cost of clinical research by eliminating the need for in-person visits and can potentially increase the speed of research by reducing the time it takes to enroll and follow up with study participants.
  • Improved patient adherence: Decentralized clinical trials may be able to improve patient adherence to the study protocol, as participants can receive treatment and complete study-related activities from the comfort of their own homes and may be more likely to adhere to the study protocol as a result.
  • Enhanced data collection: Decentralized clinical trials can use a combination of online communication platforms, mobile apps, and wearable devices to collect data remotely, which can potentially enhance the accuracy and completeness of the data collected.
  • Reduced burden on study participants: Decentralized clinical trials can reduce the burden on study participants, as they do not need to travel to a clinical trial site and can participate in the study from the comfort of their own homes.

 

However, it is important to note that decentralized clinical trials are not a replacement for in-person clinical trials and may not be suitable for all research questions or study populations. It is important to carefully consider the specific research question and study population when deciding whether to conduct a decentralized clinical trial.

 

Acceptance to decentralized clinical trial by patient, by HCP, by regulatory authorities:

Due to all its benefits or advantages, decentralized clinical trials are being welcomed by all stakeholders. For instance, number of decentralized clinical trials almost doubled in 2022 as compare to 2020 and reached ~1300. Further, one survey found that 72% of physicians felt that their experiences with remote engagement were similar to or better than in-person visits.

Many patients have reported high levels of satisfaction with the shift to virtual care and communication. A recent global survey of oncology, cardiology, and immunology patients in the US, UK, China, France, Germany, and Japan found that 90% of respondents felt that the quality of care was as good or better than before the pandemic, and 60% indicated that they wanted to continue using technology in the future for managing their conditions and communicating with their healthcare providers. The survey also found that patients had adopted virtual care and communication at high rates.


Major trends in decentralized clinical trials

Following are the major trends observed in decentralized clinical trials:

 

1.      COVID-19 has boosted the Adoption of Decentralized Clinical Trials

During the COVID-19 pandemic, many clinical trials experienced decreased enrollment or were halted due to difficulties in maintaining patient visits, delays in trial activities, and difficulties in following protocols. This situation led to the rapid adoption of virtual methods in many trials, allowing them to continue and demonstrating the industry's ability to quickly adapt to the new environment. A survey of clinical trial investigators and coordinators found that the percentage of participant interactions conducted remotely increased from 9% to 57% between January and May 2020. A survey by the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the FDA and Duke University, found that 85% of respondents transitioned to remote/virtual visits in one or more ongoing trials during the pandemic. Prior to the pandemic, a survey conducted by Industry Standard Research found that 38% of biopharmaceuticals and CROs expected decentralized trials to be a major component of their trial portfolios, and 48% expected to conduct a trial with most activities done in patients' homes. A year later, McKinsey found that these figures had increased to 100% and 89%, respectively.

 

2.     Use of technology rising continuously:

One of the main drivers of the trend towards decentralized clinical trials is the increasing availability and use of technology/software such as electronic consent, telehealthcare, remote patient monitoring, and electronic clinical-outcome assessments (eCOAs). These technologies have allowed for clinical trial activities to be more closely centered around patients, without the need for in-person visits. Mobile and home healthcare, as well as alternative care locations, have also enabled more procedures to be performed outside of traditional research sites. These developments have facilitated the maintenance of connections between investigators and trial participants.

More details on technology/software mentioned above:

  • Electronic data capture (EDC) systems: These systems are being used for collecting, storing, and managing data from study participants, such as patient information, medical history, and study outcomes. EDC systems can be accessed by researchers and study participants remotely, allowing for real-time data collection and analysis.
  • Telemedicine platforms: These platforms allowing remote consultations between study participants and healthcare professionals, using video or audio calls. It is also being used to collect the data on patient’s health status and intervene if necessary.
  • Clinical trial management systems (CTMS): These systems are allowing clinicians to oversee and manage the various aspects of a clinical trial, such as recruitment, data collection, and regulatory compliance. CTMS can be accessed remotely by study staff, allowing for real-time coordination of trial activities.
  • Mobile apps: Mobile apps being used to collect data from study participants, such as health metrics (e.g. blood pressure, blood glucose levels) and patient-reported outcomes. Apps are also being used to communicate with study participants and provide them with information about the trial.
  • Wearables: Wearable devices, such as smartwatches and fitness trackers, are being used to collect data on a participant's physical activity, sleep patterns, and other health metrics.

