Decentralized Clinical Trials: Scientific Considerations Through the Lens of the Estimand Framework
Izem et al.
The finding, in our words
The authors propose applying the ICH E9(R1) estimand framework to decentralised clinical trials to systematically evaluate each decentralisation component. This approach reveals how off-site data collection changes the scientific questions being addressed, exposing both new opportunities and hidden assumptions that affect trial validity.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
The Australian Teletrial Programme improved patient access to trials and workforce capability through harmonised processes and training, but broader implementation is limited by workforce turnover, complex approvals, and variable leadership engagement. This highlights that systemic policy and governance support are critical for the sustainable integration of decentralised trial models.
Sabesan et al., Journal of telemedicine and telecare (paywalled) · source ↗
The study identified 48 strengths, 62 weaknesses, 5 opportunities, and 13 threats across eight key trial activities in decentralised clinical trials, highlighting potential advantages like remote participation and challenges such as digital technology barriers and privacy issues.
Murciano-Gamborino et al., BMC medical ethics · source ↗
Experts achieved high consensus on recommendations to support decentralised clinical trials in Europe, including training for health care professionals, improving biological sample logistics, and fostering regulatory harmonization. These prioritized solutions aim to overcome barriers to adoption and create more inclusive and efficient research frameworks.
Murciano-Gamborino et al., Journal of medical Internet research · source ↗
A recommendation paper on extending decentralised elements in trials, covering the conditions under which trial activity, including biological sample collection, may take place away from the investigator site.
Bond et al., Therapeutic Innovation & Regulatory Science · source ↗