Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.
April 26, 2024
Written by Marie Diamond and Maria Rizzo Systematic literature reviews (SLR) are essential to informing healthcare...
Read article
April 17, 2024
Early Planning Strategies for External Control Arms in HTA and Regulatory Submissions
Written by Grace Hsu, Evie Merinopoulou, and Jason Simeone To establish treatment efficacy and safety, regulatory and...
Read article
April 12, 2024
The New EU HTA Landscape: Insights on Indirect Evidence
How should health technology developers prepare for future market access activities in Europe? Numerous discussions...
Read article
April 10, 2024
Orphan Drug Designation for Rare Diseases
Orphan drug designation is a regulatory status granted to pharmaceuticals developed for the treatment of rare diseases....
Read article
April 3, 2024
Developing a New Drug Candidate: From Nonclinical to First-in-Human
Thank you to Charlotta Gauffin, Chief Scientific Officer at Dicot, for joining us for our recent webinar, “The Road to...
Read article
March 20, 2024
Key Elements and Implications of the Draft EU JCA Implementing Act
Written by Lydia Vinals, PhD, and Grammati Sarri, PhD The draft Implementing Act of the EU Health Technology Assessment...
Read article
February 14, 2024
Erika Spens on Developing Your Regulatory Strategy
During drug development, a comprehensive regulatory strategy is key for saving time and money. There are many common...
Read article
January 22, 2024
How to Save Time and Limit Costs toward First-in-Human Clinical Trials
Regulatory guidelines outline all crucial studies and documentation that should be in place before a drug product can...
Read article
December 29, 2023
The Top Most-Read Posts of 2023
What a year! Perspectives has explored a myriad of topics this year within clinical development — from adaptive trial...
Read article
December 27, 2023
Top Data Submission and Data Integration Posts of 2023
Perspectives covers a wide range of topics related to data submission and data integration, from ISS and ISE best...
Read article
December 22, 2023
Top Therapeutics Development Topics of 2023
Perspectives covers a wide range of topics within therapeutics development from advice on regulatory submission to...
Read article
December 20, 2023
Top Real-World Evidence and Real-World Data Topics of 2023
Perspectives covers a wide range of topics related to real-world evidence and real-world data, from overcoming health...
Read article
November 29, 2023
Don’t Forget the Development of Your Placebo: Overcoming Common Obstacles
A clinical trial is usually performed using some kind of comparator. This could be another drug on the market, or a...
Read article
November 20, 2023
Guidelines Are Not Instruction Manuals: Customize Your Way to First-in-Human Clinical Trials
Interpreting all guidelines before your first-in-human clinical trials can be overwhelming. While guidelines are...
Read article
November 13, 2023
First-in-Human Drug Substance and Formulation: The Challenge of Achieving Flexibility and Quality
For nonclinical studies that precede Phase I, a drug formulation in high doses and concentrations is required. While...
Read article
November 8, 2023
Aligning Clinical Trial Design with Investment Priorities
Written by Natalia Muehlemann, Vice President, Clinical Development, and Ari Brettman, Senior Managing Director,...
Read article
November 6, 2023
Ulrika Andersson on First-in-Human Clinical Trial Development
The first-in-human trial, which aims to show the safety and tolerability of a new drug, is a major milestone for any...
Read article
October 18, 2023
Preparing Your Integrated Summaries of Safety and Effectiveness: Best Practices
Written by Angelo Tinazzi and Florence Le Maulf Integrated Summaries of Safety (ISS) and Integrated Summaries of...
Read article
October 6, 2023
Writing a Successful Study Protocol for Real-World Evidence Studies
Real-world evidence studies are becoming increasingly popular in pharmaceutical development. But to ensure such studies...
Read article
October 4, 2023
How to Ensure Your Adaptive Trial Is Appropriate for Regulatory Submission
Adaptive clinical trial designs have become increasingly popular among developers and investors due to the many...
Read article
September 11, 2023
How to Ask the Right Questions at an Authority Meeting
As a drug developer, you have to live with the answers and comments you get from regulatory authorities. Therefore,...
Read article
August 1, 2023
Dynamic Bayesian Borrowing to Bolster Limited Sample Sizes in Rare Indications
Evaluating the efficacy and safety of novel therapies in rare indications can be challenging due to the difficulty of...
Read article
July 28, 2023
Embracing AI and ML in Medical Devices: FDA’s Total Product Lifecycle-Based Regulatory Framework
Written by Fei Tang, RWE Senior Research Consultant, and Paul Arora, Assistant Professor (Status), Dalla Lana School of...
Read article
July 14, 2023
Real-Life Data-Sharing and EU Joint Clinical Assessments: Is Closing this Chasm a Mission Impossible?
Written by Grammati Sarri, David Smalbrugge, Andreas Freitag, and Evie Merinopoulou The vision of a single, centralized...
Read article
June 20, 2023
New FDA Guidelines on Pediatric Studies and Potential Effects on Opportunities for Market Exclusivity
Legislation on pediatric studies has existed for more than 20 years in the US, yet additional guidance from the FDA has...
Read article
June 5, 2023
Maria Lundberg on a Holistic Approach to Therapeutics Development
Cytel recently announced the launch of its Therapeutics Development Team, bringing together quantitative,...
Read article