Perspectives on Enquiry & Evidence

Cytel's blog featuring the latest industry insights.

Featured post

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, it’s essential that you choose your questions carefully and avoid questions you don’t need answers to. Here we take a closer look at how to approach these meetings.

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Perspectives on Enquiry and Evidence

August 28, 2023

How to Create and Optimize a Clinical Development Plan

A clinical development plan — a comprehensive strategy for developing an investigational product through regulatory...

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October 28, 2022

Measuring Robustness of Clinical Trial Designs with Pressure Tests

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

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July 29, 2022

Advancing Clinical Trials with Digital Tools: Simulation-Guided Design

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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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April 27, 2022

Reinventing Clinical Trial Design: Digital Development

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

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March 23, 2022

How to Use Historical Data to Mitigate Clinical Trial Risk

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

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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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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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October 14, 2021

Weighting and Prioritization for Trial Selection: New Webinar

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

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June 30, 2021

Mathematical Methods for Clinical Trial Financial Strategy

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

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June 23, 2021

Eliminating Underperforming Clinical Trial Designs

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

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June 18, 2021

Use of Scoring Functions for Clinical Trial Optimization

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

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May 14, 2021

Starting the Conversation Early: Incorporating Business Considerations in Optimal Selection of Trial Design

When developing clinical strategy, applying familiar business principles to the specific requirements of clinical...

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April 28, 2021

Trial Selection: From Art to Science

Recently, Cytel co-founder Professor Cyrus Mehta noted that, “Clinical trial design selection is too much like an art,...

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April 20, 2021

New Dimensions of Clinical Trial Optimization

For much of the past three decades, even as methodologies for clinical trial design have advanced and refined, the idea...

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March 19, 2021

5 Steps to Regulatory Success with Wearables Designs

The use of wearable and digital technology requires considerations for both drugs and devices regulations, and...

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March 18, 2021

Computing & Statistics: Are You Ready for the Industry Transformation?

Over the past ten years High-Performance Computing (HPC) has transformed medical research through advances in genomics,...

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March 12, 2021

Wearables: Translating raw data to actionable information

With wearables likely to become a regular part of clinical trial design, statisticians could benefit by familiarizing...

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March 11, 2021

Data and analysis in Modern Oncology Clinical Development

In the recent years, Oncology trials are seeing a technological shift that is expected to make them faster and more...

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February 25, 2021

Use of Wearables in Confirmatory Clinical Trials

The convergence of several distinct trends has made wearables an increasingly attractive option for use in confirmatory...

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February 19, 2021

Selecting Your Next Clinical Trial Design Using Quantitative Methods

C-Suite and R&D Decision-Makers are always striving to make evidence-driven decisions. Yet the rules by which evidence...

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February 11, 2021

The biostats and clinical overview of a growing clinical strategy

The past two years have witnessed a heightened interest in the use of wearables in clinical development. The unexpected...

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