... and those that are known to occur in active controls or other members of the therapeutic class. Events ... observed events) with the test drug than with active controls are of particular interest. • Serious adverse events (relevant ...

... comparative effectiveness of new therapies. Direct comparisons with active controls are needed to fully evaluate the comparative effectiveness ... 35 15.9 31% 14.3 Chronic Migraine – Active control 72 Mathew 2009 Botulinum 19 9.2 41% ...

... active-controlled trial is the best option, if active control therapy is feasible and ethical, because then comparative ... investigational drug can be compared to best-available active control therapy in a single randomized controlled superiority trial. ...

... to do anything to be protected. > Three is active controls, where volitional choices need to be made. We ... the mixing vats, thereby never exposing the worker, ACTIVE CONTROLS The next group of strategies was termed active ...

... to do anything to be protected. > Three is active controls, where volitional choices need to be made. We ... the mixing vats, thereby never exposing the worker, ACTIVE CONTROLS The next group of strategies was termed active ...

... The comparison is enriched with respect to the active control comparison because the population is expected to have ... fixed-dose, dose- response studies, and sometimes with active controls as well. This approach is useful only when ...

... be designed as a randomized trial with an active-control arm. The active comparator in a phase 3, ... discuss with the FDA their choice of an active control and choice of study population before trial initiation. ...

... thus clear evidence of an effect of the active control (i.e., historical evidence of sensitivity to drug ... reasonable to estimate the entire effect of the active control (M1) at 37 percent, but given the uncertainties ...

... when possible, comparing the investigational drug with an active control. In general, HABP/VABP trials will be designed ... or 3:1 randomization of investigational drug to active control) could be considered in certain situations (e.g., ...

... year 18 areas, embracing 36 zones, were under active control, vary- ing in scope from major drainage projects ... has made it appear necessary to carry out active control measures in all areas established under the MCWA ...