CROS NT Joins PHUSE Eu 2021

PHUSE EU Connect 2021

We are pleased to announce that this year we will be joining PHUSE EU Connect 2021 as delegates and sponsors of the hands-on workshop “Clinical Trial Safety Analyses – Common Pitfalls and FAQ” conducted by Eli Lilly.  Event information: Event format: Hybrid Date: 15 – 19 November 2021 Registration & agenda: available on the official website…

Webinar Maximise the Effectiveness of Your CRO Partnership

Webinar Replay: Maximise the Effectiveness of Your CRO Partnership: Best Practice for Success

While the Sponsor/CRO relationship is common, its effectiveness can be reduced due to miscommunication about expectations and inadequately defined responsibilities and accountabilities. By developing key strategies and documents, you can significantly boost the effectiveness of your CRO partnership, allowing you to leverage the collaboration to meet critical clinical trial benchmarks and milestones, on time and…

Clinical Trials in Small Patient Populations

Effective Trial Design: Clinical Trials in Small Patient Populations

Progress in biomedical science leads to highly effective targeted therapies in certain diseases, such as specific types of cancer or multiple sclerosis. These targeted therapies offer large benefits to often a small subpopulation of all patients affected by these specific diseases. Rare diseases and pediatric indications can also present a similar challenge inherent in their…

Data Oversight

Webinar Replay: Clinical Trial Data Oversight: Why and How?

On the 21st of July 2020 CROS NT conducted a webinar focused on clinical trial data oversight. During the webinar titled “Clinical Trial Data Oversight: Why and How?”, we reviewed oversight as it relates to data collection and reporting, analysed options for oversight including an assessment of different approaches, discussed the benefits of a centralized…

The Approaches of Successful Sample Size Calculation

The Approaches of Successful Sample Size Calculation

In an extract from our CROS Academy course: “Understanding Study Designs & Successful Sample Size Calculation”, we discuss the different approaches to sample size calculation and why it is an important statistical component in successful clinical trial methodology and strategy. The target of drug development is to license a drug for a particular disease which…

Webinar highlights: Dual roles: I am not just a programmer

Webinar Highlights: 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…

Programmer

Webinar Replay: SPO1: Dual Roles. I’m not just a programmer!

On the 31st of March 2020 CROS NT conducted a webinar focused on the ways statistical programmers can work in dual roles and expand their skill set, as well as support different operational groups and get involved in the upfront project planning. Webinar learning outcomes: Importance of retaining employees through professional development How statistical programmers…

Innovations in Clinical Trial Design

Webinar Replay: Innovations in Clinical Trial Design: Patient Enrichment Approach for Placebo Non-responders and Responders

On the 9th of April 2020 CROS NT conducted a webinar focused on the use of enrichment designs for reducing placebo response and thereby enhancing signal detection. This webinar described the use of a Sequential Parallel Comparison Design (SPCD) to increase the chance of success of clinical trials, especially trials with possibly high placebo effect.…

MCP-Mod approach

The MCP-Mod Procedure for Dose-Response Testing and Estimation

Summary: The MCP-Mod approach affects both the design and the analysis of dose-finding studies. It is a hybrid approach that combines hypothesis testing and modeling to analyze phase II dose-ranging studies with the purpose of finding suitable dose(s) for confirmatory phase III trials. The MCP-Mod method was found adequate and appropriate for dose selection based…

Structural Equation Modeling

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…

basic statistical

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…

The Cost of a Failed Clinical Data Strategy

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 -…

Cloud-Based eClinical Solutions

Strategic Clinical Data Outsourcing: Cloud-Based eClinical Solutions

When it comes to clinical data outsourcing, Sponsors rely on several factors to select and qualify vendors. The most prevalent outsourcing method remains the use of full-service CROs, but there is a growing trend to outsource based on CRO specialization including biometrics services and technology offerings. The centralized clinical data approach keeps all clinical data…

The value of meta-analysis

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

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…

Advantages and Disadvantages of Endpoints in Oncology Trials

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

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.…