Perspectives on Enquiry & Evidence

Last week, we featured our final Winter Weekend Read, the last in a series designed to showcase our complimentary..

One of the lesser-known complications associated with Multiple Sclerosis is a higher risk of serious infections (SIs)...

Smaller clinical trials can be optimized in significant ways using simulation-guided design. A small biotech studying..

Many industries have long since adopted the practice of modeling and simulating experimental scenarios. And despite..

Real-world data has been increasingly used to answer questions related to the course, prognosis, and treatment of..

Grammati Sarri was recently interviewed by Inside Precision Medicine for “Improving Health Equity Starts with..

The speed of scientific discovery has been outpacing the ability of researchers to accumulate and integrate constantly..

Last week, Cytel Director & Research Principal Louis Dron discussed new FDA guidance on the design and conduct of..

Simulation-guided design is quickly becoming a novel feature of modern drug development. Its foundational promise is to..

The U.S. FDA has recently provided specific guidance[i] on the design and conduct of trials incorporating an external..

Those familiar with simulation-guided design (SGD) know that it can be used for a wealth of clinical trial options:..

Over the past years, probably the entire last decade, there have been several discussions on how to handle multiple..

For clinical development and research and development teams, the Pareto Frontier can perform two functions. Let’s take..

Asthma affects more than 235 million people worldwide, and due to lacking effective implementation of clinical..

Should your clinical trial be adaptive? Trials that include a prospectively planned modification based on an interim..

People think in Bayesian terms all the time: we use prior information and the evidence at hand to make decisions in our..

Ever since the first immune checkpoint inhibitor was approved for market nearly twelve years ago, the industry has..

A small biotech’s conventional carcinoma trial design was too expensive to implement and did not offer the opportunity..

When it comes to rare diseases, a handful of major challenges to drug development arise. Bayesians strategies have..

Bayesian methods, with their ability to facilitate flexibility and learning, are often associated with early-phase..

Statistical methods have long been fundamental to drug development, and advancements in the last few decades in..

You may have heard that our clinical trial strategy platform Solara® won the Fierce Life Sciences award for Technology..

  Returning to Cytel after the winter holidays, I am excited to begin a year that will likely prove memorable for both..

Perspectives on Enquiry and Evidence explores a wide variety of topics within clinical trial design and data science in..

Bayesian methods have been playing a key role in transforming clinical research, providing a variety of new..

Perspectives on Enquiry and Evidence features two recurring interview series: Our new Industry Voices series, in which..

Adaptive trial designs – that is, trials that include a prospectively planned modification based on an interim analysis..

Bayesian methods have been playing a key role in transforming clinical research, and Bayesian topics are frequently..

When evaluating the efficacy of a candidate investigational therapy, a standard clinical trial paradigm is to conduct a..

As promised in my last post prior to PHUSE-EU Connect, I’d like to now share some reflections on my “Integration..

In this edition of the Career Perspectives series, I spoke with Veronica Chan, Principal Clinical Data Manager at..

For 35 years, Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to..

Bayesian methods have continuously played a key role in transforming clinical research in therapeutic areas such as..

In the following interview, Dr. Parvin Fardipour, Quantitative Strategies & Data Science, sits down with Heather..

When conducting network meta-analysis (NMA) – that is, a technique that involves comparing multiple treatments..

In this edition of the Career Perspectives series, I interview Malte Stein, Senior Biostatistician. Malte owned the..

Although many of you can’t wait for the start of the Football World Cup 2022 (less than two weeks while I’m writing),..

Cytel will be represented at over 60 presentations at ISPOR Europe 2022, with more issue panels and workshops than any..

Pharmaceutical research in oncology is increasingly focused on the development of therapies targeted at newly..

Integrating the “pressure testing” of clinical trial designs into the process of creating a strong clinical trial..

On the occasion of Cytel’s 35th anniversary, co-founder Professor Cyrus Mehta sits down with Dr. Esha Senchaudhuri to..

 

On the occasion of Cytel’s 35th anniversary, co-founder Professor Nitin Patel sits down with Dr. Esha Senchaudhuri to..

In this edition of the Career Perspectives series, I interview Nicolas Rouillé, Senior Director, Statistical..

ISPOR Europe, the leading global conference for health economics and outcomes research (HEOR) and real-world evidence..

On the occasion of Cytel’s 35th anniversary, our CEO Joshua Schultz sits down with Dr. Esha Senchaudhuri to discuss the..

Master protocols and platform clinical trials have become an innovative and efficient approach to testing multiple..

Integrated Nested Laplacian Approximations (or INLA) are now starting to be used by statisticians as a key tool for..

