The Trials&Home DCT course
CHAPTER 2: Know the most common DCT elements
A DCT can either be fully remote or merely contain DCT elements. Trials that only contain some DCT elements are considered hybrid clinical trials. DCT approaches are quite common in clinical trials, although fully remote DCTs are less common. To fully explore which elements are included in DCTs, we’ll cover the basic building blocks of a clinical trial, then explain how these could be done in a DCT versus a conventional trial.
Common DCT elements
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In any clinical trial, the researchers will need to find people suitable to participate in the clinical trial. This is known as participant outreach, or recruitment.
On site: Researchers may recruit patients through healthcare centres or referrals from other (non-participating) centres. The healthcare centres can review their patient records to identify potential patients or use other media on site (posters) to encourage patients to enquire about participation.
DCT: Researchers might use social media, digital advertising, or mail campaigns to reach potential patients.
Before patients can join a trial, the researchers will need to make sure they are eligible to participate.
On site: The patient could visit a hospital or a clinic to be examined by a healthcare professional.
DCT: The screening might be conducted through a web-based form or over the phone, followed by a video call for the rest of the screening. The patient may also be asked to perform basic medical tests at home, e.g. take blood pressure or a blood sample. This can be done by the patient or by a home nurse.
In any clinical trial, participants need to give informed consent before they can begin the trial. This means they will be informed of everything that will happen in the trial, especially where relevant for informing their decision. For example, they will be informed of any medical procedures required (e.g., blood draws), how their data will be used, any potential risk or benefits, what their rights are etc.
On site: Informed consent is usually done in-person before the start of the trial procedures, usually at the trial site. The trial staff explains everything to the patient and answers any questions they have.
DCT: The discussion might take place over the phone or a video call, then the consent form could be remotely signed or can be mailed, e-mailed or faxed to the participant.
Although most of the interaction between participants and study staff takes place during visits, there is also a need to maintain communication outside these visits. This is known as asynchronous investigator-participant interaction. These interactions might include the site informing participants of updates in the study or additional instructions, or sometimes participants communicating changes in their situation, such as contact details.
On site and DCT: This type of interaction is mostly already decentralised, conducted via SMS, e-mail, web portal, phone, or sometimes a trial management mobile app.
Participants often need to be trained by study staff. This is especially true in studies that involve self-administration of a therapy via injection or perform basic medical tests.
On site: Study staff train the participants at a clinic or hospital.
DCT: Participants learn how to administer the therapy or perform the study procedures through (video) instructions, telemedicine appointments, or phone conversations.
The medicine that the clinical trial is testing out is usually called the investigational medicinal product, or IMP. During a clinical trial, participants will need to receive or be administered the IMP.
On site: The IMP is given to the participants during the visit at the study centre.
DCT: The IMP could be directly delivered to the participants home, or it could be sent to a local pharmacy to be picked up, or it could be administered at the participants home by a home nurse.
Study staff needs to make sure the participants are taking the IMP as recommended (e.g. right dosage etc).
On site: During visits, study staff count the number of pills returned for example.
DCT: Participants fill out electronic diaries (e-diaries) which the site staff review regularly or participants use medical devices that record IMP administration automatically.
Monitoring is the process of quality control where the researchers make sure that participants remain safe and that the data collected will be able to answer the research questions.
On site: A representative from the trial organiser regularly visits the site to check if the protocol is being followed.
DCT: A representative from the trial organiser will communicate with the site frequently over the phone, e-mail, or consult the collected data on a shared platform online.
The study staff needs to be trained on the study protocol, design of the study, any necessary equipment, details about the IMP, and study-specific responsibilities. A representative of the trial organiser (sponsor) will give this type of training.
On site: Training will be conducted by a representative from the trial organiser, often in-person.
DCT: The representative of the trial organiser might run a web-based training system or use video calls.
Data can be collected in a variety of ways.
On site: Participants visit a clinic or hospital on a regular basis where various metrics are taken, including (but not limited to) vitals, blood draws, medical imaging, questionnaires, or physical exams.
DCT: There are many ways data can be collected decentralised. For example, through reports from the patient via e-mail, study apps, wearable devices like smart watches, sensors or biomarker kits, home nursing visits, or telemedicine appointments.
The image below shows an overview of trial elements which can be conducted decentralised. The selection depends on the trial design and participant population:
Quiz
Question 1:
What is an example of data collection in a fully remote DCT?
(Select the answers you think are true)
Correct!
Correct!
Correct!
Yes, these are indeed all examples of data collection that can be applied in a DCT.
Question 2:
Which of these is not a common component of a DCT?
(Select the answers you think are true)
Incorrect!
In a DCT participants can be recruited remotely.
Incorrect!
In a DCT the informed consent can be signed digitally.
Incorrect!
As there might not be any visit to the clinic or hospital, it’s very likely that in a DCT data is collected remotely.
Correct!
Question 3:
Where is the IMP delivered in a fully remote DCT?
(Select the answers you think are true)
Correct!
Incorrect!
Incorrect!
Correct!