Interim analyses and safety reviews play a critical role in clinical trial oversight, providing decision-makers with timely insights while safeguarding study integrity.  In this Phase II breast cancer study, we supported three safety review committees and a formal interim analysis, delivering validated statistical outputs, independent statistical oversight, and secure management of blinded and unblinded data.  […]

In oncology trials, we rely heavily on two time-to-event endpoints: progression-free survival (PFS) and overall survival (OS). At first glance, they seem closely related—both measure time-to-event outcomes, both use similar statistical methods, and both aim to evaluate treatment benefit [1]. Historically, improvements in PFS were often assumed to foreshadow improvements in OS, but increasingly we […]

Confidence intervals are an important component of clinical trial reporting, supporting the accurate and reliable interpretation of study results.  When analyzing percentages in multicenter trials, key considerations include which confidence interval method to use and whether, and how, to account for differences between centers. For a 95% confidence interval, coverage should be approximately 95%, while […]

Progression-free survival (PFS) offers sponsors the opportunity to assess treatment benefit earlier than overall survival (OS), potentially accelerating development timelines and bringing promising therapies to patients sooner. However, while PFS is frequently used as a primary endpoint in oncology studies, its interpretation is often more complex than many stakeholders realize. This blog explores the opportunities […]

Strong partnerships and specialist expertise are key to the success of any Functional Service Provider (FSP) model. Through her role supporting Takeda, Beth McDougall works as an embedded statistical partner, providing expert oncology-focused support while collaborating closely with teams to deliver high-quality analyses and contribute to research that advances understanding across the oncology clinical trial […]

Bayesian methods are increasingly being considered to support dose optimization, extrapolation, and adaptive designs in clinical development. However, regulatory expectations vary across regions and continue to evolve.  This webinar brings together three regional perspectives on the current regulatory landscape: the FDA’s draft guidance on Bayesian statistics, China’s CDE guidance on Bayesian approaches, and Bayesian-relevant expectations […]

Designing a first-in-human study is challenging. Designing one for a novel reproductive therapy with limited prior data and significant biological variability is even more complex.  In this case study, discover how Phastar partnered with an innovative biotechnology company developing a groundbreaking therapeutic aimed at improving IVF success rates through the reduction of chromosomal errors in […]

Accelerating clinical development requires more than speed, it demands a careful balance between innovation, scientific rigor, and regulatory confidence.  In this case study, discover how Phastar partnered with a biotechnology company to develop an ambitious seamless Phase 2b/3 clinical trial strategy designed to support a critical FDA Type C meeting and accelerate progression into Phase […]

Helping an Emerging Biotech Navigate Complex Clinical Development Preparing for a first-in-human clinical trial presents significant challenges, particularly for emerging biotech companies with limited clinical experience, constrained patient populations, and the need to satisfy regulatory expectations. Phastar partnered with a biotechnology company developing an early-phase oncology program to design a robust dose-finding study that would […]

Demonstrating real-world value is critical for securing pricing and market access, but bridging the gap between clinical trial efficacy and real-world outcomes can be complex, particularly under HTA scrutiny. Download our case study to learn how advanced modelling and real-world evidence can quantify treatment impact, support pricing negotiations, and drive commercial success.  What You’ll Learn  […]

Biopharma organizations have access to vast amounts of real-world data, but extracting meaningful, actionable insights across multiple diseases and populations remains a major challenge. Traditional approaches are heavily manual, limiting scalability and slowing the ability to identify new opportunities.  Download our case study to learn how an AI-powered biometrics framework transforms real-world evidence into a […]

Demonstrating short-term efficacy is no longer enough, regulators increasingly require a clear understanding of long-term outcomes and benefit–risk balance. Translating Phase 3 trial data into long-term, real-world insights remains a major challenge, particularly when evaluating trade-offs between disease progression and treatment-related adverse events. Download our case study to learn how advanced modelling and simulation approaches […]

Understanding disease progression in complex, heterogeneous conditions like Huntington’s Disease is critical to designing successful clinical trials, but variability and small patient populations make this extremely challenging. Download our case study to learn how advanced data science and predictive modelling can uncover hidden patterns, improve patient stratification, and increase the probability of trial success.  What […]

How can pharmaceutical companies uncover new value from existing therapies without the cost and risk of developing new drugs from scratch? In this case study, discover how a leading pharmaceutical organization partnered with Phastar to apply AI and real-world evidence (RWE) to identify promising new indications for approved therapies in multiple sclerosis and related autoimmune […]

Augmenting Clinical Trials with Synthetic or Simulated Patients, Projecting Long-Term Benefit-Risk, and Developing Regulatory-Grade External Controls In our final session, we’ll explore how AI is revolutionizing clinical trials through predictive modeling and the use of synthetic and simulated patients. We’ll discuss digital twins, virtual cohort simulations, and how to integrate real-world evidence (RWE) into trial […]