The wider availability of electronic health data, medical registries, and even larger proprietary datasets means that..

The landscape of drug development has changed dramatically over the last few decades, and effective statistical leaders..

On Louis Dron et al., “Data Capture and Sharing in the COVID-19 Pandemic: A Cause for Concern,” The Lancet 4 (10) (2022)

Adaptive trial designs – that is, trials that include a prospectively planned modification based on an interim analysis..

In the first part of this article, I raised awareness of the availability of additional FDA guidances containing CDISC..

On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022, which includes U.S. drug..

In clinical trials, patient enrollment is often staggered, with data collected sequentially. When designing a clinical..

A new trend has emerged over the last decade that has changed the way many clinical trials are conducted. Unlike..

The American Statistical Association Biopharmaceutical Section, in cooperation with the FDA Statistical Association,..

Last week, we featured our final Summer Weekend Read, the last in a series designed to showcase some of our most recent..

Many thanks to Kyle Wathen and Behnam Sharif for their input on this post.

To continue our Summer Weekend Reads series, Cytel presents “Discover the Value of an Optimized Clinical Data Strategy”..

The International Society for Pharmacoepidemiology is hosting its “ICPE 2022: Advancing Pharmacoepidemiology and..

The American Statistical Association’s annual Joint Statistical Meeting (JSM) gathered over 6,500 attendees from 52..

 

In this edition of the Career Perspectives series, I interview Allison Luccock, Director of Business Operations for..

A number of late-phase clinical trial sponsors remain hesitant to employ Bayesian approaches in confirmatory settings,..

When new treatments are compared with existing therapies in clinical care, population-adjustment techniques need to..

Written by Jing Ping Yeo and Charles Warne Adaptive designs are studies that “include a prospectively planned..

To watch this webinar and others from this introductory series, click the link below.   The ability to draw on..

When performing indirect treatment comparisons, effect modification can create complexities in the event of high..

Many thanks to Grammati Sarri and Michael Groff for their comments in developing this blog.   An indirect treatment..

Thanks to Dr. Kyle Wathen for comments on this blog. The increasing use of platform trials for the testing of a wide..

The gold standard for assessing the efficacy for a medicine continues to be RCTs, however, for many reasons (disease..

How can we build an efficient statistical protocol for a clinical trial, if we do not know the therapies that will be..

Founded in 1987 by Cyrus Mehta and Nitin Patel, research scientists at Harvard University and MIT respectively and..

It can be difficult to estimate just how much time and data you need to address the multitude of considerations that..

For years CDISC data standards implementers have struggled to find good implementation examples and use cases beside..

Suppose you had to choose six clinical trials intended for registration with regulatory agencies, only six, to explain..

The International COVID-19 Data Alliance (ICODA) was formed to address the challenge of generating rapid and rigorous..

Clinical researchers, seeking to understand the statistical benefits of a common Phase 2 oncology design, now have a..

In most instances of blinded sample size re-estimation, the timing of the interim analysis that determines whether the..

The award-winning TOGETHER Trial was designed with the vision of ensuring that COVID-19 therapies are both effective..

How can clinicians at the forefront of modern clinical trials and statisticians at the forefront of advanced..

The TOGETHER Trial for COVID-19 therapies, designed by clinical trial specialists at Cytel won the Society for Clinical..

When submitting systematic literature reviews to a Health Technology Assessment authority, high volumes of research..

When constructing estimands a key question that arises is how to handle intercurrent events and missing data. In a..

Traditionally, clinical trials are expensive, long in duration, and have low success rate. But with the advent of rich..

Early in the pandemic, it became clear that many of the COVID-19 therapies being tested in wealthier nations, were not..

A combination of industry and policy forces have recently changed the shape of Australia’s R&D sector, making it a..

Synthetic control arm (SCA) methods are statistical methods that are seeing rapidly increasing use in comparative..

While randomized control trials remain the industry gold-standard for regulatory and reimbursement submissions, there..

If you are a pharmaceutical or biotech company seeking to enter the market with a new drug, you need to submit a..

In 2005, Pfizer launched a Phase 1 trial for the kinase inhibitor crizotinib. Six years later, it was approved, thanks..

At ISPOR US 2022, Cytel’s HEOR & RWE experts will be contributing to a range of Issue Panels, In-person Podium..

New medicines and devices under development live and die on the strength of their clinical data. An asset’s journey is..

I am excited to see you all at the CDISC Europe Interchange, April 27 – 28 but unfortunately, it will be a virtual..

This past decade has undoubtedly witnessed an increase in the number of single arm trials submitted to HTA bodies...

Sophisticated Bayesian Methods are gaining a lot of traction as they bring flexibility and speed to clinical trial..

