Key webinar highlights: Dual roles: I am not just a programmer

Dual Roles: I am not just a programmer!

The most satisfied and hard-working employees are those who feel challenged and supported in their professional development. Employees at CROS NT can work in dual roles, not only in management but also in operational areas. This gives experienced employees the opportunity to move into roles with more leadership potential or which demand higher-level or different…

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The Role of FSP in a Risk-Based Approach

The ICH GCP Guideline integrated Addendum provides a unified standard to facilitate the mutual acceptance of clinical data by regulatory authorities in the European Union, Japan, the United States, Canada and Switzerland. The ICH GCP E6 guideline was adopted in 1996, and clinical trials have evolved substantially in the past 21 years. The (E2) addendum…

biostatistics_clinical_trials

The Case for Structural Equation Modeling in Clinical Trials

In this week’s blog, the CROS NT Biostatistics Methodology team presents a description of how Structural Equation Modeling (SEM) can be used in clinical trials. Structural Equation Modeling is a set of mathematical models and statistical methods used today in biostatistics. However, its use in clinical trials has not been widely accepted yet. CROS NT…

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The Value of Basic Statistical Training for Clinical Teams

In the complex world of drug development, the interaction between the various stakeholders is essential for the success of a project. A fundamental part of communication is a basic understanding of the problems, terminology and way of thinking of your team members and partners. Traditionally, statisticians have a particular way of thinking, which is very…

clinical_data_analysis

The Cost of a Failed Clinical Data Strategy and How to Avoid it

How can Sponsors plan effectively in the trial design and clinical data strategy phase? Drug and device development is a grueling process with long timelines and excruciating costs. Throughout the trial process, Sponsors often face obstacles that delay timelines and inevitably increase costs. Even more frustrating, the odds of success are stacked against Sponsors –…

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Understanding the Value of Meta-Analysis

The combination of single trials into one meta-analysis provides a more precise and stable estimate of the treatment efficacy than analysis provided by each single trial. Evidence-based medicine is one of the most efficient ways to prove efficacy in randomized clinical trials. CROS NT discusses why meta-analysis is becoming more relevant in clinical trial data…

Good Practice Designs: Biostatistics for Breast Cancer Trials

October is Breast Cancer Awareness Month, and CROS NT is addressing the implications of conducting clinical studies in breast cancer and how Sponsors can implement smart designs and strategies to conduct more efficient trials. Oncology is perhaps the most complex therapeutic area in clinical trials with over 450 indications and various unique characteristics like slow…

The Advantages and Disadvantages of Endpoints in Oncology Trials

In this week’s blog post, we look at an extract from an article written by CROS NT’s expert biostatistician, Thomas Zwingers, on adaptive trial design for oncology studies. How can biostatisticians use adaptive trial designs to deal with the advantages and disadvantages of endpoints in oncology studies? Oncology is significantly different than other therapeutic areas.…

Measuring Uncertainty in Medical Device Trials with Adaptive Designs

Biostatistics is the study of uncertainty and determining how to measure it and how to react based on the results. Medical Device trials face the following uncertainties: Safety Problems Unexpected treatment effects/safety issues High variance Effects in secondary endpoints/subpopulation Reducing uncertainty in the planning phases of device development can eventually reduce timelines, and inevitably, costs.…