The Trials@Home course on DCTs

CHAPTER 1: Why do decentralised clinical trials?

Decentralised clinical trials (DCTs) are a way of conducting research that allows participants to participate from the comfort of their own homes, rather than having to travel to a clinic or hospital.

Here are some potential benefits for participants and trial sites when conducting DCTs:

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In traditional clinical trials, participants often need to travel (long distances) to take part, as the trial will not necessarily be at the hospital or practice closest to the participant. This can be time-consuming and costly for the participant as they, for example, need to take time off from work and lose income. Taking part in a trial may include many visits to the hospital for blood tests and other examinations. Facilitating these tests at the participants home could better fit in with the participant’s lifestyle meaning less effect on work or childcare, and thus reducing participant burden. Where certain assessments need to be conducted in a study centre, a hybrid approach can be taken to incorporate both remote (decentralised) and site-based elements, increasing flexibility.

Making trials more convenient and accessible for participants, may make them more likely to complete the study, which leads to better data in the trial.

Decentralised trials make it easier for participants who live in rural, far away or underserved areas to join studies. This may help ensure that more diverse participant populations are included. This is very important when testing new therapies, to improve the relevance of the trial results for a broader range of people. It also makes it accessible for people who have less time to commit (as there is more flexibility to fit the trial activities into their daily lives), or for those with reduced mobility, for example.

DCTs often use technology, like wearable devices, smartphones or mobile apps and telemedicine appointments to collect data in real-time, to potentially allow more robust monitoring and support of clinical trial participants and management of such trials in general. It means doctors can track participants’ progress continuously, without waiting for scheduled visits at the study center, which can lead to better care and faster adjustments to treatment plans, if needed. In addition, data collected in DCTs are expected to be more representative of the real world.

Since participants don’t need to go to a hospital or clinic, they can feel more comfortable. Talking to a doctor from home can make it easier for participants to be open about their health, which is essential for accurate results. It can also make it easier to involve other members of the family into decision making, such as the consenting process, if the participant wants that.

Decentralised trials have the potential to enrol participants faster because they can reach a larger and more diverse group of people. This can help speed up the entire research process, bringing new treatments to market for participants more quickly. This may be of particular importance in rare disease trials, where numbers of participants are low and spread over large geographical areas, so conventional trial centres may not recruit enough participants.

Because DCTs can cut down on the need for physical locations, travel, and hospital visits, they can potentially be less expensive for both participants and researchers. This could also help make clinical trials more accessible for people who may not have funds to pay in advance for travel or cannot afford to miss work to participate in traditional studies.

DCTs can offer greater flexibility in special circumstances, like the recent COVID-19 pandemic, to ensure that trials can still continue and participants get access to these trial medications. This could also apply to other similar situations where travel is limited or if people are immunocompromised and want/need to isolate to limit exposure.

In conclusion, DCTs can potentially help improve the experience for participants and ensure that new treatments are tested in a way that is more inclusive, accessible, and participant-friendly.

Quiz

Question 1:

Which of the following are potential benefits of decentralised clinical trials for participants?

(Select the answers you think are true)

Correct!

Incorrect!

Decentralised trials reduce the need for frequent in-person visits.

Correct!

Incorrect!

Costs are generally lower for participants since travel expenses paid in advance and time off work are minimised.

Question 2:

Which of the following are potential benefits of decentralised clinical trials for study centres?

(Select the answers you think are true)

Correct!

Incorrect!

DCTs can potentially reduce operational burden by minimising in-person visits and automating data collection, but given this isn’t proven, it might also increase the operational burden.

Correct!

Correct!

Incorrect!

DCTs may improve compliance through real-time monitoring.

Correct!

CHAPTER 2: Know the most common DCT elements

References

  1. What are digital literacy requirements for Decentralised Clinical Trials? A Delphi study to reach expert consensus. Parla Işıl Yüksel, Bart Lagerwaard, Mira Zuidgeest, on behalf of Trials@Home
  2. Cox, M. A., & Barnett, A. (2020). “Decentralized Clinical Trials: A New Era for Clinical Research.” Journal of Clinical Trials.
    This paper discusses how decentralized trials offer a way to streamline patient recruitment, enhance data collection, and lower costs.
  3. Gibson, C., & Wilkins, J. (2021). “How Decentralized Clinical Trials Can Improve Patient Access and Compliance.” Journal of Digital Health.
    This article highlights how digital technologies used in DCTs can offer real-time monitoring and increase patient compliance.
  4. Kenny, P. T., & Martin, C. (2019). “Patient-Centered Approaches in Decentralized Clinical Trials.” The Lancet Digital Health.
    This study explores how decentralized clinical trials create a more patient-centered experience, improving retention rates and data accuracy.