Overall, the use of software in decentralized clinical trials allows for more efficient and convenient data collection, as well as improved communication and coordination between study participants and researchers. This has led to a proliferation of virtual trial platforms and services that support the conduct of decentralized trials, including patient recruitment, data collection, and remote monitoring.

 

3.      Growing support from regulatory authorities:

Regulatory agencies around the world have recognized the increasing role of digital technologies in clinical trials, and have taken steps to adapt and provide guidance for the safe and compliant conduct of decentralized clinical trials (DCTs). The US Food and Drug Administration (FDA) has highlighted the benefits of DCTs, including increased efficiency and cost savings, faster enrollment and increased diversity, more frequent measurements, and reduced burdens for patients. In response to the COVID-19 pandemic, the FDA and other regulatory agencies including the European Medicines Agency (EMA) and the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) have issued guidance documents on how to implement new processes and methods to protect patients and maintain Good Clinical Practice (GCP) standards while conducting DCTs. These documents cover a range of topics including the use of digital health technologies for remote site monitoring, informed consent, remote trial visits, and data integrity.

 

The FDA has also initiated various programs and initiatives to advance the use of digital technologies in clinical trials. These include the Patient-Focused Drug Development program, which aims to inform the development and use of methods to gather and submit patient experience data, and the CTTI Mobile Clinical Trials program, which aims to influence the widespread adoption of mobile technology in clinical trials. The European Commission has also published a legal framework to provide guidance on EU legislation to app developers, medical device manufacturers, and digital distribution platforms.

In Asia-Pacific countries, the adoption of mobile health technologies has been high, and several countries have implemented regulatory sandboxes to bring together the views of healthcare professionals and businesses to support innovation. The World Health Organization (WHO) has also identified the Eastern Mediterranean, Western Pacific, and South-East Asia Regions as having the highest percentage of countries evaluating government-sponsored mobile health programs. In addition to providing guidance and support for the use of digital technologies in clinical trials, regulatory agencies are also increasingly using digital technologies to streamline their own processes, including the submission and review of clinical trial applications.

 

Who are the major players in decentralized clinical trials

 

Johnson & Johnson, Pfizer, Novartis, Roche, AstraZeneca, Merck, Sanofi, GlaxoSmithKline, Eli Lilly, AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Celgene, and Gilead Sciences, etc. Are some of the major companies using decentralized clinical trials. While, Parexel, ICON, Syneos Health, PRA Health Sciences, QuintilesIMS, Covance, Medidata, BioClinica, eClinical Solutions, Clinical Ink, ERT, Medpace, CRF Health, inVentiv Health, and Envigo etc. are the companies offering related services.

 

How decentralized clinical trials will change clinical trial in future

 

Decentralized clinical trials are expected to continue to gain significant attention in the future as a trend in clinical research. These types of trials will be conducted remotely through the use of technology such as telemedicine, wearable devices, and electronic data capture, allowing for a wider pool of participants to participate in clinical trials regardless of their location or physical ability to travel to a trial site.

There will be the increasing demand for more convenient and patient-centered research. Many patients, especially those with chronic conditions, will face barriers to participation in traditional clinical trials due to their geographic location or physical limitations. Decentralized clinical trials will allow these patients to participate in research from the comfort of their own home, which can significantly improve patient retention and satisfaction.

There will be the further increase in adoption of digital health technologies. Wearable devices and telemedicine technologies will become increasingly sophisticated and will be able to accurately measure and collect a wide range of data points, including vital signs, physical activity, and sleep patterns. This data will be used to assess the efficacy of new treatments and drugs, making it an attractive option for trial sponsors.

 

However, there will also be challenges to decentralized clinical trials that must be addressed in order for them to become a mainstream option for clinical research. One challenge will be the need for strong regulatory frameworks to ensure the quality and integrity of the data collected in these trials. Another challenge will be the need to ensure that participants have access to the technology and support needed to participate in a decentralized trial. Finally, there will be a need to address potential ethical concerns related to the use of electronic data capture in clinical research.

Overall, decentralized clinical trials have the potential to greatly improve the clinical trial process and increase access to clinical research for patients. While there are challenges to overcome, it is likely that decentralized clinical trials will continue to grow in popularity in the future as technology advances and the demand for more patient-centered research increases.

Tags : Clinical Trials virtual clinical trials remote clinical trials