Exact(1)
In 2004, denosumab was under development for treating osteoporosis, progressing from proof of concept to registration trials. 1 Questions existed that could not be practically addressed with clinical studies due to the protracted dosing interval (q6M) and required trial duration, nor by traditional PKPD models.
Similar(59)
Definitive prevention trials with cancer endpoints, such as the Breast Cancer Prevention Trial (BCPT), Prostate Cancer Prevention Trial (PCPT), and Selenium and Vitamin E Cancer Prevention Trial (SELECT), require long trial duration (up to 12 years) and large sample size (up to 32,400 subjects) to accomplish their objectives.
However, the stepped wedge design requires a longer trial duration than parallel designs and also presents a number of challenges, including both practical and statistical complexity.
Consequently, further investigations involving suitable conditions for clinical plaque control in a larger number of subjects and for a longer trial duration are required to confirm the safe and effective aPDT procedure compared with conventional treatments.
Utilizing standardized imaging acquisition protocols and more accurate measurement metrics to quantify tumour changes is expected to lower measurement variability and thus require fewer number of patients, reduce trial duration and save costs for new drug development.
However, determination of the number of patients that have to be recruited to observe the calculated number of events requires specification of the length of the accrual period, the trial duration and assumptions about the event-specific hazard functions.
Moreover, trial duration also has significant implications for the design of clinical studies, which require specific ethical as well as trial validity considerations as further discussed below.
The image remained on-screen, partially obscured by the MSIT stimulus, for the trial duration.
Fixed versus flexible dose design, trial duration and population age did not influence clinical trial outcome.
Extracted data included intervention, trial duration, study design, patient characteristics, and primary and secondary outcome measures.
Minimum trial duration was 12 weeks.
Write better and faster with AI suggestions while staying true to your unique style.
Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com