Crossover Designs in Oncology: Statistical Perspectives

By Vanessa Beddo, PhD (VP, Global Head of Biostatistical Consulting) Introduction There are several factors to consider when adding a crossover design feature to an oncology study.  These designs typically allow for patients to crossover from placebo or standard of care (SoC) to investigational product after disease progression on their randomized therapy.  It is also […]

Sample Size Re-Estimation: Risk Mitigation at the Planning Stage

Discover an informative webinar to explore the intricacies of sample size re-estimation in clinical trials and how assumptions around treatment effects, endpoint variability, and practical considerations impact trial success. The planned sample size for a clinical trial involves several assumptions around expected treatment effects and endpoint variability as well as practical considerations. At the trial design stage, […]

Advancing Excellence in Clinical Programming Solutions

Industry Featured Article In a recent interview with Life Sciences Review, Allucent Senior Director, Global Head of Programming, Stephen Apps, explores how to foster excellence in clinical programming solutions. The meaningful data harnessed through clinical programming has immense potential to yield successful outcomes for clinical trials. However, ever-changing regulations can make this part of the […]

The Role of Statisticians in Study Design and Why to Engage Them Early

Industry Featured Article Our latest article, published in Life Sciences Review and authored by our Allucent expert, Melanie Buitendyk, Director of Biostatistical Consulting, delves into the pivotal role statisticians play in the early stages of study design, offering insights into how their involvement can significantly streamline the development process.  In the dynamic landscape of clinical […]

Biometrics Fact Sheet

Trust Allucent as your biometrics partner for insightful data and analyses that support clinical development and regulatory submissions. We prioritize accuracy, efficiency, and communication to meet your unique needs and goals. Contact us today to learn more and download our biometrics fact sheet below. DOWNLOAD RESOURCE

5 Areas Where a Biostatistician Can Help

The FDA acknowledges the value of statisticians, involving them at every stage of the clinical trial process – and for a good reason. High-quality patient data is intrinsic to regulatory success, and must be properly managed to ensure integrity, compliance, and safety, requiring significant clinical study oversight. What role do biostatisticians play in relation to […]

Benefits of Bayesian Dose Escalation Designs for Oncology Studies

As acceptance of flexible trial designs continues to advance, many sponsors are increasingly exploring alternate methods for dose escalation to support identification of a maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) in open-label Early Phase or First in Human studies. Bayesian dose escalation designs have also coincided with advances in oncology therapy […]

Optimizing Trial Efficiency with Bayesian Dose Escalation Designs

By Vanessa Beddo, Global Head of Biostatistical Consulting, Biostatistics and Statistical Programming   As acceptance of flexible trial designs continues to advance, many sponsors are increasingly exploring alternate methods of dose escalation to support the identification of a maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) in open-label Early Phase or First in […]

Respiratory Viral Infections: Progress and Innovation

The ongoing COVID-19 pandemic has brought into focus the impact that respiratory viral infections have on the health and well-being of the world’s populations. While so-called “emerging” pathogens like the SARS, MERS, and SARS-2 coronaviruses, along with avian and pandemic influenza, tend to grab the headlines, less well-recognized is the fact that respiratory infections caused […]

What Is CDISC and What Are CDISC Data Standards?

CDISC stands for the “Clinical Data Interchange Standards Consortium,” and is a global not-for-profit organization that actively develops data standards with the collective knowledge and experience of volunteers within the pharmaceutical industry. There are three major standards that CDISC supports which are, SDTM, ADaM, and SEND. The CDISC standards for clinical studies are SDTM and […]