Bayesian methods continue to gain momentum as an alternative approach to traditional clinical trial design, yet many organizations still have limited experience applying them, particularly when engaging with regulators. With multiple global agencies releasing further guidance in this area, it is useful to understand the current landscape of this trial area. In this webinar, we […]

Automate Programming and QC Processes, Accelerating Operations and Evidence Generation This session will explore AI’s role in automating critical tasks in drug development. We will showcase how AI-powered technologies have been used to automate programming QC, systematic literature reviews, and streamline the identification of trial centers and KOLs, while highlighting AI’s role across clinical workflows […]

Understanding cause and effect is often of interest when conducting research, but in practice it is rarely straightforward. Even seemingly simple questions can quickly become complicated once we consider the broader context in which data is generated.   Take a light-hearted example. Does ice cream cause happiness? At first glance, the relationship seems obvious. However, if we look a little closer another factor emerges: sunshine. Warmer, […]

Drug development in rare diseases requires the most efficient use of limited data, across both clinical trials and real-world settings. In this webinar, we will explore how combining predictive disease and care modeling with real-world data (RWD) can help translate efficacy observed in clinical trials into real-world effectiveness.  Using practical examples from rare disease settings, […]

To mark Clinical Trials Day 2026, Matt George, Senior Statistician, and Sam Hinsley, Statistics Manager at Phastar, highlight how statistical innovation is reshaping early-phase clinical trials in a comment for ACRP Clinical Researcher. They discuss the growing complexity introduced by early-phase combination trials, where traditional approaches can lead to overly conservative or unsafe dose recommendations. […]

About This Webinar In this session, we explore real-world use cases where AI and LLMs (Large Language Models) have been applied to explore large data sources such as omics, literature, and real-world data (RWD). We explore how AI can help identify optimal target populations, endpoints, and even support drug repurposing. Speaker: Billy Amzal, Ph.D.Head of […]

About This Webinar As expectations for robust, real-world evidence continue to grow, understanding how regulators evaluate causal analyses is becoming increasingly important. In this session, we will explore why causality matters, how agencies such as the FDA, EMA, and NICE are viewing causal inference, and what this means for study design and regulatory submissions. Speakers […]

This webinar will cover methods that are crucial to making informed decisions. Specifically, personalized care through causal and federated learning, targeted maximum likelihood estimation (TMLE) and doubly robust methods.   Speakers: Ryan Batten, Senior Statistician, Phastar Julie Joss, Senior Researcher, Inria Josh Enxing, Senior Programmer, Phastar- Moderator Learning Points: Distinguishing correlation from causation in the […]

Early-phase oncology combination trials often assume the optimal dose is already included in the dosing grid. When it isn’t, sponsors may face subtherapeutic or overly toxic recommendations, protocol amendments, and delays.  This white paper explores a contour-based method for inserting new dose combinations mid-trial, helping improve dose selection while maintaining safety and regulatory transparency.  What You’ll Learn  About the Author  Matt George, Senior Statistician, Phastar Specialist […]

Sam Hinsley, Statistics Manager at Phastar, shares practical insights into early phase clinical trial design in a new article for Biopharm International. The piece explores the evolving statistical approaches shaping modern drug development. She examines how Phase I trials are moving beyond the traditional focus on maximum tolerated dose (MTD) toward identifying optimal biological dose […]

Early-phase oncology trials are increasingly exploring combination therapies to improve outcomes for patients with complex cancers. While these approaches hold promise, they also introduce new methodological challenges, particularly when identifying the optimal dose combination that balances efficacy with acceptable toxicity.  In this blog, we explore how recent methodological research [1] from our statistical experts, Matt George and Ian Wadsworth, in collaboration with Pavel Mozgunov of the MRC Biostatistics Unit in Cambridge, applies […]

To mark International Women’s Day 2026, a new article in Applied Clinical Trials authored by Vicky Marriott, Head of Statistics at Phastar, explores why advancing gender equality in statistics and data science is essential for innovation, collaboration, and long-term industry growth. The article examines the barriers women continue to face across education and career progression […]

Billy Amzal, Head of Strategic Consulting at Phastar, and a Bayesian design expert and pioneer, explores the techniques used in Bayesian trial designs, examines regulatory updates, and shares real-world examples of the impact of these innovative methods in a new article for Applied Clinical Trials. “With rare disease a growing area of clinical research and […]

Phastar is sponsoring BBSW 2026, 5-6 November in Foster City, CA. Connect below to set-up a meeting or stop by Booth #2 to engage with our team. Schedule a meeting with us below:

Phastar is excited to be attending European Statistical Forum, 12 – 13 November in NH Budapest City, Budapest. Connect with us at our presentation or request a meeting below: Experiences of Utilizing the BOIN12 Method for Designing Rare/Small Population Oncology TrialsGiles Partington, Consultant Statistician13 November 2026 Schedule a time to meet below:

Phastar is exhibiting at the PSI Medical Statistics Careers Event at, 18 November Cutler’s Hall in Sheffield. Connect below to set-up a meeting or stop by our table to connect with our team. Schedule a meeting with us below:

Phastar is delighted to be exhibiting at PHUSE APAC Connect 2027, 28-30 January in Bengaluru, India. Visit the Phastar team at our exhibit or visit our posters and presentations to find out more about our solutions. Schedule a time to meet below:

Phastar is sponsoring SCOPE Summit 2027, 1-4 March in Orlando, FL Connect below to set-up a meeting or stop by Booth #427 to engage with our team. Schedule a meeting with us below:

On the 12th January  2026 the FDA brought out recommended guidance on the use of Bayesian methods, this marks the first time that the FDA has brought out draft guidance on Bayesian methods outside of brief mentions within other guidelines (such as the rare disease, adaptive designs and medical devices) where it is often regulated to a short paragraph or section. They are applicable to […]

Causal inference is increasingly used to generate real-world evidence (RWE), by regulatory bodies and health technology assessment. This webinar introduces what is required to support causal claims, how causality can be evaluated across different study designs, and why this shift is particularly relevant for RWE today.   Speakers: Ryan Batten, Senior Statistician Josh Enxing, Senior Programmer- Moderator Learning Points: Distinguishing correlation from causation in the context of clinical and […]

Statistics sit at the heart of every early-phase clinical trial. From dose escalation to determining the Maximum Tolerated Dose (MTD), statistical decisions guide how evidence is generated, interpreted, and acted upon. These choices influence patient safety, trial efficiency, and the likelihood of identifying the right dose to take forward.  In this blog, we explore some of the key statistical […]

Phastar partnered with a biotechnology sponsor to manage statistical and data management activities for a late-stage clinical study in Parkinson’s disease. The project involved distributed teams, complex neurosurgical procedures, and questionnaire-driven endpoints—all under tight budget oversight.  Key Challenges:  Our Approach:  Outcome:  The study progressed smoothly, earning strong praise from all stakeholders. The sponsor commended Phastar’s professionalism, attention […]

Designing an early-phase clinical trial is one of the most important, and most complex, steps in drug development. The choices made here determine how efficiently a program progresses, how robust the data will be, and ultimately, whether a promising treatment reaches patients.  In this blog, we explore where to begin when planning an early-phase study, […]

Decentralized clinical trials (DCTs) continue to gain momentum as sponsors look to reduce participant burden, improve diversity, and expand access to research. But with the benefits of remote participation come new statistical and operational challenges that must be addressed early in trial planning. A new article published in Clinical Research News explores key considerations for […]

As the pharmaceutical landscape evolves, traditional clinical trial designs are increasingly complemented by innovative, data-driven approaches. Real-world data (RWD) offers the potential to augment trials, simulate patient populations, and generate synthetic control arms. In-silico trials, powered by RWD and advanced analytics, help provide a path to faster, more efficient, and highly informative drug development. This […]

The early stages of clinical development are critical, and the decisions made here determine not only the efficiency and cost of a program but ultimately whether a promising compound reaches patients at all. As the therapeutic landscape evolves and the demand for innovative trial designs grows, early-phase studies have become an ever-changing and rapidly advancing […]

Discover how Phastar converted 16 legacy studies into SDTM and delivered a robust Integrated Summary of Safety (ISS) for a Multiple Sclerosis Spasticity program. Despite inconsistent legacy data, outdated coding, and complex integration requirements, Phastar applied structured methodology, proactive issue resolution, and harmonized integration to deliver clean, compliant, submission-ready datasets. Complete the form below to […]

Use of external data to augment clinical trials has been increasingly evaluated and is transforming drug development paradigms.   Numerous innovative methods including hybrid designs, Bayesian borrowing and disease modeling have been developed, raising the new regulatory question: “Is the data we observe similar to the data we predicted or intended to include?”    The […]

A sponsor needed to pool data from four MS spasticity studies—one still ongoing with another vendor—while adapting mid-project to a new SDTM-level pooling strategy. Unique baseline derivations, advanced analyses, and regulatory expectations added further complexity. SolutionPhastar introduced a modular workflow separating statistical analysis from TFL production. This streamlined process reduced run times, improved efficiency, and […]

