As more companies sign on, the potential scale of the pooled clinical trial data is unprecedented – especially for an industry that is often cloaked in controversy or mired in headlines announcing billion dollar fines.
Firstly, this was a post-hoc analysis of pooled clinical trial data.
We conducted post hoc analyses of pooled clinical trial data from seven phase II and III randomized, double-blind, placebo-controlled, primary hyperlipidemia and T2DM clinical trials.
21 58 We reached the same conclusions as analyses that used VISTA data or the limited pooled randomised trial data in elderly patients.
In the pooled clinical trial data for exenatide BID (N = 2279 subjects), the relative risk of at least one CV event was 0.69 (95%CI 0.46 1.04) for patients treated with exenatide BID compared with the pooled comparators.
32, 33 For example, retrospective analyses of pooled clinical trial data for sunitinib in patients with metastatic RCC have preliminarily identified treatment-associated fatigue as a potential biomarker of sunitinib efficacy.
Mean baseline scores for each clinical assessment and the six WFIRS-P domains were nearly identical between the two random half-samples.> -wrap-foot> aSample 1 refers to the first random split half-sample from the pooled clinical trial data.
Here, we report the results of post hoc integrated analyses of pooled clinical trial data conducted to evaluate the efficacy and safety/tolerability of colesevelam in older adults (men and women aged ≥65 years) as well as younger adults aged <65 years.
Analyses from pooled clinical trial data demonstrate that the most frequently reported AEs experienced with pirfenidone, versus placebo, were nausea (32% vs. 12%), rash (26% vs. 8%), diarrhea (20% vs. 14%), fatigue (19% vs. 10%), dyspepsia (16% vs. 5%), anorexia (11% vs. 4%), headache (10% vs. 8%), and photosensitivity reactions (9% vs. 1%) [ 23].
Meta-regression is a variant of meta-analytic technique that allows for a more in-depth understanding of the pooled clinical trial data, by "exploring whether a linear association exists between variables and a comparative treatment effect, along with the direction of that association" [ 24].
