The Trials@Home course on DCTs

Introduction

The IMI Trials@Home consortium has developed this training for patients and patient organisations.

Nowadays, it is possible to participate in a clinical trial from the comfort of your home instead of visiting your doctor regularly, and such trials are called Decentralised Clinical Trials (DCTs) or trials with decentralised elements. These trials with decentralised elements are especially important to patients who live with rare diseases or in remote areas. For trials to provide answers on how well treatments work, a certain number of people need to participate in the trial. DCTs provide a unique opportunity for (rare disease) patients to access clinical trials and research. DCTs can also solve logistical and recruitment problems, increase retention and provide a viable option for clinical trials (CT) in Rare Diseases.

Trials@Home aimed to reshape clinical trial design, conduct and operations, by developing recommendations on DCTs in Europe. To optimise implementation of DCTs in Europe, this online training has been created to introduce the concept of DCTs, and to explain how to design and run such trials and which types of technologies can be used.

This course has the following five learning objectives:

  1. Why do decentralised trials?
  2. Know the most common DCT elements
  3. Challenges and expectations in DCTs
  4. Co-creating DCTs – engaging with the target participant group to design the study tailored to the potential participant
  5. RADIAL, the Trials@Home proof-of-concept study, as an example of a DCT

After taking this course, you will be familiar with DCT approaches. This course also covers the possibilities and advantages of patient involvement through co-creation of the DCT protocol and recruitment methods, so that such trials can be successfully completed and benefit all involved in drug development, including patients.

What is Trials@Home?

What are clinical trials?

Clinical trials are research studies in which people volunteer to receive medical interventions including medicines, cells or other biological products, surgical or radiological procedures, devices, behavioural treatments, or preventive care, to help answer specific research questions according to a protocol provided by the trial sponsor. More details about clinical trials are provided here on the project website.

Why are clinical trials important?

  • The goal of clinical trials is to determine if a new treatment works and is safe.
  • If the product successfully completes Phases I, II, and III, something which usually takes on average 10 years to complete, and is shown to be safe and effective, it will be approved by regulatory authorities to be marketed and used.

In a survey from 2018 among 1,602 residents from Ontario and British Columbia, benefits of clinical trials were identified. The survey questioned them on their understanding of and willingness to participate in clinical trials. Survey results are displayed in the figure below.

It is acknowledged that patients participate in clinical trials for a variety of reasons and the list above is an example of benefits, which can differ from person to person or even per trial.

What are DCTs?

As described by the Trials@Home consortium, DCTs are clinical trials in which some or all trial activities take place at the participant’s home or other local setting. This approach can make use of technologies and other innovative operational approaches and minimises or eliminates physical visits to a clinical trial centre, thereby making the trial more accessible to participants.

European regulators mentioned in their Recommendation Paper on decentralised elements in clinical trials, released in December 2022, that “Clinical trials on Investigational Medicinal Products (IMPs) are increasingly using procedures conducted outside the traditional ‘clinical trial site’, a concept usually referred to as decentralisation. In addition, there is increasing use of digital tools within clinical trials”. In this recommendation paper (RP), regulators address all stakeholders’ roles and responsibilities, electronic informed consent, study medication delivery, trial related procedures at home, data management and monitoring in a DCT setting. An overview of the current national provisions applicable in each European Member State in relation to these topics is outlined in the appendix of this RP. Given the rapid advances in the field of DCT, the paper is expected to evolve when new insights and experiences are gained.

The term decentralised trial includes hybrid trials that use only some remote approaches in combination with more conventional study centre-based approaches as well as fully decentralised or fully remote trials where there may be no direct interaction between trial personnel and participants.  

More details on DCTs can be found in this video.

What are DCTs?

What are the potential benefits of DCTs?

  1. Convenience and Flexibility, reduced participant burden
  2. Increased diversity and improved Access to trial participation
  3. Better Monitoring and Real-Time Feedback
  4. Increased Patient Privacy and Comfort
  5. Faster Recruitment, Enrolment and Improved Retention
  6. Reduced Costs

Quiz

When participating in a fully decentralised trial, the patient will never meet a doctor in person.

True or False?

Correct!

  • This is true with a full DCT, since in person meetings are completely eliminated. Participants will only interact with the study team via digital methods such as videoconferencing
  • However, in the case of a hybrid DCT where only some clinical trial activities take place in the participant’s home and/or local clinical settings, in-person visits to a clinical trial centre (i.e., an hospital or a clinic) can still take place.
  • Conventional clinical trials rely on in-person interactions between the trial team and the trial participant by means of visits to a clinical trial centre.
  • DCTs make use of digital health tools (e.g. wearables, accelerometers, electronic questionnaire), and/or other innovative new methods (e.g., remote consent, telemedicine) to make them more accessible to participants.

Incorrect!

  • This is true with a full DCT, since in person meetings are completely eliminated. Participants will only interact with the study team via digital methods such as videoconferencing
  • However, in the case of a hybrid DCT where only some clinical trial activities take place in the participant’s home and/or local clinical settings, in-person visits to a clinical trial centre (i.e., an hospital or a clinic) can still take place.
  • Conventional clinical trials rely on in-person interactions between the trial team and the trial participant by means of visits to a clinical trial centre.
  • DCTs make use of digital health tools (e.g. wearables, accelerometers, electronic questionnaire), and/or other innovative new methods (e.g., remote consent, telemedicine) to make them more accessible to participants.
CHAPTER 1: Why do decentralised clinical trials?

References

  1. https://www.researchgate.net/publication/328605572_Survey_of_Awareness_and_Perceptions_of_Canadians_on_the_Benefits_and_Risks_of_Clinical_Trials
  2. https://trialsathome.com/glossary/decentralised-clinical-trial
  3. https://health.ec.europa.eu/system/files/2023-03/mp_decentralised-elements_clinical-trials_rec_en.pdf