Sentence examples for comparability trial from inspiring English sources

Information on comparability trial data and extrapolation can be found in a biosimilar medicine's European Public Assessment Report.

While survival is generally a preferred endpoint in oncology clinical trials, survival endpoints may not be appropriate for a biosimilar comparability trial as they can be influenced by confounding factors such as tumor burden, disease status, and previous lines of therapy.

In Mexico, there is already legislation that requires comparability trials with the reference biologic, but the request for marketing these products was introduced before the new regulation was effective.

Baseline breastfeeding rates will be collected to allow a before and after analysis of breastfeeding rates in each LGA, and to assess comparability of trial arms at trial commencement.

According to biosimilar guidelines from European Medicines Agency (EMA) and US Food and Drug Administration FDAA), comparative clinical trials for pharmacokinetics (PK) and efficacy are required for demonstration of clinical comparability, preferably double-blind, normally equivalence trials.

Many generic and disease specific quality of life and health survey measures exist. 2 8 Some are difficult to compare or are prone to methodological shortcomings and suboptimal validation. 1 2 9 10 11 To maximise comparability across trials covering diverse diseases and interventions we focused on trials using short form-36 (SF-36).

A high risk of bias and insufficient comparability across trials prevented quantitative data synthesis.

13 This increases comparability between trials and limits bias, such as the censoring of events after intervening revascularisation.

How then can research teams allow for some acceptable level of heterogeneity while maintaining robust comparability across trials?

The use of core sets of outcome measures greatly enhanced the comparability of trials in rheumatic disorders.

In addition, well-defined diagnostics should be employed to make a precise clinical diagnosis of angina, thereby increasing the comparability between trials.