The demand for rapid, cost-effective, and standards-compliant SDTM delivery continues to increase across the biotech and pharmaceutical industry. While company level SDTM standards and SAS macro-based solutions have fulfilled the needs for many years, they can still be restrictive and less adaptable in today’s evolving trial landscape and performance requirements.  This webinar series will discuss the practical […]

Phastar acted as the Independent Data Analysis Centre (IDAC) for a Phase III trial in thrombotic microangiopathy (TMA) after HSCT. With 13 DMC meetings, ad hoc analyses, and tight budget constraints, our team ensured secure data sharing, expert review, and streamlined workflows—delivering high-quality results while controlling costs. Download the full case study to explore the […]

As clinical trials grow increasingly complex, sponsors are turning to specialist CROs with the expertise to transform data into regulatory-grade evidence. In this article for The Medicine Maker, Stephen Corson, Associate Director of Statistics & Technical Solutions at Phastar, discusses how the CRO model is evolving, from transactional service delivery to strategic partnership, helping sponsors […]

In our “Meet the Team” series, we highlight the talented individuals who drive Phastar’s success. Each team member brings unique skills, experience, and passion to their role, working together to deliver high-quality biometrics and data science solutions in clinical research. Below, we share their career journey, insights, and the impact they make every day.  Can […]

The early stages of clinical development are critical, decisions made here can determine the efficiency, cost, and ultimate success of an entire program. With the evolving landscape of early phase drug development, sponsors need flexible yet robust statistical approaches to ensure that promising compounds are evaluated effectively and efficiently. Getting this stage right not only […]

Phastar supported a sponsor in preparing an Integrated Summary of Safety (ISS) for an investigational drug in sickle cell disease, pooling data from three studies: two Phase 3 randomized trials (single- and multiple-dose) and one open-label extension.  Key Challenges:  Our Approach: 

Interim analyses in Phase III trials are high-stakes and often come with evolving requirements and tight timelines. When frequent revisions and compressed schedules created additional challenges, Phastar partnered with the sponsor to deliver clarity, accuracy, and confidence.  Key challenges included:  Phastar’s tailored solutions:  Complete the form below to read the full case study

Navigating multi-therapeutic Phase III studies is complex. From strict blinding protocols to scheduling senior DMC members across multiple time zones, the challenges are significant. Phastar’s tailored approach ensures that every deliverable is managed efficiently, securely, and with the highest statistical rigor.  Key highlights from our case study:  Complete the form below to read the full […]

Real-world data (RWD) are transforming clinical research. By supplementing randomized controlled trials (RCTs), RWD can de-risk studies and improve generalizability. Innovative designs, from hybrid RCTs to registry-based trials, are gaining traction, with regulators setting clear standards for their use. This webinar shares case studies, practical methodologies, and key considerations to help you apply RWD effectively […]

Integrating efficacy and safety data across multiple studies is never simple—especially when patient-reported outcomes, complex study designs, and multiple safety populations are involved.  In this case study, see how Phastar partnered with a global sponsor to deliver both an Integrated Summary of Efficacy (ISE) and an Integrated Summary of Safety (ISS) for a treatment targeting […]

Data Monitoring Committees (DMC) are a critical part of the clinical trial process, independently assessing the safety of an investigational product and at times the futility/efficacy. Successfully navigating DMC set-up, logistics, and independent data review can be complex, especially for biotech and smaller sponsors without in-house expertise.  Speakers: Lucy Clark, Statistics Manager Lisa Gibbons, Senior […]

Phastar recently welcomed Billy Amzal as Head of Strategic Consulting. A statistician, public health scientist, and entrepreneur, Billy brings more than 25 years of experience across the biotech and pharmaceutical industries, health agencies, and consulting.  His expertise lies in innovative, regulatory-grade statistical methodologies including adaptive trial designs, model-based meta-analysis, Bayesian approaches, and predictive modeling using […]

Introduction  Randomized Controlled Trials (RCTs) remain the cornerstone of evidence generation in clinical research, providing rigorous and unbiased assessments of treatment efficacy and safety. The frequentist framework, which underpins most traditional trial designs, relies on predefined sample sizes and statistical significance thresholds. While effective for common conditions with large patient populations, these methods often face […]

If your clinical data review process feels slow, fragmented, or error-prone, this case study shows how Phastar and Beaconcure cut review cycle times by over 35%. Learn how a centralized platform can: Whether you’re a sponsor, CRO, or data manager, this is essential reading to modernize your review workflows and accelerate trial timelines. Complete the […]

In Giles Partington’s recent article for Pharmaceutical Outsourcing, the Phastar Principal Statistician explores how expert prior elicitation can enhance clinical research—particularly in areas with limited data, such as rare diseases and early-phase development. He outlines how this structured approach enables teams to formally incorporate expert opinion into Bayesian trial designs, supporting more efficient, relevant, and […]