The Life Sciences landscape has seen an impactful digital evolution in the past two years. The pandemic has accelerated..

In this edition of the Career Perspectives series, I interview Charles Warne, Associate Director of Biostatistics at..

The planning and optimization of a clinical trial is beset by uncertainties: knowledge of treatment effects, the..

Randomized control trials (RCTs) are the gold standard for estimating the efficacy of a treatment. They allow us to..

Hello! I’m delighted to pen my inaugural blog post here as Cytel’s Chief Medical Officer. In this series, we’ll explore..

At the end of every year, scientists from across Cytel’s business units are nominated for Cytel’s Spotlight Awards,..

For over a decade, the number one reason cited for trial discontinuity has been challenges associated with recruitment..

Real world evidence (RWE) provides a large and growing source of insights into drug uptake and safety. It is..

Every year, sponsors hesitating to use a complex innovative clinical trial design routinely miss opportunities to..

The issue of delayed treatment effects in immuno-oncology was demonstrated during a FDA-Industry sponsored workshop..

When determining the best possible statistical design for a particular trial, large pharmaceuticals and small biotechs..

Data is the most crucial asset of any clinical trial and hence, sponsors cannot jeopardize collecting clean..

It is a common perception that the role of a Data Manager is only to perform what we call “Data Cleaning”; making sure..

As the use of advanced and innovative clinical trial designs continue to rise, sponsors often wonder which estimation..

Adopting data standards such as CDISC in the early phase of clinical drug development contributes to the consolidation..

Data is the cornerstone of any clinical trial and is used to ultimately drive the decision-making process related to..

The ability to conduct data-driven and quantitatively rigorous feasibility studies, is often key to successful trial..

For nearly ten years, suboptimal trial enrollment has been cited as a primary cause of clinical trial discontinuation...

As a part of Cytel’s 10 Year Anniversary of the Promising Zone Design, Cytel hosted a quiz on “Keeping the Promise” –..

In this edition of the Career Perspectives series, I interview Jessica Bhoyroo, Cytel Clinical Data Manager based in..

In this blog, I share some experiences we recently had during an FDA submission Cytel performed for a sponsor after..

For our first Winter Weekend Read, Cytel presents How to Use and Interpret the Results of a Platform Trial, a JAMA..

Limited patient populations resulting in small study sample sizes is a difficulty associated with the development of..

The past two years have been transformative for Cytel. Most notably, the global COVID-19 pandemic unleashed an..

Cytel blogs bring you debate and discussion of the newest trends in statistics and quantitative strategy. In 2021, our..

The promising zone design is an adaptive design which allows for sample size re-estimation based on the results of an..

Recently, on November 29 I received an email from CDISC announcing an important update for both SDTM and ADaM CDISC..

In traditional clinical trial design, the sample size is often determined to detect the target treatment effect with..

Despite the debate in the scientific community on adaptive sample size reassessment (SSR), noteworthy developments have..

Sponsors bringing a successful new product to market have to overcome two hurdles: submission and reimbursement. For..

The FDA “Real-Time Oncology Review (RTOR)”[1] is an “FDA project started in 2018 to facilitate earlier submission of..

The aim of any clinical research is to detect the actual difference in treatment effect between two groups (power) and..

A randomized clinical trial (RCT) is the gold standard approach to demonstrate the efficacy and safety of novel..

Traditionally, the teams responsible for clinical development and regulatory submissions do not consult the market..

Since its first publication ten years ago, Cyrus Mehta and Stuart Pocock’s Promising Zone Design for sample size..

The value of Real World Evidence (RWE) is well known to many stakeholders, but its full potential for market access and..

There are many reasons why traditional approaches to designing a clinical study are generally suboptimal and do not..

Ten years ago Cytel co-founder Professor Cyrus Mehta and Professor Stuart Pocock of the London School of Hygiene and..

The prominent European conference for Health Economics and Outcomes Research (HEOR), ISPOR Europe 2021, is around the..

A good clinical study design performs well not only under the ideal target scenario. Statisticians should be able to..

A platform trial, a type of Master Protocol, is an experimental infrastructure to evaluate multiple treatments and/or..

A staged investment strategy aligns R&D decisions and financial planning with the interim looks of a clinical trial. If..

Currently, there are many treatment options for Cancer such as, Immunotherapy, Radiation Therapy, Chemotherapy etc. If..

A number of methods currently exist to measure non-adherence and non-persistence of medical therapies, for improved..

For health innovators, trial selection is a key success factor as there are no second chances. But how do you find the..

Almost 3000 registered trials were performed in COVID-19 and a majority of them have been small and likely..

