Interview: Clinical Trial Optimization with R

Posted by Cytel

Nov 28, 2017 10:27:00 AM

 

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...

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Topics: Clinical Development Strategy, Cytel Consulting, Software Simulations


Career Perspectives: Interview with Makarand Deshmukh, Senior Clinical Data Analyst

Posted by Cytel

Nov 22, 2017 8:46:00 AM

Cytel offers a full range of clinical data management services and the team of experts is spread across the globe.

In this blog we talk to Makarand, who is based in India, to find out more about his career path, current role at Cytel and his interests outside of work. 

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Topics: Clinical Research Services, Statistical Analysis, careers, clinical data management, clinical research, Data Management, Statistical Programming


Highlights from PhUSE 2017

Posted by Cytel

Nov 17, 2017 5:00:00 AM

PhUSE 2017 took place in Scotland’s capital city Edinburgh, 8th - 11th October, and brought together a range of experts to tackle the most pressing issues facing statistical programmers today.  We found this year's event informative and well attended. In this blog we share some highlights from the sessions and posters the Cytel team attended.  We will share Cytel's own contributions in a...

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Topics: biostatistics, Interim Analyses, Statistical Programming, R programming, clinical trials, FDA, CDISC


Creating Efficiencies in the Vendor Qualification Process: A Proposal

Posted by Cytel

Nov 15, 2017 8:46:00 AM

Each year Halloran Consulting Group hosts‘CORE’ (Clinical Operations Retreat for Executives) as a forum for industry executives to discuss pressing challenges in a collaborative environment. This year, our Senior V.P. of Clinical Research Services, Irving Dark, discussed the topic of vendor qualification and posed the question to the group: are there better alternatives to the traditional...

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Topics: Clinical Research Services, Clinical Data, CRO, outsourcing


The Cytel Story: In the Co-Founders' Own Words

Posted by Cytel

Nov 9, 2017 11:43:00 AM

 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.

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Topics: biostatistics, Cytel Consulting, Clinical Development Strategy


Asking the Right Questions of Your Data: Experiences in Model Informed Drug Development

Posted by Cytel

Nov 6, 2017 5:28:43 AM

 At the Chief Medical Officer Summit earlier this year, Cytel's Director of Quantitative Pharmacology and Pharmacometrics Cecilia Fosser, and Senior Director, Business Development, Chuck Gelb presented on how model-informed drug development (MIDD) techniques can improve decision-making and Probability of Success ( PoS) of clinical trial programs.  In this blog, we share some highlights and the...

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Topics: model-informed-drug-development, pharmacometrics, biostatistics, Clinical Development Strategy


Innovative posters unveiled at ACoP8

Posted by Cytel

Nov 2, 2017 9:05:00 AM

 

Last month was the eighth American Conference on Pharmacometrics (ACoP8) in Florida, a key event on the calendar for Cytel’s Quantitative Pharmacology and Pharmacometrics subject matter experts.

Cytel was delighted to contribute to the event this year and present two posters. This was excellent opportunity to share our knowledge and innovative research, alongside networking with likeminded...

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Topics: Clinical Data, pharmacometrics, pharmacology, Clinical Research Services, model-informed-drug-development, clinical development, Phase 1


Webinar Replay: Dual Target Methods for Go/No-Go Decision Making

Posted by Cytel

Oct 31, 2017 10:42:00 AM

As part of Cytel's new Trial Innovations Webinar Series, Pat Mitchell, Statistical Science Director at AstraZeneca presented the October webinar "Formal Go/No-Go decisions are a key component of risk management in early clinical development."

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Topics: Adaptive Clinical Trials, Trial Design, phase 2, Bayesian, adaptive designs, clinical development, go-no-go, custom software


Design Concept for Confirmatory Basket Trial Interview with Bob Beckman: Part 2

Posted by Cytel

Oct 27, 2017 9:53:00 AM

In this blog, we share the second part of our interview with Bob Beckman, about a design concept for a confirmatory basket trial. Beckman is Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics at Lombardi Comprehensive Cancer Center and the Innovation Center of Biomedical Informatics, Georgetown University Medical Center. The first part of the interview, which...

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Topics: Clinical Data, adaptive designs, FDA, basket trials, Oncology


2017 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop

Posted by Cytel

Oct 24, 2017 6:01:00 AM

The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop is sponsored by the ASA Biopharmaceutical Section in cooperation with the FDA Statistical Association. Each year 800 statistical practitioners come together to absorb new information on statistical practices in all areas regulated by the FDA.

Cytel was honored to be involved in the workshop program, and our subject...

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Topics: Clinical Data, Clinical Research Services, Adaptive Clinical Trials, adaptive designs, Sample Size, adaptive sample size re-estimation, Bayesian, Regulation, FDA, Promising Zone


Webinar Replay: Phase 2 Trial Designs using Program-level Simulations

Posted by Cytel

Oct 18, 2017 11:03:00 AM

 

Cytel's new Trial Innovations Webinar Series provides a platform for the most promising new statistical approaches helping to bridge the gap from methodology to implementation. Ultimately, our goal is to enable our audience to improve their chances of success in clinical development.

