Of the 2,179 subjects included in the factor analysis, 2,174 subjects had baseline data and at least one post-baseline efficacy evaluation for inclusion in the efficacy sample.
5 In total, 287 patients entered the study and 280 were analyzed as the efficacy sample.
Across all arms, 119 patients (5%) in the efficacy sample underwent radical surgery, of which 74% were liver metastasectomies, 13% lung metastasectomies, 9% primary resections (with or without liver metastasectomy) and 4% other sites.
IP-10 has been suggested as a marker of TB treatment efficacy – serial samples show reductions in levels at 2 months in cured TB patients, with no reduction in non-responders [15].
In BC, immunohistochemical assessment of Ki67 has been validated as a dynamic biomarker of endocrine treatment efficacy in samples taken before, during and after neoadjuvant endocrine therapy [ 17].
Finally, there is increasing interest in the correlation of serum drug levels of anti-TNF agents and antibodies against these agents and efficacy, but samples for assessment of pharmacokinetic parameters were not collected during CHARM or ADHERE.
Given the need for a robust mtGenome assay that could be applied with equal efficacy across samples representing diverse mtDNA haplogroups, the potential for primer binding site mutations was given careful consideration in the design of codR amplification primers.
To ensure robust inference about temporal and spatial trend estimates in the state variables of interest, the efficacy of sampling designs should be carefully gauged at the design stage to ensure sufficient statistical power, and data should be collected according to a formal randomized design to allow for regional-scale inference.
Based on this study's primary feasibility and preliminary efficacy outcomes, sample size was based on resources available.
Expected efficacy and sample size estimates were presented for each trial with considerations for dropout or loss-to-follow-up.
