Benefits and Challenges of Decentralized Clinical Trials

With the emergence of COVID-19, a need to change how clinical trials are executed has driven an industry-wide push toward utilizing a different approach to traditional trials. The adoption of decentralized clinical trials (DCTs) has become a necessity in order to adhere to social distancing requirements while continuing to conduct vital research.

Though pandemic restrictions are being lifted and more clinical sites are allowing participants to return for studies, the numerous benefits of a decentralized approach have made this study model an attractive alternative for future clinical trials. Decentralized solutions can also be attractive to an investigator with specific therapeutic expertise who is looking for a rare and thin patient population.

Differing from traditional clinical research, DCTs employ a more patient-centric approach by minimizing barriers to participation by utilizing different technologies (e.g. sensory-based technologies, wearable medical devices, etc.) and approaches (e.g. telemedicine, home visits, etc.) to recruit and retain participants.

The study design also saves time for patients by reducing travel burden to the clinical site and disruptions in their day-to-day activities [1]. The merits of DCTs are not limited to study participants only. Sponsors also benefit from decentralized trials with reduced costs, less travel time required, enhanced data accuracy, and real-time data monitoring.

Clinical Studies Attrition

Patient recruitment and retention remain a primary hindrance to the success of clinical trials. In 2018, between 50-60 % of studies failed to recruit sufficient numbers of participants leading to less conclusive results and delays in the completion of the studies [2].

After recruitment, retention is also quite poor with many studies experiencing delays related to participant issues. These two factors can have detrimental implications to the validity of studies and could lead to a considerable increase in the cost of trials hence the need for re-designing study approaches and adopting decentralized clinical trial methods either in part or in entirety.

Benefits of Decentralized Trials

More flexible 

Typically in life science research, a traditional clinical trial is designed around the research centers, where members of the clinical operations team monitor the trial data of a local population.

Participants travel to the site to complete visits throughout the study. This process may cause appreciable disruption in their daily activities. DCT, however, employs a patient-centered approach by leveraging virtual tools such as telemedicine and wearable devices to carry out remote visits and monitor data. Therefore, making participation in the study more flexible by allowing such things as submitting data from anywhere and having blood draws performed at home.

The geographical location of a clinical site and the distance to travel there are the most important factors participants consider and can be a huge barrier to deciding to participate in a study [2]. With DCTs, data collection and monitoring are conducted remotely which means the participants do not need to travel long distances to access the site hence decreasing the barriers of participation. Even hybrid trials would alleviate some of the patient burden.

Telemedicine, wearables and drug delivery significantly reduce travel time

Better patient recruitment and retention

DCT has the potential to improve recruitment and retention of each study participant. Out of the clinical trial participants recruited in various studies, a dropout rate of approximately 30 percent[4] is generally observed.

Successful retention involves using mechanisms that keep patients in a study positively engaged and motivated to remain in the trial until completion. The patient experience must be understood and emphasized. When participants perceive a significant patient burden, the likelihood of attrition is higher. Factors like frequent scheduled onsite visits increase dropout rates. Patient centricity in the form of reduced site visits can all be realized without any disruption to trial conduct.

DCTs focus on the trial participant and can relieve such burdens by utilizing telehealth services for remote visits and wearable devices for virtual clinical trial data collection. The trial design must make use of this digital technology while maintaining strict patient safety standards.

Improved data diversity 

A decentralized model increases participation from diverse patient populations

Decentralized clinical trials can decrease geographic barriers to studies for participants of diverse populations including the elderly, those living in remote areas, or ethnic minorities who are currently underrepresented in traditional onsite designs[3]. Clinical trial sponsors should see a richer patient population and accompanying patient data.

By reducing these barriers to clinical trial participation, a more diverse set of data can be collected simulating a real-world setting which can increase the external validity of the clinical trial[4].

Real-time communication with patients

Effective communication between the participant and the study site personnel is essential in any clinical trial as it helps keep the participants motivated and enhances retention. DCTs can employ ePRO (electronic patient reporting outcome) tools to maintain real-time communication with the participants. These tools allow participants to report symptoms and other data as soon as they occur thereby minimizing the incidence of missed data points or safety issues. 

Additionally, the utilization of telemedicine makes it easier for participants to interact with study personnel at their own convenience. Also, eReminders can be employed to help participants remember to submit important data consistently and in real-time.

Telemedicine allows real-time communication between caregivers, clinicians and study participants

Challenges of Decentralized Trials

 Data systems

Since a decentralized approach involves multiple collection and data storage locations, increased security is required. A guiding principle must be that in any virtual trial, data quality along with data security.

A decentralized trial primarily involves the electronic submission of participant data which comes with an additional need for cybersecurity to ensure compliance with data protection regulations.

Conventionally, firewalled and centrally controlled local data systems are used in storing participant information[5].

In many decentralized studies, participants will interact with several involving local healthcare providers via different In many decentralized studies, participants will interact with several involving local healthcare providers via different electronic health record (EHR) systems which can cause a challenge especially in amalgamating data since many EHR systems do not talk with each other[5].

Drug distribution and management

Ease of distribution and drug management is one main advantage that traditional trials have over decentralized trials. In traditional trials, drugs are transported and stored at a central research site where their storage and stability requirements can be met[5].

However, with DCTs, the drug needs to be shipped to the individual participant’s home l which can present many challenges. These challenges can include an increase in costs, lack of a guarantee that stability and storage requirements will be maintained, prevention of unauthorized access, detection of drug tampering, a method of recording dosing administration, and interruptions of the study due to drug refills not being received on time[5].

Additionally, it should be noted, that drug dispensing regulations can vary from one locality to another which can complicate a DCT study further[5]. The study team must be vigilant in their understanding of local requirements.

A Direct-to-Patient (DTP) model allows for drug therapies to be delivered to the patient’s home

Use of technology

Decentralized trials leverage modern technology to deliver clinical study results however, technology utilization also poses a major challenge to protocol compliance.

For instance, wearable devices used in the collection of participant information are still in the initial stages of development and have not been widely embraced[5].

The majority of these biometric devices still require validation by the clinical trial operations team to meet regulatory standards before their widespread use is approved[5].

Furthermore, utilization of technological devices depends on the availability of technical support for troubleshooting issues, various transmission methods, physical parts such as batteries, and intranet infrastructure that the participant can access. All of these things can pose a challenge to a DCT trial[5].

  1. Van Norman G. A. (2021). Decentralized Clinical Trials: The Future of Medical Product Development?∗. JACC. Basic to translational science, 6(4), 384–387. 
  2. Sommer, C., Zuccolin, D., Arnera, V., Schmitz, N., Adolfsson, P., Colombo, N., Gilg, R., & McDowell, B. (2018). Building clinical trials around patients: Evaluation and comparison of decentralized and conventional site models in patients with low back pain. Contemporary clinical trials communications, 11, 120–126. 
  3. Van Norman G. A. (2021). Decentralized Clinical Trials: The Future of Medical Product Development?∗. JACC. Basic to translational science, 6(4), 384–387. 
  4. Khozin, S.,& Coravos, A. (2019). Decentralized Trials in the Age of Real-World Evidence and Inclusivity in Clinical Investigations. Clinical Pharmacology & Therapeutics, 0(0), 1-3. 
  5. Van Norman G. A. (2021). Decentralized Clinical Trials: The Future of Medical Product Development?∗. JACC. Basic to translational science, 6(4), 384–387.