
Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.

May 22, 2023
By Grammati Sarri, Evie Merinopoulou, Vinusha Kalatharan, and Jason Simeone The Canadian Agency for Drugs and..
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May 10, 2023
FDA Increases Calls for Manufacturers to Ensure Trial Diversity, but Does It Fall Short of Addressing Health Inequalities in Product Development?
The evidence is staggering on the unequal health burdens experienced by specific patient groups defined by ethnic,..
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May 3, 2023
Reflections on the RCT DUPLICATE Study and Increasing Confidence in Real-World Evidence
With input by Alind Gupta, Louis Dron, and Jason Simeone. Randomized clinical trials (RCTs) have long been considered..
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April 25, 2023
How Target Trial Emulation Can Take the Guesswork Out of Comparative Effect Estimates in Medicare Drug Price Negotiation
An interview with Miguel Hernán, Harvard University Kolokotrones Professor of Biostatistics and Epidemiology On March..
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April 18, 2023
Navigating Comparative Effectiveness in the Inflation Reduction Act: Methodological Approaches for Healthcare Challenges
The Inflation Reduction Act (IRA), passed in August 2022, marks a significant shift in the US healthcare landscape,..
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April 14, 2023
Data Challenges (and Solutions) for Externally Controlled Trials
Real-world data and evidence are increasingly being used in health care decisions and publications. However, there are..
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April 11, 2023
Overcoming the Shared Effect Modifier Assumption with Network Meta-Interpolation
Commonly used methods to handle the complexities of effect modification in indirect treatment comparisons (ITCs) often..
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April 5, 2023
Comparative Effectiveness: Methods and Techniques for Better Decision-Making
Health technology assessment (HTA) submissions require cost effectiveness analyses based on comparative effectiveness..
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March 21, 2023
Retrospective Claims Data Analysis Unlocks Discovery in Multiple Sclerosis Research
One of the lesser-known complications associated with Multiple Sclerosis is a higher risk of serious infections (SIs)...
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March 13, 2023
Industry Voices: Yannis Jemiai on Simulation-Guided Design and the Changing Landscape of Clinical Trial Strategy
Many industries have long since adopted the practice of modeling and simulating experimental scenarios. And despite..
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March 8, 2023
New Linked Database Expands Potential of RWE: A Unique Opportunity for Multiple Sclerosis Research
Real-world data has been increasingly used to answer questions related to the course, prognosis, and treatment of..
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March 7, 2023
Can RWE Help Restore Decades of Health Inequalities? Yes, and Here’s How
Grammati Sarri was recently interviewed by Inside Precision Medicine for “Improving Health Equity Starts with..
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March 3, 2023
Multiple Myeloma Research Benefits from Living Model SLR: A Case Study
The speed of scientific discovery has been outpacing the ability of researchers to accumulate and integrate constantly..
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February 14, 2023
FDA Guidance on the Design and Conduct of Externally Controlled Trials — What to Watch
The U.S. FDA has recently provided specific guidance[i] on the design and conduct of trials incorporating an external..
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January 31, 2023
Linked Data Studies: Improving the Way We Do Observational Research in Germany
Asthma affects more than 235 million people worldwide, and due to lacking effective implementation of clinical..
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November 3, 2022
Cytel at ISPOR Europe: Two Workshops
Cytel will be represented at over 60 presentations at ISPOR Europe 2022, with more issue panels and workshops than any..
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October 13, 2022
Cytel at ISPOR Europe: Top Presenter of Issue Panels and Workshops
ISPOR Europe, the leading global conference for health economics and outcomes research (HEOR) and real-world evidence..
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September 28, 2022
Statistical Leaders and the Future of Drug Development
The landscape of drug development has changed dramatically over the last few decades, and effective statistical leaders..
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September 27, 2022
Data Capture and Data Sharing During the COVID-19 Pandemic
On Louis Dron et al., “Data Capture and Sharing in the COVID-19 Pandemic: A Cause for Concern,” The Lancet 4 (10) (2022)
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September 15, 2022
U.S. Drug Pricing Reform: Potential Impact on Pharma HEOR Evidence Generation
On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022, which includes U.S. drug..
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August 25, 2022
Cytel Presents at ICPE 2022
The International Society for Pharmacoepidemiology is hosting its “ICPE 2022: Advancing Pharmacoepidemiology and..
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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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July 7, 2022
Using Quantitative Bias Analysis in Real World Data Strategy
The gold standard for assessing the efficacy for a medicine continues to be RCTs, however, for many reasons (disease..
