2023 · Therapeutic innovation & regulatory science · open access
Applying Systems Thinking to Inform Decentralized Clinical Trial Planning and Deployment
Betcheva et al.
The finding, in our words
The authors propose a systems-thinking framework for evaluating decentralized clinical trial deployments, concluding that solutions must be customised to patient needs and trial requirements while identifying implementation enablers to address new systemic demands. This matters because it offers a structured approach for planning patient-centric decentralised studies, though it calls for further empirical validation.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
In four crew members, capillary volumetric absorptive microsampling caught altered acetaminophen pharmacokinetics in flight: Cmax rose to 43,300 ng/mL from 9,110 before flight and clearance fell to 3,890 mL/h from 16,200, pointing to toxicity risk at standard dosing; four people only, but a case for microsampling where no clinic can reach.
Mampre et al., Journal of clinical pharmacology · source ↗
Ten decentralised cancer trials run across 47 Veterans Affairs medical centres enrolled 134 patients, nearly a third of them rural and a fifth from minority groups, matching the population the VA's tele-oncology service already reaches. The authors' own caveat stands: remote conduct widened access, and not every trial design can be run this way.
Friedman et al., Journal of the National Cancer Institute (paywalled) · source ↗
The study observed favourable trends in the accrual of participants residing far from the site and those from underrepresented groups following the implementation of a decentralised clinical trial program.
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 ↗
This review suggests that decentralised clinical trials in oncology can improve patient participation and equity but face significant regulatory, logistical and digital hurdles. It concludes that these trials offer a flexible model dependent on specific clinical contexts rather than a universal replacement for conventional methods.
Gentile et al., Critical reviews in oncology/hematology (paywalled) · source ↗