Sponsors working in rare diseases/running small population studies often have difficulties in demonstrating efficacy due to the small number of patients available for analyses. Bayesian methods offer promising solutions for small population and rare disease trials where leveraging available data can provide important insights and evidence. Discover the importance of Bayesian trial designs and the […]

How Phastar Rescued 12 Studies and Became a Long-Term Strategic Partner. Discover how Phastar stepped in to rescue multiple high-stakes oncology trials following quality failures from a previous vendor — restoring data integrity, meeting tight regulatory deadlines, and delivering fully validated outputs. Download the full case study to explore the approach, outcomes, and lasting impact. […]

Real World Evidence (RWE) plays a critical role across multiple pharma processes, including drug development, regulatory decision-making, precision medicine and health economics, providing valuable insights from actual clinical practice. In order to leverage these data effectively and make informed decisions, sponsors need to be aware of the types of data that are available and the […]

Discover how Bayesian statistics can enhance clinical trial efficiency and improve decision-making. Our latest white paper, authored by Giles Partington, Consultant Statistician at Phastar, explores how Bayesian methods address key challenges in clinical research.  Key insights include: How Bayesian frameworks differ from traditional frequentist approaches The role of prior elicitation in enhancing trial design Practical […]

Introduction   Our webinar explored the use of expert prior elicitation techniques in clinical research, particularly in the context of Bayesian statistics. The event featured presentations from experts in the field, including Professor Thomas Jaki from the University of Regensburg and the University of Cambridge, Nigel Dallow from GSK, and statisticians from Phastar. Introduction to Prior […]

Early phase trials play a crucial role in drug development, determining the dose to test in later phases. With the rise of combination treatments, there is a growing need for innovative and efficient trial designs to navigate this complex landscape. Discover how new research is paving the way for more efficient and flexible strategies in […]

On Rare Disease Day, we highlight the potential of Bayesian statistics to overcome recruitment challenges in rare disease trials. In an article for ACRP Clinical Researcher, Giles Partington, Principal Statistician at Phastar, explores how incorporating prior data and expert judgment can reduce sample size requirements, improve efficiency, and increase trial success rates. ”There are between […]

Discover how Real-World Evidence (RWE) is revolutionizing drug development and clinical decision-making in our latest whitepaper.  What You’ll Learn:  Featuring a Real-World Case Study with AstraZeneca:  Explore how our partnership with AstraZeneca harnessed machine learning and RWE to transform treatment decision-making for non-small cell lung cancer (NSCLC).  This whitepaper is essential for clinical researchers, pharmaceutical […]

Understanding causal relationships in real-world data is challenging, particularly in observational studies, where confounding can introduce bias. If confounding is not properly accounted for, treatment effect estimates may be misleading, impacting decision-making. Therefore, correctly modelling confounding is essential for valid causal inferences. Two popular approaches to achieve this are inverse probability of treatment weighting (IPTW) […]

London, UK, and Durham (NC), US – February 13th, 2025: Phastar, a global specialist biometrics & data science contract research organization (CRO), won a Best of Show Award at Summit for Clinical Ops Executives (SCOPE) US 2025. Having taken place in Orlando, Florida from the 3rd-6th February, SCOPE’s 300+ attendees voted on more than 60 product […]

Introduction Integrating Real-World Data (RWD) and Real-World Evidence (RWE) into clinical research is gaining significant traction, due to the wide range of benefits it brings. However, integration of RWE into clinical research and trials can come with specific technical challenges such as handling unstructured data, standardizing data across multiple sources, and navigating regulatory and ethical […]

Real-world data (RWD) and real-world evidence (RWE) are transforming the clinical research landscape. During our recent webinar, Phastar’s experts explored the growing impact of RWD and RWE, highlighting their use in clinical trials, regulatory decision-making, and real-world applications. The session included presentations from Phastar’s expert statisticians and data scientists, offering practical insights into how these […]

London, UK, and Durham (NC), US – December 9th, 2024: Phastar, a global specialist biometrics contract research organization (CRO), has won the Best CRO – Specialist Providers category at the 2024 Scrip Awards. Presented at Raffles London at the OWO on Wednesday, December 4th, Phastar was recognized for its high-quality, specialized biometrics solutions, advanced clinical […]

Introduction  The EU Health Technology Assessment (HTA) is set to undergo significant transformation at the beginning of next year, with the upcoming joint clinical assessments (JCAs) aiming to streamline processes across member states. The new framework marks a substantial departure from the previous decentralized model of HTA in Europe.   This shift presents both opportunities and […]

