The Trials@Home DCT course

CHAPTER 3: Tackling challenges in DCTs

DCTs have many potential benefits when it comes to bringing clinical trials closer to the patient’s home, but this also means that there are potential challenges that can be encountered along the way.

This chapter covers some of those challenges and how they can be anticipated and managed.

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Some challenges DCTs participants might encounter include:

  • Although being in the comfort of your home, finding privacy and a quiet place might be an issue to perform study procedures
  • Feeling overwhelmed by the technology or technology not working properly
  • Confusion around the required study activities
  • Different ways of interacting with staff due to the decentralised nature of the trial
  • Unrealistic expectations about doing the trial at home, it might not be as easy as imagined.

Most of these challenges can be countered by making sure that participants feel fully supported in due time, receive clearly worded communication that is easy to respond to and have clear points of contact to raise their questions.

Some studies have shown that participants feel more comfortable using their own devices rather than new ones. If new devices or technology are introduced, making sure that it is simple to use and is not combined with too many other types of devices or technology is another way to help participants stay the course of a DCT.

“It was simply too ambitious to use so many devices. I think the study would have been more successful had they been more selective and had a lower number of devices because the burden was perceived by the patients to be very high.” Interviewee 0053 (Vendor)[1]

The needs of the trial participants must be central to designing a DCT to make sure that the requirements do not burden them too much with extra time demands on top of their daily routines and care needs. Participants also need to have a clear picture of how they want to be involved in the trial. Do they prefer home visits, or would they find these stressful and burdensome? Would they prefer entirely decentralised models, or does this lead to confusion and a feeling of isolation?

While DCTs open a new frontier in clinical trials and have the potential to make trials faster, cheaper and more accessible, leading to quicker drug development, it is important to manage the expectations of participants. DCTs are an evolving new approach of conducting clinical trials, in which the participant is more involved and plays a crucial role. It should be clear for participants that this new approach does not promise better results or less burden for the participant and their involvement will not guarantee a new cure or therapy.

[1] https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.15003

DCTs may raise new challenges for study sites which include:

  • Ensuring the participants’ privacy during telemedicine appointments and home visits
  • Managing differences in data collected at home versus supervised tests at a study site
  • Managing adverse events remotely without any physical interaction with the participant
  • Providing correct and adequate training to study staff
  • Ensuring proper management of clinical trials fully remotely
  • Cost of carrying out the DCT can be higher depending on the chosen DCT approaches
  • Dealing with large amounts of data[1] collected from different devices or technologies

These aspects need to be carefully considered during DCT design, and each issue addressed individually.

[1] Operationalizing Decentralized Clinical Trials: Technology Insights from the Trials@Home RADIAL Proof-of-Concept Trial

Digital literacy – or a participant’s ability to deal with the DCT technology requirements without too many issues – is crucial to a participant’s successful involvement in DCTs, which include technologies.

It is important to establish the basic digital skills trial participants will need to be able to carry out their part of the DCT effectively. This means a DCT should have a list of digital skills needed before the recruitment is launched. These skills must be explained to potential participants. Training should be provided to be able to use the chosen technology, provided that the foundation for the basic skills is present and that the training will not become too complex and overwhelming.

Adequate digital literacy is not only needed from trial participants – it is also required of those conducting the DCTs. They should be able to confidently navigate the technology requirements of the trial and have an understanding that allows them to easily and simply explain the technology to trial participants.

Logistic considerations include how the medication is being delivered to or collected from DCT participants. Medications can be either provided to a participant by a nurse or sent via a courier. Patients can also pick up trial medication from a pharmacy themselves. These methods all depend on the design of the trial and local regulations and may vary from one trial to another.

Logistical expectations and considerations for DCTs include:

  • Where the medication is coming from and how
  • How the medication is stored in transit and once received (e.g. temperature control)
  • Possible delays to receiving or sending the medication
  • Home nurses, courier companies and local pharmacies handling medications must be within the necessary regulatory permissions to do so legally

Clinical trials are a tightly regulated area, and with good reason. Regulation by the responsible authorities ensures that trials are conducted safely and transparently, aiming for a beneficial outcome. Regulatory authorities differ across geographical regions and often have different policies; this is particularly challenging for DCTs as the study centre might operate for a larger (cross-border) geographical area.

Keeping regulatory authorities in the loop early and clearly is a way to avoid the trial being rejected and also to avoid misunderstandings that may halt a DCT or cause it to be delayed because of lack of clear regulatory guidance.[1]

Regulatory authorities will often have expectations around:

  • Data collected and what is done with it
  • Study site registration with the relevant authorities
  • Correct training of staff
  • How medication is delivered to trial participants
  • Regulatory oversight

In Europe, regulatory authorities used to be hesitant about sending trial medication directly to trial participants. However, this has now changed although it differs from country to country or even within different regions in the same country.

[1] https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.15003

Quiz

Question 1:

Which of the following is not considered a potential challenge for sites conducting DCTs?

(Select the answers you think are true)

Question 2:

The privacy of patient data is not something DCTs need to consider

True or false?

Correct!

Incorrect!

Question 3:

Trial participants need to have an adequate level of digital literacy for effective participation in the DCTs which involve technology

True or false?

Correct!

Incorrect!

Question 4:

A courier company handling medications needs to be within the regulatory requirements of the country it operates in to carry out this duty

True or false?

Correct!

Incorrect!

Question 5:

Regulatory authorities across various geographical regions have the same expectations regardless of where they are based

True or false?

Incorrect!

Correct!

Question 6:

Keeping regulatory authorities informed and involved from the outset in a DCT can ensure the smoother running of a DCT

True or false?

Correct!

Incorrect!

CHAPTER 4: Co-creating DCTs – engaging with the target participant group