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 qualification audit process? In this blog, we present Irving’s proposal for an innovative approach that could improve efficiency and allow sponsors to invest more time evaluating the operational and cultural aspects that have greater potential to ensure the success of a partnership

Read More

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


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.

Read More

Topics: Cytel Consulting, Clinical Development Strategy, biostatistics


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 informative10-minute video replay of their talk which includes a modeling and simulation case study. 

Read More

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


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 industry professionals.  

Read More

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


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."

Read More

Topics: Trial Design, Adaptive Clinical Trials, phase 2, go-no-go, clinical development, adaptive designs, Bayesian, 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 focuses on the context of the design is available to read here.  Otherwise, read on to learn more details about this innovative design which has the potential to drastically increase drug development efficiency. Beckman presented on this topic at Cytel's East User Group Meeting in October.

Read More

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


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 matter experts added value to the conference by sharing their academic and regulatory experiences.

Don’t worry if you missed the event!

In this blog, we share the full slide set slide from Cytel contributions at the ASA Biopharmaceutical Section Regulatory Industry Statistics Workshop.

Read More

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


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, and Possible Adaptive Approaches’.

Read More

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

Read More

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


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. 

Read More

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


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. 

Read More

Topics: Cardiovascular, biostatistics, 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 hand, the user can decide which one to use.
Let’s consider a hypothetical example of stratified count data. The example shows two sample data with two strata. Events in Treatment1 are rare as compared to the ones in Treatment0. But the event rates are comparable.

Read More

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


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.

Read More

Topics: Clinical Research Services, Clinical Development Strategy, Statistical Innovations in Clinical Development, biostatistics, 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 Trial'. This, the first part of a two-part interview will reveal Bob’s insights into basket trials and their potential. The second part of the blog will delve more deeply into the design concept itself and will be published after the East User Group Meeting. To learn more, read on.

Read More

Topics: Oncology, East, Clinical Research Services, Clinical Development Strategy, Statistical Innovations in Clinical Development, biostatistics, 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, together with the tremendous recent advances in electronic and digital processing technology, have made biomedical signal data an important source of data used in medical diagnostics.

Read More

Topics: signal processing, data science, 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. 

Read More

Topics: Interim Analyses, Adaptive Clinical Trials, biostatistics, adaptive designs, 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 development.
In a recent FDA Voice article,(2) FDA Commissioner Scott Gottlieb noted the critical role which modeling and simulation can play in making clinical development more efficient.

He commented that:
“FDA’s Center for Drug Evaluation and Research (CDER) is currently using modeling and simulation to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, optimize dosing, predict product safety, and evaluate potential adverse event mechanisms. We’ll be putting out additional, updated guidance on how aspects of these in silico tools can be advanced and incorporated into different aspects of drug development.”

In this blog, we share a new Cytel infographic highlighting 4 key questions a sponsor can explore to apply these approaches within their development programs.

Read More

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


Case Study: Cross-study Efficiencies in Biometrics Outsourcing

Posted by Cytel

Aug 2, 2017 7:07:00 AM

As a  biometrics -focused CRO, Cytel regularly works across a program of studies, providing data consistency, and helping to minimize the oversight burden for the sponsor. In this case study, we describe our work with a client on two Phase 1 studies, and how we were able to carry a number of important efficiencies from the first study to the second.  

Read More

Topics: Clinical Research Services, Statistical Programming, Phase 1, outsourcing, Clinical Data, biostatistics, clinical data management, medical writing


Are Adaptive Designs the Answer to Oncology Development Success?

Posted by Cytel

Jul 26, 2017 10:05:39 AM

Sadly, clinical development of anti-cancer therapeutics faces particularly high rates of failure, even in the context of low success in drug development as a whole. Operating costs for oncology trials are also higher than those observed across the spectrum of clinical development.  In a recent article produced for the Pink Sheet ( a leading provider of  insights and analysis for biopharma leaders)  Cytel's Yannis Jemiai explored the key challenges facing oncology development today, and discussed how adaptive designs can help to improve researchers' probability of success. The article tackles the application of adaptive designs in both exploratory and confirmatory development and the potential benefits to stakeholders, including patients. 

Read More

Topics: Oncology, Phase 1, Clinical Development Strategy, Phase 3, Adaptive Clinical Trials, biostatistics


Don’t miss these 5 session picks at JSM

Posted by Cytel

Jul 25, 2017 7:37:09 AM

The Joint Statistical Meetings (JSM) is the largest and arguably most highly respected gathering of statisticians in the world.  It will bring together over 6000 statisticians and runs from Saturday, July 29, to Thursday, August 3, 2017. With over 600 sessions,  it can be a challenge to identify the most crucial ones to attend. To help out, we've asked some of the Cytel team for their top picks this year. 

Read More

Topics: Oncology, Clinical Research Services, Statistical Programming, Statistical Analysis, Clinical Development Strategy, Adaptive Clinical Trials, Statistical Innovations in Clinical Development, biostatistics


The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.  Sign up for updates direct to your inbox. You can unsubscribe at any time.

 

Posts by Topic

see all

Recent Posts