Important data for future research will include feasibility of recruitment, and retention to a large scale trial, and estimates of effect sizes on key outcome variables which can inform future power calculations.
The sample required for this is not based on a formal power calculation but on a pragmatic decision balancing sufficient numbers to be able to identify likely barriers to carrying out a larger scale trial, and cost.
If a league gets off the ground as soon as 2014, players will be recruited via combines – large-scale trials – and through the development of a scouting network with the help of coaches at leading colleges who can recommend players with potential who are unlikely to be drafted by the NFL.
Although meta-analyses have been subject to considerable criticism, individual patient data meta-analyses provide the best overall evidence of treatment effect in the absence of large-scale trials and have been instrumental in providing objective data that can be used in the design of new studies.
This overview summarizes the results of that trial, the design of other large-scale trials, and advances in understanding of the molecular mechanisms underlying the effect of other promising agents, including dutasteride, selenium, Vitamin E, Vitamin D, COX-2 inhibitors, lycopene, and green tea.
This report will describe the rationale for the trial and currently available randomized trial data, summarize related ongoing large-scale trials, and provide a brief overview of study design, and an update on randomization milestones, racial/ethnic diversity, biorepository activities, in-depth phenotyping of a subcohort, and ancillary studies.
A number of large-scale trials and demonstration studies of LED-FM systems have recently been completed and results are awaited [23].
138, 139 The optimum protocol will hopefully emerge from the large-scale trials and studies currently in progress.
The optimum protocol will hopefully emerge from the large-scale trials and studies currently in progress [ 81, 109, 111, 122, 123].
Such a PROM should be suitable for use in large-scale trials and capable of measuring outcomes over various time periods.
