Background
Clinical research is often site-centric, adhering to schedules largely driven by tradition and operational convenience rather than the natural history of diseases, and the diversity of target populations.1 It stands to reason therefore that the patients recruited to clinical trials do not always reflect real-world clinical presentations, which in turn can bias the findings and limit their applicability to real-world settings. However, in reality, few studies are totally site-centric with treatment often self-administered at home, between study-site visits; some data capture may also occur between site visits—for example, patient-reported outcomes (PROs).
Restrictions on movement imposed during the COVID-19 pandemic, disrupted many site-centric clinical trials and accelerated the interest in and growth of digitally enabled clinical research including trials.2 3 Challenges previously perceived as insurmountable were overcome in weeks as ethics committees, regulators, study sponsors, clinicians and patients alike, embraced new approaches like digitally enabled screening, recruitment, remote consent and data capture that were able to provide assurances that rigour and patient safety would not be compromised.
The US Food and Drugs Administration (FDA) defines decentralised clinical trials as trials executed through telemedicine and mobile or local healthcare providers, using procedures that vary from the traditional clinical trial model.4 Patient recruitment, delivery and administration of study medication, and collection of study outcomes data occur without in-person contact between the study team and patients in fully decentralised trials.2 This definition could be expanded to encompass non-trial clinical research. In this article, we explain these innovations and limitations.