Real World Evidence (RWE) is playing an important role in the drug development process by providing valuable insights from real world clinical practice. In order to leverage these data effectively and make informed decisions, sponsors need to be aware of the types of data that are available, and the challenges associated with using them, as […]

Since the introduction of Project Optimus by the FDA in 2020 [1], it has become more important than ever to ensure that oncology trials consider both efficacy and toxicity from the earliest phase. Similarly, it is key to consider ranges of doses that can be investigated at later stages. This means that rather than looking […]

Psoriasis is an inflammatory disease characterised by lesions on the skin and has a prevalence of around 2% in the global population. To date, a Phastar client has conducted three randomized placebo-controlled trials with their study drug, all achieving a p-value <0.001 demonstrating efficacy. There are a variety of methods to treat skin conditions that […]

With the upcoming introduction of the new EU HTA guidance in January 2025, sponsors in the pharmaceutical, Biotech and medical device sectors will face a significant regulatory shift. This change will demand the generation of a substantial body of evidence within stringent timelines. To help you prepare for this transition, we are hosting an informative […]

Introduction Project Optimus marks a major advancement in optimizing patient outcomes in oncology. By prioritizing dose optimization, this groundbreaking initiative aims to enhance the efficacy and safety of cancer treatments and improve drug development processes. However, implementing Project Optimus comes with its own set of challenges. This blog discusses the complexities of aligning clinical trial […]

Introduction With the launch of Project Optimus, the FDA is overhauling the paradigm of dose optimization and selection in oncology drug development. This initiative tackles the problem of poorly characterized doses and schedules, which can result in increased toxicity without enhancing efficacy.   This transformation will require substantial changes in the design and execution of early […]

Introduction The Project Optimus initiative is a key part of the U.S. Food and Drug Administration (FDA’s) Oncology Center of Excellence (OCE) and represents a shift in the agency’s approach to cancer treatment dosing. [1] The three main goals of Project Optimus are:  These goals are to ensure that more patients receive the appropriate dose […]

By Michael Willis, MSc, Senior Statistician, and Lisa Gibbons, MSc, Senior Statistician Introduction The landscape of clinical trials is changing, with sponsors looking for more ways to make trials quicker and more efficient, thus shortening drug development timelines and bringing important new treatments to patients faster. Innovations exist in the study set-up, recruitment, delivery, and […]

Introduction With the launch of Project Optimus, the FDA aims to reform the dose optimization and dose selection paradigm in oncology drug development. The initiative addresses the issue of poorly characterized doses and schedules, which can lead to increased toxicity without additional efficacy.   This transformation necessitates significant changes in how early phase trials are designed […]

By Wei Liu, PhD, Associate Director, Biostatistics, and Gillian Armstrong, MSc, Consultant Statistician The FDA recently published a draft guidance on the Use of Data Monitoring Committees (DMCs) in Clinical Trials for consultation. Leveraging our substantial expertise in DMCs, a select group of Phastar statisticians thoroughly reviewed and provided insightful comments on the guidance. By […]

‘Statistics and the interpretation of statistical results are an important part of what researchers do and how healthcare teams make decisions on how best to help their patients. To do so effectively, it is imperative that we ensure we all have clear lines of communication and effective collaboration.’ Stephen Corson, Associate Director, Statistics and Technical […]

Wei Liu, Associate Director of Statistics at Phastar, recently co-authored a manuscript published in the Journal of the National Cancer Institute. The study focuses on neurocognitive impairments in adult survivors of childhood cancer, aiming to identify common phenotypes and modifiable risk factors for personalized interventions. To read the full paper visit the Journal of the […]

Introduction An abundant problem in clinical trials is the absence of data due to patients prematurely withdrawing from trial participation. Censoring is a common characteristic in longitudinal trials that collect time to event data. Usual methods of analysis can be implemented if the data is assumed to be censored at random (CAR). However, if this […]

Giles Partington, Principal Statistician at Phastar, recently provided an article for Clinical Research News explaining the basis of Bayesian statistics and discussing the application of this approach, particularly within rare disease trials, along with the opportunities and challenges. Read the full article here: https://www.clinicalresearchnewsonline.com/news/2024/04/26/bayesian-statistics-an-important-yet-underutilized-paradigm-in-rare-disease-and-small-population-drug-development

London, UK and Durham (NC), US – 7th March 2024. Prof Jennifer Visser-Rogers, Vice President, Statistical Research and Consultancy at Phastar, has today been announced as one of the Women in Data® Twenty in Data & Technology. The 6th series is a showcase of inspirational, trailblazing and dedicated women, encompassing every level of seniority and data […]

Phastar is providing pro-bono support to Medicines Development for Global Health (MDGH) as part of its Phastar CARES scheme. Phastar’s biometrics experts supported the statistical analysis plan (SAP) updates for two related studies on the treatment of onchocerciasis. Study details MDGH, a not for profit biopharmaceutical organization developing medicines for neglected diseases primarily affecting people […]

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Professor Deborah Ashby, Interim Dean of the Faculty of Medicine, Imperial College, recently presented Phastar’s annual Sally Hollis Memorial Lecture. In this Q&A for Outsourcing Pharma, Professor Ashby and Professor Jennifer Visser-Rogers, Vice-President for Statistical Research and Consultancy at Phastar, discuss how new approaches to clinical trials are changing data monitoring committees. Read the full Q&A at Outsourcing-Pharma.com.

