Karen Nooman
Senior Vice President, Global Regulatory Policy, ACRO
Studies that are intentionally planned as decentralised clinical trials provide the best opportunity to optimise the patient-centred capabilities of decentralisation.
You would not buy a sportscar and just use it for the two-mile drive to the shops. Instead, you would take it on the open road to take full advantage of its capabilities. The powerful flexibilities of a decentralised clinical trial (DCT) are only realised when a study is intentionally planned, from the start, as a decentralised trial.
Agility of decentralised clinical trials
The COVID-19 pandemic put a spotlight on the agility of DCTs. Core remote capabilities – such as direct-to-patient shipment of IMP and telemedicine visits – enabled researchers to keep many ongoing studies up and running. However, it is clinical studies which are intentionally planned and designed as DCTs – from the start – that fully optimise the value of decentralisation.
A planned DCT enables the development of a robust protocol with two key ingredients: first, early engagement across all stakeholders and second a risk-based, quality-by-design framework.
DCTs offer a rich continuum of locational flexibilities to patients – including local labs, local (or mobile) imaging centres and local pharmacies.
Understanding new trial burdens
Early patient engagement is crucial to learn how to best leverage decentralisation to mitigate patient burdens. However, it is equally important to understand how adopting a decentralised approach might introduce new burdens – such as IT barriers and privacy concerns about strangers entering the home – so that these can be addressed and mitigated before the protocol is developed.
DCTs offer a rich continuum of locational flexibilities to patients – including local labs, local (or mobile) imaging centres and local pharmacies.
Quality by design framework
In addition to early stakeholder engagement, a planned DCT permits the adoption of a quality-by-design framework with robust risk considerations. The ACRO DCT Working Party has created a DCT Toolkit, with detailed manuals on how to implement a risk-based quality by design approach to DCTs.
Untethering trial activities from hospitals and other medical sites was a powerful factor in continuing clinical trials during the COVID pandemic. Planning decentralisation from the beginning of a trial is an even stronger force in decreasing burden on patients and investigators as well as facilitating trial participation.
