Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.
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June 9, 2023
Maximizing Study Momentum: A Case Study in Accelerated DMC Safety Report Creation through IDMC Solutions
In the ever-evolving landscape of clinical development, the need for robust evaluation of interim clinical data through...
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June 7, 2023
A Spotlight on FSP Programming
Since its founding in 1987, Cytel has been home to some of the most passionate, creative, and talented experts in the...
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January 25, 2023
Bayesian Approach in Oncology Trials
People think in Bayesian terms all the time: we use prior information and the evidence at hand to make decisions in our...
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December 6, 2022
Career Perspectives: A Conversation with Veronica Chan
In this edition of the Career Perspectives series, I spoke with Veronica Chan, Principal Clinical Data Manager at...
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November 9, 2022
Career Perspectives: A Conversation with Malte Stein
In this edition of the Career Perspectives series, I interview Malte Stein, Senior Biostatistician. Malte owned the...
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October 14, 2022
Career Perspectives: A Conversation with Nicolas Rouillé
In this edition of the Career Perspectives series, I interview Nicolas Rouillé, Senior Director, Statistical...
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August 4, 2022
Interview with Allison Luccock about career perspectives
In this edition of the Career Perspectives series, I interview Allison Luccock, Director of Business Operations for...
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June 13, 2022
Driving Global Data Collaboration for COVID-19
The International COVID-19 Data Alliance (ICODA) was formed to address the challenge of generating rapid and rigorous...
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June 6, 2022
The TOGETHER Trial Journey: Interview with Ofir Harari
The award-winning TOGETHER Trial was designed with the vision of ensuring that COVID-19 therapies are both effective...
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May 31, 2022
What it means to be a lead analyst on a Global COVID-19 Trial
The TOGETHER Trial for COVID-19 therapies, designed by clinical trial specialists at Cytel won the Society for Clinical...
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May 24, 2022
Leveraging Advanced Statistical Software to Optimize Clinical Development
Traditionally, clinical trials are expensive, long in duration, and have low success rate. But with the advent of rich...
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May 12, 2022
Estimator Choice in Synthetic Control Arm Analyses
Synthetic control arm (SCA) methods are statistical methods that are seeing rapidly increasing use in comparative...
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May 5, 2022
Interview with Grammati Sarri on Moderating an Issue Panel 2022
While randomized control trials remain the industry gold-standard for regulatory and reimbursement submissions, there...
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May 4, 2022
Optimizing Human-Machine Partnership for Up-To-Date Evidence
If you are a pharmaceutical or biotech company seeking to enter the market with a new drug, you need to submit a...
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April 29, 2022
An Interview with Gabriel Tremblay on his Poster Contributions to ISPOR US 2022
At ISPOR US 2022, Cytel’s HEOR & RWE experts will be contributing to a range of Issue Panels, In-person Podium...
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April 21, 2022
Bayesian Statistics and Its Applications: New Webinar by Professor Yuan Ji
Sophisticated Bayesian Methods are gaining a lot of traction as they bring flexibility and speed to clinical trial...
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April 13, 2022
Join Cytel’s HEOR Consultants at ISPOR US 2022
The Life Sciences landscape has seen an impactful digital evolution in the past two years. The pandemic has accelerated...
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April 12, 2022
Career Perspectives: Interview with Charles Warne, Associate Director of Biostatistics
In this edition of the Career Perspectives series, I interview Charles Warne, Associate Director of Biostatistics at...
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February 9, 2022
How can an optimized data strategy support your clinical program?
Data is the cornerstone of any clinical trial and is used to ultimately drive the decision-making process related to...
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January 26, 2022
Career Perspectives: Interview with Jessica Bhoyroo, Clinical Data Manager
In this edition of the Career Perspectives series, I interview Jessica Bhoyroo, Cytel Clinical Data Manager based in...
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January 20, 2022
Is Borrowing Outcomes from US or China the Future for Rare Conditions?
Limited patient populations resulting in small study sample sizes is a difficulty associated with the development of...
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December 20, 2021
Approaches in Adaptive Group Sequential Clinical Trials
The promising zone design is an adaptive design which allows for sample size re-estimation based on the results of an...
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December 8, 2021
Conditional Powers Vs Bayesian Predictive Power for Adaptive Sample Size Reassessment
Despite the debate in the scientific community on adaptive sample size reassessment (SSR), noteworthy developments have...
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December 7, 2021
Anna Forsythe on Aligning Clinical Strategy with Regulatory and Market Objectives
Sponsors bringing a successful new product to market have to overcome two hurdles: submission and reimbursement. For...
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November 30, 2021
Dr. Julia Edwards Findings Promising Zone Designs
The aim of any clinical research is to detect the actual difference in treatment effect between two groups (power) and...
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November 23, 2021
Using Single Arm Trials for HTA Submissions: Dr. Heeg and Maria Rizzo
A randomized clinical trial (RCT) is the gold standard approach to demonstrate the efficacy and safety of novel...
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November 17, 2021
Using Tech to align Regulatory and Market Access Evidence strategies
Traditionally, the teams responsible for clinical development and regulatory submissions do not consult the market...
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November 11, 2021
Championing RWE & HEOR at Virtual ISPOR Europe 2021
The value of Real World Evidence (RWE) is well known to many stakeholders, but its full potential for market access and...
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November 10, 2021
Evolving the Study Design Process: An ACT Webcast by Dr. Yannis Jemiai
There are many reasons why traditional approaches to designing a clinical study are generally suboptimal and do not...