When choosing the optimal clinical trial design for a given study, sponsors face critical questions like choice of..

‘Drugs do not work in patients who do not take them,’ said former surgeon general C. Everett Koop. Unfortunately, the..

Master Protocols are advanced and innovative clinical trial designs that can evaluate multiple therapies and disease..

Traceability is crucial in all steps of clinical data handling, from data collection to final analysis. The importance..

The COVID-19 pandemic elevated the challenge of designing and executing clinical trials within a substantially..

A complex methodological issue which arises in the production of real-world evidence involves the degree to which..

While there is a plethora of rare diseases, some 7000 diseases and counting, one needs to consider the statutory..

We may be familiar with adaptive designs, but their complexity has made them difficult to implement and their benefits..

A complex methodological issue which arises in the production of real-world evidence involves the degree to which..

Earlier this summer, we published a series of articles on the need to utilize weighting and prioritization tools in the..

There is recognized heterogeneity within any given tumor‐type from patient to patient (inter‐patient heterogeneity),..

Alyssa Biller is a Senior Solutions Consultant at Cytel and currently plays a primary role in onboarding customers for..

A key decision in the design of clinical trials in oncology involves whether to select progression free survival (PFS)..

For years, I have been telling the recruiters at Cytel to be wary of candidates claiming to have a CDISC Certification..

In clinical research, decision makers need to choose among different courses of action every day. Whether it is..

During the design of a clinical trial, many biotechs want to substantially reduce the risk of a good new therapy being..

With the cloud computing power that we have today, we can run simulation of 1000s of designs with each design..

A few weeks ago I wrote about new research conducted by Cytel statisticians, on the challenge of conducting..

Recently we discussed examining clinical development through a Bayesian lens, in honor of Cytel co-founder Nitin Patel..

It is important to compare competing interventions to determine value of medicines, both from clinical and societal..

I had recently (for the first time) the pleasure and honor to attend a virtual meeting with the FDA, a pre-NDA Type-B..

“We found an optimal design in hours that might have taken months to find using standard methods,” reflected Fabien..

Program and portfolio optimization creates a framework throughout the course of the clinical development journey, that..

Earlier this year, Cytel founder Cyrus Mehta observed that clinical trial design is often treated like an art rather..

Conducting a transparent, targeted and robust benefit-risk assessment of a new drug or product is one of the most..

Anil Golla is Vice President, Functional Service Provision (FSP) at Cytel. After 17 years of working at pharmaceutical..

For decades, statisticians have cultivated methods to optimize and de-risk clinical trials for strong regulatory..

Medical researchers and public health experts are becoming more reliant on meta-analyses to capture in summary form,..

Suppose a statistician were to tell a clinical trial sponsor that it was possible to improve the power of the sponsor’s..

Popular statistical designs, such as CRM (O’Quigley et al., 1990), mTPI-2 (Guo et al., 2017), and i3+3 (Liu et al.,..

Synthetic control arms (SCAs) are best suited for situations when a single arm trial is run in a patient population..

When Cyrus Mehta introduced the Promising Zone Design over a decade ago, the new statistical method not only..

The main challenge associated with the development of therapies for rare diseases is typically the small study sample..

Synthetic control arms (SCAs) leverage real world data from various sources or evaluations of historical clinical data..

Much of the discussion about clinical trial design considers methods to optimize performance characteristics and..

Next week’s PSI Conference will feature Dr. Yannis Jemiai speaking on the use of Scoring Functions in the re-imagined..

In Part 2 of this four-part blog series, we bust another myth surrounding synthetic control arms (SCAs) used in..

Ten years ago, a seminal paper published by Cytel Founder Cyrus Mehta, introduced the Promising Zone Design to..

ACDM’s (Association for Clinical Data Management) eDigital data management expert group (DMEG) focuses on driving..

Over the past decade, single arm trials have emerged as an accepted way of assessing a new treatment intervention...

When selecting clinical trial designs, how many design options should a sponsor explore? Would a sponsor feel more..

Bayesian methods have been playing a key role in transforming clinical research in therapeutic areas such as oncology..

Bayesian methods allow for the incorporation of prior knowledge, in terms of either expert opinion from clinicians or..

For many decades the Pareto Frontier has been employed by actors in the private sector to evaluate and understand the..

Advancements in biomarkers and momentum in precision medicine has paved the foundation for complex studies like basket..

Most of us are familiar with the concept of platform clinical trials as they have gained popularity in the recent..

As more payers and HTA agencies turn to real world data to compare the effectiveness of various treatment effects, two..

Clinical trial sponsors are more likely than ever to use the power of simulation and forecasting to evaluate the..