In this blog we turn to some reading matter, and interview Gautier Paux and Alex Dmitrienko about the recent book 'Clinical Trial Optimization with R'.  The book explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. To learn more, read on for Paux and Dmitrienko's...

Topics: Clinical Development Strategy, Cytel Consulting, Software Simulations

 In this blog we are excited to unveil a new project which we have been hard at work on over the last few months. 

2017 marks a very special milestone for Cytel – our 30th anniversary.  Cyrus Mehta and Nitin Patel founded Cytel in 1987 with an initial objective to solve a specific problem in computational statistics.

Topics: biostatistics, Cytel Consulting, Clinical Development Strategy

Single ascending dose (SAD) and multiple ascending dose (MAD) studies are typically the first in human studies.  They seek to gain information on safety and tolerability, general pharmacokinetic (PK) and pharmacodynamic ( PD)  characteristics, and of course identify the maximum tolerated dose (MTD).

Conventionally, SAD  and MAD studies were conducted separately, but increasingly are combined...

Topics: biostatistics, adaptive trials, adaptive designs, Cytel Strategic Consulting, Cytel Consulting, Statistical Programming, Compass, Dose-Finding, Phase 1, Phase I

As a group, Cytel had over 40 successful regulatory interactions last year, many of which supported approvals for innovative trial design approaches.  In this blog we look at some of the key success factors for regulatory interactions regarding adaptive designs.

Topics: biostatistics, adaptive trials, adaptive designs, Regulation, Cytel Strategic Consulting, Cytel Consulting

 

 Francois Beckers, Global Head of Biostatistics & Epidemiology at Merck KGaA joined us at the East User Group Meeting in March and presented case studies of Merck KGaA’s experiences with Blinded Sample Size Re-estimation in early phase studies, more specifically in the context of biosimilar studies.

 

Topics: sample size re-estimation, Cytel Consulting, Cytel Videos, Phase 1, Early Phase Trials

On March 16th and 17th the 5th East User Group Meeting took place in London.  This very successful 2 days saw a variety of talks on aspects of clinical trial design innovation.  Over the next couple of weeks, we will be reviewing some of the key topics which were addressed during the meeting.

In this post, we'll take a look at Paul Frewer of Astrazeneca's presentation on Decision Making in...

Topics: Bayesian Methods, Cytel Consulting, Cytel Videos, Phase 1, Early Phase Trials, phase 2

 

Topics: Bayesian Methods, Cytel Consulting, Case Study, Adaptive Clinical Trials

Topics: Cytel Consulting, Early Phase Trials, Clinical Development Strategy, Proof-of-Concept, Case Study, Biomarkers, Simulations

Topics: Cytel Consulting, Early Phase Trials, Clinical Development Strategy, Adaptive Clinical Trials, psychiatry and neuroscience

Richard Branson once wrote: “I have always valued capability over expertise. While you may need to hire specialists for some positions, take a close look at people who have thrived in different industries and jobs – they are usually more versatile, have transferable skills, and can potentially tackle problems creatively.”

He goes on to write: “Obviously a healthy mix of experience and novel...

Topics: Nitin Patel, Cytel Consulting, Entrepreneurship, Clinical Development Strategy, Richard Branson

We are often asked how statistical consultants can add value to the clinical development process. What do they contribute to a winning strategy, and how do they optimize business decisions? 

Statistical consultants often have decades of experience in multiple aspects of clinical development, including trial design, portfolio optimization, and regulation. Having a broad and yet nuanced feel...

Topics: Cytel Strategic Consulting, Cytel Consulting, Data Management

Guest blogger Laurie Halloran is the President and CEO of Halloran Consulting Group, a management consulting firm for the life-sciences industry. Here she offers her take on the importance of accountability, obligation and 'ownership' in consulting for pharmaceuticals and medical device companies.

Topics: Clinical Research Services, Cytel Consulting, outsourcing

 

 

A few weeks ago, we posted a synopsis of an event held at ISCB Vienna in which statisticians from Cytel, SAS and Stata spoke about processes for developing software for statisticians. The button below will guide you to a copy of the presentation by...

Topics: East 6.3, Cytel Consulting, Regulation, Statistical Programming, Entrepreneurship

When designing clinical trials, many trial designers are advised to keep the trial simple. Prima facie, the keep it simple principle seems like sound advice. There are various logistical uncertainties that arise when implementing a clinical trial, and the more simple a trial – so conventional wisdom says – the easier it is to respond to these uncertainties.

According to Zoran Antonijevic, a...

Topics: Oncology, Promising Zone, sample size re-estimation, Enrichment, Cytel Consulting, Efficacy, Interim Analyses, forecasting, optimization, Program and Portfolio Optimization, R&D, Adaptive Clinical Trials

Topics: Cytel Consulting, Adaptive Clinical Trials

Photos leaked from JSM 2014 appear to show the Reverend Bayes partying with his entourage at the Cytel Cocktail Hour, held at Boston’s Seaport Hotel on August 4, 2014. Bayes is, of course, one of the stars of Cytel’s East 6.3, a modular software package driving drug development through high quality trial design and simulations. Bayes's contributions to the East ESCALATE and East PREDICT...

Topics: East 6.3, Dose-Escalation, Bayesian Methods, Cytel Consulting, East PREDICT, East ESCALATE

 

PROCYSBI, the first drug to receive FDA approval after following an adaptive population re-assessment design, was one of Cytel's most exciting success stories. Could your drug be next?

 

It has become popular to rave about the many regulatory, statistical and financial benefits of adaptive designs when compared to the inflexibility of conventional trials. However, the reality is that not...

Topics: Cytel Consulting

Pantelis Vlachos, PhD, is a Director at Cytel Consulting. He works with a team of experts who regularly assist clinical study teams with the design and implementation of Bayesian methods. In this blog post, Pantelis describes key benefits of Bayesian analyses for clinical trials.

Topics: Bayesian Methods, Cytel Consulting, Trial Monitoring

Cytel Consulting's Zoran Antonijevic

The key focus of precision medicine is identification of patients who would most benefit from a treatment. Proper enrichment of patient population greatly improves the probability of regulatory approval as well as product differentiation through improved efficacy and safety. Greater product differentiation leads to greater market access, as reimbursement is...

Topics: Enrichment, Cytel Consulting, Adaptive Clinical Trials

Here at Cytel we firmly believe that if you don’t get the design of a clinical program right, then nothing else matters. A study recently published by the Journal of the American Medical Association, once again confirms the vital importance of proper trial design for the timely approval of a new drug. The article reports that nearly half of all submitted NME applications fail upon first...

Topics: Cytel Consulting, Trial Design, Efficacy, Regulation, Safety