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…
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…
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…
To mark the occasion of Rare Disease Day 2021, on the 4th of March we were repeating our complimentary webinar “Effective Trial Design: Clinical Trials in Small Patient Populations”. Together with the participants, we discussed the benefits and challenges of three types of the following designs: Designs where each patient serves as his/her own control…
“My clinical study is powered at 80%. It, therefore, has an 80% chance of being successful”. In reality, the actual chance of success could be a lot lower. A lot of people are familiar with the concept of statistical power when planning their clinical trials and when deciding how many patients they need to treat.…
Last year was marked by the COVID-19 pandemic that has changed our lives and the Life Sciences industry. A lot of traditional ways of operation were disrupted, challenging industry professionals and at the same time, providing opportunities for the development of new approaches and strategies. We spoke with Lisa Comarella, Director of Biostatistics of CROS…
Designing and conducting clinical trials in indications with inherently small patient populations, such as rare disease, can be quite difficult. The limited number of patients available for the trials has a direct impact on the difference in clinical outcomes that can be detected between treatment groups. Another challenge is the extended time to recruit the…
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…
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…
On May 28, CROS NT hosted a complimentary webinar on reducing risks and costs in clinical trials. This webinar gave a brief introduction into current trial designs that can help to decrease the risk of failure and reduce the costs and discussed their advantages and disadvantages. The webinar was conducted by Thomas Zwingers, Statistical Consultant…
Would you like to learn more? Watch the recording of our webinar “Innovations in Clinical Trial Design: Patient Enrichment Approach for Placebo Non-responders and Responders”.
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…
On the 28th of May 2020 CROS NT conducted a webinar focused on current trial designs that can help to decrease the risk of failure and reduce the costs, we have also discussed their advantages and disadvantages. Webinar learning outcomes: Basics of adaptive designs How to evaluate the benefit of an adaptive design for biopharma…
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…
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.…
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…
The role of the Statistical Programmer is increasingly important in the overall clinical trial process. Statistical programming has become more of a niche role in which the programmer is tasked with turning data into comprehensive analysis and knowledge for the rest of the study team. Programmers are expected to not only have programming knowledge, but…
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…
The primary responsibility of the Data Monitoring Committee (DMC) throughout the duration of a trial is to ensure the benefit to the patient outweighs any potential risk. CROS NT’s biostatistics team looks at the challenges of ongoing analysis for a DMC. The DMC generally carries out the following activities: Periodic review and evaluation of accumulated…
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…
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 -…
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 biostatistician plays a crucial role in the drug and device development process – from protocol development to data analysis and regulatory submissions. We look at how the statistician is involved from study set-up through to analysis and why it is important for other clinical trial professionals to understand the role statisticians play in the…
The most prevalent outsourcing strategy among drug development companies remains the use of different full service CROs. However, there is a growing trend to split the component services of a trial among two or more companies in order to minimize risk, obtain greater efficiencies and make considerable savings. Using a variety of full service CROs…
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…
Superiority trials are a common design in clinical trials and are well accepted as proof of efficacy for investiagational drugs. But more and more, non-inferiority trials are being used. CROS NT discusses the main reasons why these trials are used and how to design and analyze these trials according to our top biostatisticians. There are…
CROS NT explains how choosing the right statistical method accompanied by the right technology for your clinical study design can reduce timelines and lower costs while maintaining the quality and validity of a study. In recent years, the pharmaceutical industry is witnessing a significant increase in costs for the development of new drugs. Companies site…
The 4th of February is recognized around the world as World Cancer Day, and this year’s theme is “Not Beyond Us” which focuses on the positive and proactive approach to cancer and the fact that solutions and treatments do exist – solutions that CROS NT is regularly involved in through the analysis and reporting of…
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…
Statistics play a crucial role in clinical trials and in the drug development process – from trial design to protocol development. Having a fundamental understanding of statistical issues can uphold the integrity of a clinical trial and improve communication between clinicians and statisticians. As a clinical trial professional, non-statistician, are you familiar with the following…
According to a recent report (Millennium Research Group), the orthopedic device market is growing steadily, and this is due to several changing factors in the industry. There has been a significant increase in devices for the treatment of extremities including devices for hands, wrists, elbows, shoulders, feet and ankles. This market change is due to…
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.…
According to CROS NT’s expert biostatistician, how can adaptive trial design be a method for the future of cancer research? During Phase III development, efficacy of the drug should be confirmed. Many new products have to find a very specific mechanism of effectiveness, so therefore subpopulations are necessary. Flexible study designs that allow for early…
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.…
Oncology is a main area of focus for many pharmaceutical and biotechnology companies around the world. The facts about cancer are startling: cancer claims over 7 million lives each year and the number continues to grow. It is no wonder why drug development companies are focusing on this complicated therapeutic area which has over 450…