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Authors: Giles Partington, Sarah Simpson, Lauren Rojas, Emily Foreman, Ian Wadsworth. Bayesian statistics is one of the two main fields of thought for statistics. Whilst the more familiar frequentist statistics focuses on observing events to attempt to disprove a null hypothesis at a specific p-value and power; Bayesian statistics uses the ideas behind Bayes theorem […]

The European Medical Association (EMA) defines “rare diseases” as diseases that affect fewer than 5 in 10,000 people;[1] whereas small population trials are those looking at a specified subset of the population that are of interest within a trial, such as patients with a more common ailment but who cannot be maintained effectively by current […]

About this webinar The application of expert prior elicitation in clinical research serves as an important methodological tool to quantify expert knowledge into the definition of prior probability distributions, which can be leveraged to inform Bayesian study design, enhance decision making, and ultimately advance the quality of patient care. In this webinar recording, our panel […]

A great turnout of members from the Phastar family, together with guests from the wider community, gathered in Macclesfield for an evening of education, commemoration, and celebration at the third annual Sally Hollis Memorial Lecture event. This year’s lecture was delivered by Professor Deborah Ashby, Interim Dean of the Faculty of Medicine at Imperial College, […]

Author: Professor Deborah Ashby Interim Dean of the Faculty of Medicine, Imperial College London About the lecture  During a clinical trial, accruing data is often seen in confidence by a data monitoring committee to evaluate whether early termination of the study or other modifications are needed in the light of emerging results. For a classical […]

Authors: Giles Partington, Lindsay Govan, Paddy O’Hara, Emily Foreman, and Jennifer Visser-Rogers | Phastar Abstract A key challenge in drug development for rare disease is difficulty in obtaining relevant data due to a lack of suitable trial participants for each specific condition. Conservative estimates suggest there are 300 million people worldwide living with more than […]

Author: Stephen Corson | Phastar We are delighted to have made available two slideshow presentations given by Phastar’s Statistics Manager, Stephen Corson, to the statistics and data science community at DIA. Stephen’s presentations are closely related, covering the same material at differing layers of detail and complexity. Both cover key statistical methods, their appropriate applications, […]

There is always an excited buzz around one or two hot topics at statistics conferences, and PSI 2023 was no exception. Previously, it’s been estimands, or real world evidence. This year we were all talking about HTA. But what is it? And why the buzz now? According to the European Commission (EC), a health technology […]

Phastar’s Statistics Manager, Stephen Corson, has been chosen by the Board of Directors and the Fellows of DIA to receive the DIA 2023 Global Inspire Award for Community Engagement. This prestigious award recognises the outstanding contribution of the DIA Community Chairs who consistently drive engagement and promote knowledge sharing, while advancing thought leadership within the […]

COVID-19 and its subsequent variants have provided challenges in many ways, not the least of which are in the conduct and management of clinical trials. Global quarantines and disruptions in investigational product supply, patient recruitment and sustainability have been major concerns in an era when it’s more important than ever to proceed with drug development. […]

Presented by: Professor James Carpenter | MRC Clinical Trials Unit, LSHTM Complete the form below to watch the webinar

Hepatitis B virus (HBV) infection is among the most common persistent viral infections in humans. Chronic infection of HBV (CHB) can lead to serious medical complications such as cirrhosis, hepatocellular carcinoma, and liver failure. Surrogate markers are often used to monitor the progression of the disease and patients are treated with antiviral agents to reduce […]

A new formulation under investigation was planned to be submitted for use in both the US and Europe. As the reference formulation in the US differs from that in Europe, two separate bioequivalence studies were needed to gain approval from the FDA and EMA. Study 1 was conducted for FDA approval and successfully demonstrated bioequivalence. […]

Phastar was awarded as a preferred supplier to a top 20 pharmaceutical sponsor, supporting five new studies per year. Each study was several years in length, with IDMC meetings taking place every 3-6 months. Phastar worked with this pharmaceutical sponsor through two models for IDAC support; model one offering independent programming of the blinded and […]