The series got underway in August with a webinar on ‘Phase 2 Trial Designs using Program-level Simulations,...

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Topics: Adaptive Clinical Trials, Trial Design, phase 2, Program and Portfolio Optimization, Simulations


Highlights from the 2017 SCDM Program

Posted by Cytel

Oct 4, 2017 7:34:36 AM

The Society for Clinical Data Management (SCDM) conference landed in Orlando last week providing insights and key trends for clinical data managers from around the world.  In this blog we share an infographic of some of the agenda highlights along with a more detailed overview of our Alla Muchnik's contribution to the session Study Medication Compliance: Data Collection Challenges. 

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Topics: Interim Analyses, Clinical Data, Data Management, Clinical Research Services


Career Perspectives: Interview with Namrata Deshpande, Senior Team Lead

Posted by Cytel

Sep 29, 2017 3:01:00 PM

Namrata Deshpande, Senior Team Lead will be participating in a round table discussion at the Women in Statistics event in California, October 19-21.

This is the first blog in a new 'Career Perspectives' series and we talk to Namrata to find out more on her career path, achievements, current role at Cytel and her interests outside of work. 

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Topics: biostatistics, Clinical Research Services, Clinical Development Strategy, Statistical Innovations in Clinical Development, Statistical Analysis, Statistical Programming, careers, East, R programming


Case Study: Accurate Event Prediction in a Cardiovascular Outcomes Research Trial

Posted by Cytel

Sep 20, 2017 8:50:19 AM

 

In this blog we share a case study of work our strategic consulting team conducted supporting accurate event prediction for a cardiovascular outcomes research trial using the Major Adverse Cardiac Events ( MACE) composite endpoint. 

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Topics: biostatistics, Cardiovascular, time to event trials


How to handle conservativeness of Exact p-value?

Posted by Ashwini Joshi

Sep 18, 2017 7:38:45 AM

 

By Ashwini Joshi

For small sample data or rare events data, exact non-parametric tests perform better than asymptotic tests. But they come with the disadvantage of conservativeness. Many corrections have been suggested to reduce this conservativeness but none of them solve the problems entirely.  StatXact provides various methods of computing exact p-values. Depending upon the problem at...

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Topics: biostatistics, p value, StatXact, exact statistics, Small Sample Sparse Data, Exact Tests


How can Novel Statistical Methods Tackle Antibiotic Resistance? Interview with Scott Evans

Posted by Cytel

Sep 13, 2017 9:00:00 AM

Antibiotic resistance is one of the greatest challenges facing human health today. We are excited to welcome Dr. Scott Evans of the Harvard T.H Chan School of Public Health (HSPH) to the blog to discuss how the novel statistical methods he is developing could help tackle this global crisis.

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Topics: biostatistics, Clinical Research Services, Clinical Development Strategy, Statistical Innovations in Clinical Development, Antibiotic resistance


Design Concept for Basket Trials: Interview with Bob Beckman

Posted by Cytel

Sep 11, 2017 11:25:00 AM

At the East User Group meeting (EUGM) on 25th and 26th October, we will welcome a number of renowned industry speakers to discuss some of the most promising approaches in innovative trial design. Over the next few weeks, we will profile a number of the speakers and their talks. In this blog, we talk with Bob Beckman M.D in advance of his presentation ‘Design Concept for a Confirmatory Basket...

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Topics: biostatistics, Clinical Research Services, Clinical Development Strategy, Statistical Innovations in Clinical Development, East, Oncology, basket trials


Removing 'Noise' from Biomedical Signals

Posted by Munshi Imran Hossain

Sep 7, 2017 7:00:24 AM

By Munshi Imran Hossain, Software Affiliate at Cytel

Biomedical signals are electrical signals collected from the body. Some of the most common ones are the electrocardiogram (ECG) and the electroencephalogram (EEG). These signals are of great value because they can be used for diagnostic purposes. Importantly, most of them can be collected using non-invasive methods. These attributes,...

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Topics: data science, signal processing, biomedical signals, Fourier


Highlights from the 2017 JSM Program

Posted by Cytel

Aug 15, 2017 7:16:00 AM

Last month, Cytel statisticians headed to Baltimore for the Joint Statistical Meetings and shared some of their latest research and insights.  In this blog we will summarize our highlights -both from Cytel contributions and the sessions Cytel delegates attended. We also provide access to the valuable slide decks from the Cytel authored presentations. 

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Topics: biostatistics, adaptive designs, Adaptive Clinical Trials, Interim Analyses, JSM


4 Questions to Explore in Model-Informed Drug Development (Infographic)

Posted by Cytel

Aug 10, 2017 1:18:46 PM

Model-informed drug development has been defined by Richard Lalonde ( Lalonde, 2007) (1) as “Development and application of pharmaco-statistical models of drug efficacy and safety from preclinical and clinical data to improve drug development knowledge management and decision-making”. It has  been identified by the FDA as an important way to help reduce attrition and uncertainty in drug...

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Topics: pharmacology, pharmacometrics, Simulations, model-informed-drug-development


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