Exemplars of current practice, such as those identified in our study, should be evaluated for feasibility and acceptability in representative general practice settings as well as tested for efficacy, safety and cost.
As for efficacies, although both studies failed to show a statistically significant improvement in overall survival, a significantly better DFS was shown with the adjuvant gemcitabine.
Also, evaluation of SV2C (as well as other candidates) as a marker for efficacy will be conducted in the E5103 trial, as efficacy data become available.
Robert Spitzer, whose research continues to be cited by reparative therapists as evidence for efficacy of sexual orientation change efforts, admitted that his studies were fatally flawed.
Seizure resolution was most frequently adopted in the studies as outcome for efficacy.
In addition, PD or PK endpoints may be used as surrogates for efficacy.
Neoadjuvant chemosensitivity and endocrine sensitivity rates are increasingly accepted as surrogates for efficacy, especially if substantial impact can be demonstrated.
If indeed there is a link between hypertension and effectiveness of the drug, biomarkers for toxicity may also serve as markers for efficacy.
Subjects were allowed a one-step dose adjustment as required for efficacy and/or tolerability 4 and 5 weeks after switching.
The main analysis considered studies that compared the above regimens against 6 month isoniazid (taken as reference) for efficacy and heptotoxicity (table 3).