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April 22, 2022
Cytel’s Single Arm Trials Panel Selected as a Part of ISPOR 2022
This past decade has undoubtedly witnessed an increase in the number of single arm trials submitted to HTA bodies...
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April 7, 2022
Bridging the gap between oncology clinical trials and real-world data: evidence on replicability of efficacy results using German claims data
Randomized control trials (RCTs) are the gold standard for estimating the efficacy of a treatment. They allow us to..
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April 1, 2022
A Spotlight on Our Scientific Community
At the end of every year, scientists from across Cytel’s business units are nominated for Cytel’s Spotlight Awards,..
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March 18, 2022
The Fundamentals of Real World Evidence in Oncology Drug Development
Real world evidence (RWE) provides a large and growing source of insights into drug uptake and safety. It is..
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January 19, 2022
What’s Ahead for Clinical Trial Design?
The past two years have been transformative for Cytel. Most notably, the global COVID-19 pandemic unleashed an..
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December 23, 2021
Year-End Roundup: Your Favorite Blog Posts of 2021
Cytel blogs bring you debate and discussion of the newest trends in statistics and quantitative strategy. In 2021, our..
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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 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 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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October 21, 2021
Measuring Non-Adherence and Non-Persistence
A number of methods currently exist to measure non-adherence and non-persistence of medical therapies, for improved..
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October 7, 2021
Non-adherence and Non-persistence
‘Drugs do not work in patients who do not take them,’ said former surgeon general C. Everett Koop. Unfortunately, the..
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September 30, 2021
Transportability Analysis - An interview with Miguel Hernán
A complex methodological issue which arises in the production of real-world evidence involves the degree to which..
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September 23, 2021
Transportability Analysis - An interview with Professor Miguel Hernán
A complex methodological issue which arises in the production of real-world evidence involves the degree to which..
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May 20, 2021
Quantitative Bias Analysis to Strengthen Comparative Effectiveness
As more payers and HTA agencies turn to real world data to compare the effectiveness of various treatment effects, two..
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May 13, 2021
An Interview with Radek Wasiak, Head of Real World and Advanced Analytics at Cytel
Cytel’s HEOR and RWE Expertise has grown quite significantly in the past year. Could you speak a little bit about the..
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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 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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March 26, 2021
Using External Evidence for Decision-Making for Medical Devices
Former Commissioner of the FDA, Dr. Scott Gottlieb, in several public presentations, would bemoan missed chances to..
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February 9, 2021
New Meta-Analysis in JAMA Uses Novel Quantitative Techniques to Demonstrate Baseline Characteristics Informing Response to Common Therapy for Kidney Cancer
Recent years have witnessed improving survival outcomes for those struggling with a range of common kidney cancers...
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February 1, 2021
February 2021: Updates from the CYTEL COVID-19 Trial Tracker
Cytel’s COVID-19 Trial Tracker continues to provide real time updates to the status of COVID-19 clinical trials..
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January 22, 2021
The Role of Real World Evidence after COVID19
COVID-19 has transformed the pharmaceutical industry in a manner that few could have predicted only a year ago. One of..
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January 11, 2021
COVID-19 Trial Tracker Updates (January 11)
In April 2020, Cytel launched an open-access global COVID-19 Clinical Trial Tracker to help facilitate greater..
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December 21, 2020
Year-End Roundup: Your Favorite Blog Posts of 2020
2020 has been an unusually difficult year as the global pandemic impacted all of our lives. This year, the Cytel blog..
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November 24, 2020
Cytel and Ingress Health at Virtual ISPOR Europe 2020
Virtual ISPOR 2020, held November 16 to 19, presented new opportunities for scientific interaction amongst HEOR..
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November 12, 2020
Join Cytel and Ingress Health at Virtual ISPOR Europe 2020
Cytel and Ingress Health (now a Cytel company) will be contributing to a range of events at Virtual ISPOR EUROPE 2020,..
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November 5, 2020
Role of RWA in Transforming Oncological Research
In oncology, many manufacturers go into niche indications, where there are very specific tumors, and then they opt for..
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November 3, 2020
Staffing Needs for RWE Delivery
When an expert statistician is paired with an experienced set of data managers, opportunities to capitalize on..
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October 22, 2020
An Interview with Bart Heeg (Part 2): New Trends in HEOR
In this two-part blog series, we interview Bart Heeg, Vice President HEOR and Founder at Ingress Health (A Cytel..
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October 20, 2020
Interview with Thomas Wilke: Health Economics/World Evidence Studies
In this interview with Thomas Wilke, Principal Scientist at Ingress-Health (a Cytel company), we talk to him about his..
