Recommendations on

Activities & Operations

We gathered practical insights on trial set-up and conduct throughout our proof-of-concept DCT. What are best practices for recruitment, screening and consent? And how should decentralised activities during the trial be managed, such as sample collection and home nursing visits?

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.

DCT approaches

Several approaches have been used in DCTs to move trial activities towards participants’ homes. A selection of these, which were used in RADIAL, are shown in the figure below. Others include postal or telephone contact…

Remote recruitment and (pre)screening

DCTs minimise or eliminate the need for travel to research sites, enabling broader accessibility for participants who are not in convenient proximity to a trial site. This enables broader outreach to potential participants through online recruitment…

Remote consent

Remote consent is a key decentralised element in DCTs that enables participants to give their consent to participate in a trial without a visit to the trial centre. In a DCT, the process usually take place online …

Home shipment and collection

Direct-to-participant (DtP) shipment of investigational medicinal products (IMPs) and study materials, combined with remote biological sample collection, can reduce participant burden and improve accessibility…

Home nursing in DCTs

One way of decentralising a study visit in a clinical trial is for a nurse or other healthcare professional (HCP) to visit a participant at their home or another community location (for example, their workplace) to perform trial related activities. Such home nurse visits could either be conducted by nurses…