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November 4, 2021
Join Cytel for HEOR Insights at ISPOR Europe 2021
The prominent European conference for Health Economics and Outcomes Research (HEOR), ISPOR Europe 2021, is around the...
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November 2, 2021
Empowering Trial Selection: An ACT Webcast by Dr. Yannis Jemiai
A good clinical study design performs well not only under the ideal target scenario. Statisticians should be able to...
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October 29, 2021
Designing Platform Trials
A platform trial, a type of Master Protocol, is an experimental infrastructure to evaluate multiple treatments and/or...
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October 27, 2021
Leveraging Staged Investment Strategy for Funding Novel Therapies
A staged investment strategy aligns R&D decisions and financial planning with the interim looks of a clinical trial. If...
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October 22, 2021
The Benefits of Using Basket Studies in Oncology
Currently, there are many treatment options for Cancer such as, Immunotherapy, Radiation Therapy, Chemotherapy etc. If...
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October 20, 2021
Strategic Clinical Trial Design Unlocks Innovative Opportunity
For health innovators, trial selection is a key success factor as there are no second chances. But how do you find the...
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October 15, 2021
Applications of Master Protocols in a Global Health Context
Almost 3000 registered trials were performed in COVID-19 and a majority of them have been small and likely...
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October 6, 2021
The Rapidly Evolving Need for Master Protocols
Master Protocols are advanced and innovative clinical trial designs that can evaluate multiple therapies and disease...
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October 1, 2021
Dr. Kyle Wathen talks about the Need for Statistical Innovation
The COVID-19 pandemic elevated the challenge of designing and executing clinical trials within a substantially...
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September 24, 2021
ICT Magazine Interviews Dr. Yannis Jemiai on the Benefits of Bayesian
We may be familiar with adaptive designs, but their complexity has made them difficult to implement and their benefits...
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September 14, 2021
Career Perspectives: Interview with Alyssa Biller, Senior Solutions Consultant
Alyssa Biller is a Senior Solutions Consultant at Cytel and currently plays a primary role in onboarding customers for...
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August 20, 2021
Using Causal Inference for Decision Making
In clinical research, decision makers need to choose among different courses of action every day. Whether it is...
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August 13, 2021
Finding the Optimal Trial Design Using Operations Research Methods
With the cloud computing power that we have today, we can run simulation of 1000s of designs with each design...
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August 5, 2021
Establishing the Comparative effectiveness and Safety of New Treatments Using Real World Data
It is important to compare competing interventions to determine value of medicines, both from clinical and societal...
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July 21, 2021
Bayesian Approach to Benefit-Risk Assessment
Conducting a transparent, targeted and robust benefit-risk assessment of a new drug or product is one of the most...
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July 20, 2021
Career Perspectives: Interview with Anil Golla, Vice President, FSP
Anil Golla is Vice President, Functional Service Provision (FSP) at Cytel. After 17 years of working at pharmaceutical...
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July 1, 2021
Myths surrounding the use of synthetic control arms in clinical trials: Part 4
Synthetic control arms (SCAs) are best suited for situations when a single arm trial is run in a patient population...
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June 25, 2021
Leveraging External Data for Efficient Trial Designs
The main challenge associated with the development of therapies for rare diseases is typically the small study sample...
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June 24, 2021
Myths surrounding the use of synthetic control arms in clinical trials: Part 3
Synthetic control arms (SCAs) leverage real world data from various sources or evaluations of historical clinical data...
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June 17, 2021
Myths surrounding the use of synthetic control arms in clinical trials: Part 2
In Part 2 of this four-part blog series, we bust another myth surrounding synthetic control arms (SCAs) used in...
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June 14, 2021
Practicalities of Integrating Electronic Health Records into Data
ACDM’s (Association for Clinical Data Management) eDigital data management expert group (DMEG) focuses on driving...
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June 10, 2021
Myths surrounding the use of synthetic control arms in clinical trials: Part 1
Over the past decade, single arm trials have emerged as an accepted way of assessing a new treatment intervention....
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June 4, 2021
Bayesian Methods: Paving the path to Clinical Development Transformation
Bayesian methods have been playing a key role in transforming clinical research in therapeutic areas such as oncology...
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June 3, 2021
Information Borrowing in Basket Trials
Bayesian methods allow for the incorporation of prior knowledge, in terms of either expert opinion from clinicians or...
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May 21, 2021
Use of Bayesian Analysis in Platform Trials: Webinar by Dr. Kyle Wathen
Most of us are familiar with the concept of platform clinical trials as they have gained popularity in the recent...
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May 7, 2021
Never Miss the Optimal Study Design Options
When is a study design considered to be optimal? A good design performs well not only under the ideal target scenario...
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May 5, 2021
Meet our Global HEOR and RWE Experts: Virtual ISPOR 2021
Cytel’s team of HEOR and RWE experts are all set to make a splash at the Virtual ISPOR on May 17 - 20. Our global...
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April 21, 2021
Understanding Head-to-Head Clinical Trials
Two therapies are placed in head-to-head clinical trials when they are compared against each other as opposed to a...
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April 14, 2021
Reaping the Benefits of Bayesian Innovation
In the era of modern clinical development, several companies are turning towards novel and innovative approaches such...
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April 13, 2021
7 Steps to an Evidence Dossier for Wearables
There has been an increasing use of digital measures in drug development recently. New wearables technologies can help...
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April 7, 2021
Career Perspectives: Interview with Neha Sati
Scientists at Cytel recently published a paper in the Journal of the American Medical Association (JAMA). Among the...
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September 12, 2019
Digital transformation in healthcare and drug development
"If you went to bed last night as an industrial company, you're going to wake up today as a software and analytics...
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