The Trials@Home DCT course

CHAPTER 4: Co-creating DCTs – engaging with the target participant group to design the study tailored to the potential participant

Many stakeholders are involved in the design and conduct of clinical trials, including (but not limited to) researchers, regulators, funding bodies, patient organisations and patients. This last group has gained more of a voice in recent years as researchers and sponsors began to understand that the involvement of lived experience led to more meaningful trial goals, designs and outcomes.

Co-creating clinical trials with people with lived experience helps researchers understand what does and does not work for people in their daily lives across representative population groups and ensure that the research questions and goals are meaningful, since there is often a gap between the idea of a trial and the real-world reality of it. Co-creation can occur during clinical trial design as well as during the intervention and when the trial has finished through, for example, communication and dissemination of results.

More on that in this video from The Lancet with statements from Trials@Home:

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The complexity of Decentralised Clinical Trials (DCTs) – e.g., the need for increased personal involvement by participants, the different ways for communication, the use of technology and other tools and the potential of home visits by home nurses – makes it even more important to ensure that all practicalities, views and perspectives are understood and taken into consideration from the design stage onwards.

What are the main benefits of co-creation with patients?

There are many benefits to engaging with people with lived experience, and they are often interlinked. Ensuring the needs and preferences of people are taken into account in the trial design not only improves the patient-centricity of the trials, but it also fosters trust and transparency, both of which can also help with improved retention and (more diverse) recruitment. Linked to this, more patient-centricity can contribute to better technology usability and data quality.

Click to expand to learn more about benefits of co-creation.

When DCTs are being designed for a specific group of people, data can only give you so much of the story. People living with a condition can enrich the trial design with their real-world experiences. They can help the designers behind DCTs understand whether aspects of the trial are realistic, doable, and can fit into their daily lives. This helps make trials less burdensome, more user-friendly, and accessible. Empowerment of people with lived experience also fosters a collaborative approach to research which ultimately leads to better scientific results and improved participant experiences.

Knowing that patients helped design the trial may help potential and actual participants trust the process and results. People who co-created the trial can also advocate for clear communication of risks, benefits, and expectations, ensuring full transparency. In the case of rare diseases where the number of people living with those conditions is already small, rare diseases networks can be used to spread the word about the trial and find more participants for the trial.

Clinical trials can be demanding. This means that they sometimes have high dropout rates. This is a major challenge to gather enough quality data, especially if the number of people participating in the trial is already small. Improving the patient-centricity of a DCT design means that issues that might come up later and cause participants to drop out might be identified early. For example, if a DCT for a childhood disease is designed with mid-morning virtual appointments, parents and children can help point out to the trial designers that the children might not be available at the required time due to being at school. This is one very simple example, but it is a useful one in understanding how people can help DCT designers identify issues, eliminate them and ensure that participants are on board all the way to the end of the trial.

Another aspect of the involvement of patients in clinical trial design and conduct is for them to help design recruitment material such as leaflets and websites, thereby also potentially enhancing the recruitment and retention.

One of the potentially strongest benefits of DCTs is that they are able to reach more people and more diverse patient populations compared to conventional clinical trials .

As well as enhancing recruitment generally, co-creating DCTs with patients helps identify barriers that may specifically affect underserved patient groups or people that do not typically participate in trials. This may include barriers relating to location, language, or cultural concerns. Consider the following example: thalassemia is an inherited blood condition that in the UK occurs more frequently in minority populations such as those from South Asia. Such patients may have certain cultural and religious beliefs which need to be considered when designing a DCT. In this case, if a appointment is required, participants may feel more at ease with someone who is aware of their cultural background. This is a consideration that patients can help identify at the design stage to avoid participants dropping out due to their discomfort during the process.

DCTs often rely on digital tools and technologies, which include apps, wearables, virtual appointments, and more. These technologies may be unfamiliar or difficult to use for some groups of people. Patients can test and provide feedback on these tools to improve their usability and accessibility for diverse populations, thus improving the design of the trials.
Researchers may overlook practical barriers, such as difficulties in using wearables or devices, the burden of frequent data reporting, or the need for technical support. Patients can help identify these issues before the trial starts, improving overall efficiency.

With patients helping design the DCT, the resulting DCT is likely to be more user-friendly. This might mean that participants will be more engaged with the trial and possibly more likely to provide accurate, consistent, and complete data. Their input may help to ensure that the collected data reflects real-world health outcomes.

Quiz

Question 1:

Which of the following answers are true/false?

(Select the answers you think are true)

Question 2:

Early involvement of patients can help identify how realistic the demands of the trial are to avoid dropouts at a later stage

True or false?

Correct!

Incorrect!

People living with a condition can enrich the trial design with their real-world experiences.

Question 3:

Patients involved in DCT design can help identify which digital tools will be best suited for the potential participant in question.

True or false?

Correct!

Incorrect!

Question 4:

Researchers alone are the best people to determine whether the digital tools used in a DCT are accessible and easy to use.

True or false?

Incorrect!

Correct!

Chapter 5: RADIAL, the Trials@Home proof-of-concept trial

References

  1. Kopanz J, Lagerwaard B, Beran M, et al. What motivates people with type 2 diabetes mellitus to participate in clinical trials from home? Clin Transl Sci. 2024; 17:e70070. doi:10.1111/cts.70070
  2. Coyle J, Rogers A, Copland R, et al. Learning from remote decentralised clinical trial experiences: A qualitative analysis of interviews with trial personnel, patient representatives and other stakeholders. Br J Clin Pharmacol. 2022; 88(3): 1031-1042. https://doi.org/10.1111/bcp.15003
  3. Amos J. de Jong, Mira G.P. Zuidgeest, Yared Santa-Ana-Tellez, et al
    The impact of operational trial approaches on representativeness: Comparison of decentralized clinical trial participants, conventional trial participants, and patients in daily practice,
    https://doi.org/10.1016/j.drudis.2025.104304.