Activities & Operations

Best practices for DCT approaches

Many of the best practices for DCTs are the same as in more conventional trial designs. However, some areas of DCT design and planning need additional attention to make the trial successful and to improve the participant experience.

Recommendations

All clinical trials should aim to answer important questions that help patients and healthcare professionals make informed decisions in the future.

Researchers should always consider the safety, needs, and preferences of the people taking part in a trial.

Researchers should make it as simple as possible to take part in a trial without compromising the ability of the trial to answer the research question.

Everyone involved in making a trial happen, from healthcare professionals and patient groups to those responsible for approving trials and new medicines, should be involved in discussions about the trial plans early, so that their opinions and advice can be taken into account.

Some DCT approaches are still relatively new, and we can learn how to use them more effectively if we share our experiences, challenges, and solutions.

We should use scientific methods to learn more about when and how DCT approaches work best so that we can improve trials in the future.

It is not just participants who benefit from simpler trials; the staff who work on trials can do their jobs better when trials are designed with them in mind.

DCTs can be complicated and involve many technological and organisational aspects. All aspects, both technical and logistical, must be tested to check that they work before the trial starts.

In addition to providing participants with information in a way they can understand, researchers should also make it easy for participants to communicate with trial staff and access support during the trial, so that they feel confident in carrying out trial activities at home.

DCT approaches can involve many different people, and they need to work well together. It is worthwhile to take the time to build trust among those involved in different aspects of the trial.

Clear communication becomes even more important when there is less in-person contact. Careful planning of communication methods and timing can make things run more smoothly, both for routine trial activities and when unexpected events occur.

Everyone involved in a DCT has a role, from participants remembering to complete questionnaires to the person responsible for ensuring that blood samples arrive in the laboratory on time. Knowing who is responsible for what and when ensures that tasks are not overlooked and that participants are kept safe.

DCT approaches are still new to many healthcare professionals. Anyone planning a DCT needs to ensure that all the staff working on it will be appropriately trained and supported for any new ways of working.

No matter how well-designed a DCT is, external events like changes to laws and regulations, problems with delivering trial materials, or even global pandemics should be prepared for.

Some people have suggested that DCTs should be less expensive than conventional clinical trials because they require fewer staff and fewer clinic sites. However, our research shows that DCTs may still need a lot of resources to ensure that everything works, that medications and trial materials are where they need to be at the right time, and that everyone involved has the training and support they need.

How Trials@Home reached these recommendations

We identified the best practices in the field of DCT approaches through systematic review of the literature on methods used in DCTs, identification of key case studies that illustrated challenges and solutions in DCT and interviews with stakeholders involved in DCT. We identified many good practices, yet we also encountered many challenges in areas particular to DCTs. The solutions employed for these challenges can inform future best practices.

Further reading

Publications

Learning from Remote Decentralised Clinical Trial (RDCT) experiences: a qualitative analysis of interviews with trial personnel, patient representatives and other stakeholders.

Coyle, et al
British Journal of Clinical Pharmacology
2021
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Read the layman version
View poster version

A Systematic Review of Methods used to Conduct Decentralised Clinical Trials

Rogers, et al
British Journal of Clinical Pharmacology
2021
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View poster version

A secondary qualitative analysis of stakeholder views about participant recruitment, retention, and adherence in decentralised clinical trials (DCTs)

Coyle, et al
Trials
2022
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Deliverables

First set of recommendations for DCTs (to be implemented in the pan-EU pilot DCT.)

WP BEST, 2020
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Criteria for selection of appropriate trials

WP BEST, 2020
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Update of recommendations based on ongoing case studies running in parallel to the WP3 pilot

WP BEST, 2025
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