Decentralised clinical trials (DCT) often use new technologies or processes to create options for participation outside of conventional clinical trial settings. These so-called virtual trials improve convenience and provide access to research for patients. This enables the participation of people who are less mobile or live further away. (cf. Khozin & Coravos, 2019)
Especially during and due to the ongoing COVID-19 Pandemic, these DCT have become the focus of current research. The difference between DCT and normal CT is that technologies and services are used, such as home nursing or telehealth, to decentralize by improving the management logistics of clinical trials and tracing the patient’s individual experience in their everyday settings. (cf. Khozin & Coravos, 2019)
1. “Anticipate and mitigate DCT-specific risks.”
It is important to know and minimise possible risks, for example, it is important to supply the appropriate dose of a drug to a patient when the study is discontinued, so that there are no gaps in supply and no health risks even if the study is aborted by the patient.
2. “Think through every aspect of DTP logistics.”
Logistical processes must be fully thought through so that each patient receives the appropriate supplies, equipment, etc., and the delivery and storage of the needed items is guaranteed at all times.
3. “Embrace the expertise and motivation of patients and their caregivers.”
In contrast to conventional CT, patients and their individual expertise are taken into account and are actively involved in DCT. Many long-term patients have an enormous amount of knowledge about their disease, so it is efficient to use this knowledge in the research process.
4. “Plan ahead for complications in eConsent and telehealth.”
DCTs are using digitalisation to facilitate patient engagement and onboarding. For example, through the use of electronic consent forms and telemedicine, i.e. medical video calls where several people are present, such as a patient’s parents or other relatives. In this way, all persons to be informed can participate regardless of their location.
5. “Validate the processes in which new technologies will be used.”
Before using a new technology within a DCT, it is important to learn about it. There are three questions to consider: 1.) “Does the technology work as intended?” 2) “How does the patient consent to the technology?” and 3) “How is access to the data granted, and how are access rules defined?”
Ki:elements uses artificial intelligence and natural language processing technologies for the speech-based assessment of neurological and psychiatric pathologies, resulting in so-called pathological markers – speech biomarkers. These can be used, for example, as endpoints in pharmaceutical studies or to enrich the study population in the recruitment phase before the start of a study, as well as for differential diagnosis or therapy monitoring of diseases with a volatile course.
The article we summarize presented 10 rules instead of these 5. Here is the original article for further reading.