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October 19, 2020
The Uniqueness of COVID-19 Data Challenges; The COVID-19 trial tracker
COVID-19 has created extreme uncertainties -- a dearth of historical information combined with the need for safety,..
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October 14, 2020
The Increasing Importance of Health Economics
A credible evidence base is needed to support and document the economic value of new technologies and therapeutic..
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October 13, 2020
Introducing Observational Studies – Three Trends for Statisticians
The combination of greater access to electronic health records, bigger electronic claims datasets, and the need for..
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October 7, 2020
RWE Needs for Natural History Studies
With the rise in digital technologies, there has been an explosion in the volume and type of data sources. We can..
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September 25, 2020
Use of External Controls in Clinical Development – Download Audiobook
Regulators in both the United States and Europe have responded positively to the use of synthetic control arms (SCA)s..
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September 16, 2020
New Audiobook on Synthetic Control Arms
Synthetic control arms (SCA) are virtual trial arms that use historical claims data and observational data to simulate..
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September 10, 2020
Does your Trial need a Synthetic Control Arm?
Single arm trials are emerging as an accepted way of assessing a new treatment intervention. They establish clinical..
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August 7, 2020
Creating a Synthetic Control from Your Natural History Study
Recently a biotech approached Cytel for support with a Phase 2 Study in oncology. Regulators had requested a natural..
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August 5, 2020
Design and Data Considerations from Cardiovascular Pilot Investigation
Cytel is conducting two pilot projects on head-to-head comparisons using real world data. These projects in oncology..
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July 23, 2020
Why Consider a Synthetic or External Control Arm?
Just as there are numerous adaptations that fall within the umbrella of adaptive designs, there are several different..
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July 21, 2020
Head to Head Comparisons Using Real World Data
Cytel is conducting a webinar series that focuses on target trial emulation and causal inference approaches using real..
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June 23, 2020
Design and Data Source Considerations from Pilot Investigations in CVD
Supposing two treatments, A and B, need to be compared that have not been compared through a clinical trial. In the..
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February 25, 2020
Bayesian Methods for Contending with Homogeneity and Heterogeneity in Real World Data
Over the past decade, a new trend began to emerge, changing the way that clinical trials are conducted. Whereas..
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February 25, 2020
Ensuring an Unbiased Comparator Arm
Regulators in both the United States and Europe have responded positively to the use of SCAs in clinical..
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February 20, 2020
Unlock the power of your clinical data with these five top tips
It is widely acknowledged among drug developers that one of their most important assets is the data generated during..
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January 22, 2020
What could you accomplish with a fresh approach to your clinical data strategy?
In the quest for clinical success, we all strive for evidence packages of the highest quality. If the clinical data is..
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December 18, 2019
Year-End Roundup: Your Favorite Blog Posts of 2019
With only two weeks left for this fabulous year to end, we would like to thank all our blog subscribers and new readers..
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December 10, 2019
Impact of AI on Clinical Development
In association with Statisticians in the Pharmaceutical Industry (PSI) , UCB and Cytel hosted a symposium on September..
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December 5, 2019
Biotechs and Medtechs, don’t forget your market access strategy (part 4 of 4): How to optimize your market access planning approach
Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel In..
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November 21, 2019
Biotechs and Medtechs, don’t forget your market access strategy (part 2 of 4): The critical role of market access planning in clinical development
Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel In my..
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October 10, 2019
The Challenges of Rare Diseases in Clinical Trials Symposium and Hands-on East Training
A disease is generally considered to be rare if it affects one patient per 200,000 people (1) and most rare diseases..
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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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August 23, 2019
Advancing Medicines Development with External Controls
In place of collecting data from patients recruited for a trial who have been assigned to the control or..
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August 1, 2019
Predictive Biomarker Signature Characterization
The term biomarker signature describes the behavior of a set of biomarkers that define a signature to maximize the..
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February 21, 2019
Podcast with Ursula Garczarek on The Effective Statistician
In 2018, Cytel ran a qualitative survey among biostatisticians and programmers on trends in data science and..
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September 10, 2018
Could data science be about to revolutionize the regulatory approval of new drugs?
The biopharmaceutical and healthcare industries now collect more data than ever before due to advances in the variety..
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June 14, 2018
What makes a good data manager?
In this blog, Paul Fardy, Executive Director of Data Management at Cytel shares his thoughts on how the data manager..
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February 28, 2018
Insight into the Coordination of Rare Diseases at Sanford registry
There is a consensus in the industry that data on rare diseases is limited, incomplete, and difficult to find or..
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April 28, 2017
Case Study: Redesigning a Pragmatic Trial in Oncology
In this blog we share a case study in which our statistical consulting team helped a client redesign an oncology..
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