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Assessing the potential for prevention or earlier detection of on-site monitoring findings from randomised controlled trials: Further analyses of findings from the prospective TEMPER triggered monitoring study.

William J CraggCaroline HurleyVictoria Yorke-EdwardsSally P Stenning
Published in: Clinical trials (London, England) (2020)
This work presents a best-case scenario, where a large majority of monitoring findings were deemed theoretically preventable or detectable by central processes. Caveats include the cost of applying all necessary methods, and the resource implications of enhanced central monitoring for both centre and trials unit staff. Our results will inform future monitoring plans and emphasise the importance of continued critical review of monitoring processes and outcomes to ensure they remain appropriate.
Keyphrases
  • type diabetes
  • adipose tissue
  • metabolic syndrome
  • skeletal muscle
  • risk assessment
  • insulin resistance
  • glycemic control