Presented by: LaRee Tracy, PhD, and Joshua Baker, PhD Complete the form below to watch the webinar

Presented by: Lucy McParland | Phastar Complete the form below to watch the webinar

Phastar statistician Ian Wadsworth had a research article published in Statistical Methods in Medical Research examining modelling approaches for quantifying how exposure-response parameters vary over different ages in paediatric populations. Here he summarises the methodologies considered: Within paediatric populations, different age groups of children treated with a new medicine may experience differences in dose–exposure and […]

Phastar began a relationship with a top ten pharmaceutical company carrying out statistical consultancy and were subsequently asked to bid to be a partner in a traditional outsourcing model (i.e. the reporting of clinical trials is done independently by Phastar using Phastar systems and processes). An RFI/RFP process was undertaken, and we responded, giving details […]

Phastar has a number of sponsor relationships where we provide teams of statisticians and statistical programmers to complement the internal teams within medium and large pharma companies. For example, we provide a large integrated production team of statisticians and statistical programmers to a large global pharmaceutical company. The Phastar staff primarily work from our offices […]

A common question in clinical research is whether a new method of measurement is equivalent to an established one. As a statistical consultant at Phastar, I am seeing an increase in the number of trials where a new artificial intelligence or machine learning diagnostic tool is being compared to either a pre-existing tool, or to […]

At a conference, the results of a clinical trial demonstrate that a new medicine is efficacious and safe for a particular disease or condition. Patients, understandably, want to know when they will have access to this new treatment. Regulatory approval will be sought and individual countries will need to consider reimbursement. But, before we even […]

When developing a new medicine for children, the potential to extrapolate from adult efficacy data is well recognised. Extrapolation can be used to streamline drug development, with the European Medicines Agency (EMA) defining extrapolation as: “… extending information and conclusions available from studies in one or more subgroups of the patient population (source population) … […]

When designing a clinical trial, one of the biggest factors that needs to be thought about is blinding. In clinical trials, there is a risk of expectation influencing findings so if a patient knows which treatment group they have been allocated, there is a risk that this could bias results. In controlled trials, the term […]

Starting a career in industry can be a daunting experience at any time of life, but especially when it is your first full time job. Going from being a full-time student and enjoying the student life is very different to experiencing the 9-5 day job. From my time so far, I believe that the first […]

I am now one year into my graduate role at Phastar, and it has been one of the quickest years of my life. I joined Phastar after graduating from the University of Strathclyde with a Masters’ degree in Mathematics and Statistics. I sought a job where I would be challenged, and I was not going […]

There has been a growing emergence in the utilisation of basket studies and it’s not difficult to see why. Progress in genomics, tumour biology and statistics has led to advances in “precision oncology”. Cancers that were once viewed as homogeneous in terms of location and treatment strategy are now better understood to be increasingly heterogeneous […]

In medical research, information on the outcomes of a treatment may be available from a number of clinical studies with similar treatment protocols. When the studies are considered individually, they may be either too small or too limited in scope to come to a general conclusion about the effect of the treatment. Meta-analysis, defined as […]

Integration of data from a number of clinical trials for an Integrated Summary of Safety (ISS) and Efficacy (ISE) requires careful planning and includes the following planning steps [see ICH M4]: Assess the analysis and reporting requirements for the ISS/ISE Before starting integrating data across studies it is key to have a clear understanding of […]

A key objective of Phase I dose escalation trials is to establish a recommended dose and/or schedule for an experimental drug or combination for further testing in Phase II. They balance avoiding unnecessary exposure of patients to subtherapeutic doses with maintaining safety and rapid enrolment. Traditional “3+3” designs and their variations are simple to implement, […]

Recently, an FDA industry guidance draft on “Multiple Endpoints in Clinical Trials”1 provided an overview of multiplicity which is a controversial topic. This is due to the practitioner’s common lack of clarity on when and how it arises and what adjustments to implement, such that the number of false positives, i.e. the type I error […]

The public consultation period for the ICH E9 (R1) addendum on estimands and sensitivity analyses to the guideline on statistical principles for confirmatory clinical trials closed at the end of February 2018, and the addendum is planned to be issued in mid-2019. At first glance the draft addendum can appear quite confusing – with a […]

A rare disease is defined by the European Union as one that affects less than 5 in 10,000 of the general population and in the US, the definition is one that affects less than 200,000 persons1. There are between 6,000 and 8,000 known rare diseases and around five new rare diseases are described in medical […]

A key issue in assessing the efficacy of new drugs in oncology is getting the balance right between choosing a hard endpoint survival – and an endpoint that allows evidence to be assessed more quickly progression. Often discussions such as these are required after interactions with regulatory agencies. Progression free survival is used in many […]