Impact & KPIs

Economic insights

Setting up and conducting clinical trials is costly, and some have raised concerns that expenditures may increase. Introducing DCT elements could further increase clinical trial costs, particularly for technology set-up and online recruitment methods. However, DCTs also have the potential to achieve cost-savings, if they can accelerate patient recruitment and improve retention, enhance the efficiency of visits, and reduce or eliminate patient-related financial burden, such as transportation costs and productivity losses. We provide recommendations on cost considerations in DCTs.

Recommendations

Evaluate the added value of DCT elements in relation to costs

The feasibility and added value of the DCT elements should be considered in context of the study population. Relevant cost drivers to take into account are speed of enrolment, retention, overall trial timelines, and trial size. Trial size can be relevant, as some elements, like telemedicine or custom apps, have high upfront costs but scale well for large trials. Other costs, such as direct-to-patient IMP shipments or home diagnostics, increase with participant numbers. Consider opportunities to reduce initial costs over time through experience, centralised logistics, or reuse (see below), and evaluate if these weigh up against the added value for participants.

‘Reduce, reuse, and recycle’ technology

Minimise complexity and costs for sites and patients by having a minimal number of interfaces and processes, thus keeping the cost of training and required resources low. We suggest combining all digital technologies on one device or portal; limiting the number of vendors that manage third-party services; prioritising reuse or adaptations of proven solutions rather than creating new custom developments (e.g., standardise reusable templates and platforms across trials for eConsent).

Gain experience with DCT elements to reduce study personnel costs

Many study sites still have limited experience with decentralised elements. Therefore, time of study personnel for the set-up of DCT elements, and issue management during follow-up are expected to reduce in the future when they have more experience.

Centralise logistics

Centralise logistics management with a single depot where feasible, limiting costs related to inventory management and individual shipments.

How Trials@Home reached these recommendations

Relevant cost components of the RADIAL trial were mapped into a costing overview, stratified by actionable phases of the trial: set-up, recruitment of participants, and follow-up of the intervention. A mixed methods approach was used to estimate the costs, tailor-made for each cost-component. These consisted of a mix of invoices, tariffs (e.g. salary scales), literature data, information recorded in the electronic case report form (eCRF), questionnaires, and expert elicitation. As elements of costs were specific to Trials@Home and the RADIAL study, qualitative insights were gathered through sixteen semi-structured interviews with study personnel to give insights into what aspects of introducing decentralised elements were particularly costly, why, and if this is expected to be similar in the future.