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 separate article.

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


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


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


Case Study: Seamless Independent Data Monitoring Committee Support

Posted by Cytel

Jul 19, 2017 9:00:13 AM

With adaptive and innovative trial designs on the rise, operational implementation of interim analyses, including management of Independent Data Monitoring Committees is increasingly important.  In this blog, we will share a case study of how Cytel provided a client with seamless Independent Data Monitoring Committee support encompassing committee selection and management, independent statistical services, and ACES software. 

 

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Topics: Clinical Research Services, Statistical Programming, Interim Analyses, ACES, biostatistics, DMC


Measuring Intergroup Agreement and Disagreement

Posted by Cytel

Jun 8, 2017 9:50:07 AM

 

Cytel's Madhusmita Panda presented at this year’s PSI Conference in the Innovative Methodology session on the topic of ‘Measuring Intergroup Agreement and Disagreement’.

In this blog, we share the context, abstract and slides from Panda’s presentation. 

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Topics: Trial Design, Interim Analyses, Statistical Analysis, Clinical Development Strategy, biostatistics


Jim Bolognese named 2017 American Statistical Association Fellow

Posted by Cytel

May 22, 2017 9:00:00 AM

James (Jim) Bolognese, Senior Director, Strategic Consulting, Clinical Services at Cytel Inc. was named a 2017 fellow of the American Statistical Association (ASA). Jim will be officially honored by the ASA at the Joint Statistical Meetings in Baltimore, Maryland this summer.

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Topics: Cytel Strategic Consulting, Interim Analyses, Statistical Analysis, Clinical Development Strategy, Adaptive Clinical Trials, biostatistics, adaptive designs


The Insider View: PSI 2017 Conference Preview

Posted by Cytel

May 10, 2017 5:48:04 AM

PSI is a global member organization dedicated to leading and promoting best practice and industry initiatives for statisticians in the biopharmaceutical industry.  2017 marks a significant milestone for the organization's PSI conference as it hits its 40th year of promoting statistical insight. This is reflected in its status as the key event on the calendar for statisticians in the biopharmaceutical industry in Europe and beyond.

With less than a week to go until the 2017 event gets underway in London,14th - 17th May 2017, we chatted with Lucy Rowell, this year’s Conference Chair to get the scoop on the secrets of the conference’s success, this year’s hot topics, and her insider insights into the keynotes and workshops.  

 

 

 

 

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


In the Midst of this: The Data Management Perspective on the Interim Analysis

Posted by Cytel

May 4, 2017 9:07:00 AM

 As a recognized expert in adaptive trials, Cytel has extensive experience designing and managing trials with interim analyses.  To ensure success in what are often complex studies, data management as well as statistical expertise is required.  Cytel data managers are well versed in the various nuances and demands of managing the successful delivery of an interim analysis from a data collection point of view. 

Success from the data management standpoint depends on three core elements- effective timeline management, thoughtful database design, and a proactive approach to data cleaning. In this blog, Patti Arsenault, our Global Head of Data Management shares her thoughts.

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Topics: Data Management, Interim Analyses, EDC


Critical Operational Considerations for Interim Analyses

Posted by Cytel

Apr 25, 2017 6:24:00 AM

At a recent conference Adam Hamm, Director Biostatistics at Cytel, presented his thoughts on Best Practices and Operational Considerations for Adaptive Designs and Interim Analyses. In this blog, we share some highlights from his presentation, drawing out some of the key operational priorities from the biostatistician's point of view. 

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


Inside an Oncology Statistician's Toolkit

Posted by Adam Hamm

Feb 9, 2017 7:34:58 AM

 

 

 In this blog, Adam Hamm, PhD, Director Biostatistics at Cytel shares some of the most important knowledge he uses in  his day to day work as a biostatistician working extensively in oncology research. Adam has broad experience with statistical analysis and methodology over all phases (I-IV) of development, in particular working in the oncology arena. 

 As a Director of Biostatistics at Cytel, I work on design, statistical analysis and reporting projects for a range of biotechnology and pharmaceutical sponsors. During my career, I’ve developed a particular focus on oncology trials, so in this blog I’ll share some insights into the  knowledge which I have found particularly vital  as a biostatistician working in this area. This knowledge spans specific statistical methodologies and understanding of the clinical issues across the phases of clinical development. The summary is not exhaustive, but provides a glimpse into the broad exposure which is needed for a biostatistician to develop a fully rounded understanding in the area. To learn more, read on...

 

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Topics: Oncology, Dose-Escalation, Interim Analyses, Phase 1, Dose-Finding, Early Phase Trials, Phase 3, phase 2, biostatistics, adaptive trials


Infographic: 10 steps to consider before choosing an adaptive design

Posted by Cytel

Nov 21, 2016 11:42:00 AM

While adaptive designs can deliver significant benefits to clinical development-  including ethical benefits for patients, reduced costs, and improved likelihood of trial success- they are not suitable for every clinical trial.  In making the assessment of whether or not to choose an adaptive design, trial planners need to weigh the strategic benefits against the practical implications. 

We have previously discussed on the blog, the 10 steps proposed by Jim Bolognese and Ranganath Nayak to assist sponsors in making this decision. In this blog, we are delighted to share a simple infographic outlining the process. 

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Topics: Clinical Research Services, Interim Analyses, Clinical Development Strategy, trial planning, adaptive designs, adaptive trials, DMC, infographic


Determining the future course of your trial

Posted by Cytel

Jun 16, 2016 10:23:00 AM

 Predicting the course of a clinical trial is something which people will always want to do-whether for statistical reasons, planning reasons or business reasons. In this blog we look at examples of where prediction goes off course, and how we can resolve these issues.  We also share valuable video and slidedeck resources from our VP Consulting and Software, Yannis Jemiai.

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Topics: East, East PREDICT, Interim Analyses, Cytel Videos, Cytel Events, clinical development, EAST 6.4, adaptive designs, adaptive trials, DMC


Managing DMC analysis- an innovative programming solution

Posted by Cytel

Jun 14, 2016 8:00:00 AM

At Cytel, we are very often asked to get involved in DMCs ( Data Monitoring Committees)  in a variety of capacities. Our statistical experts are recognized for their work in many of the areas related to DMCs including-group sequential and adaptive designs, multiplicity, missing data, and decision sciences.  One key operational management issue when producing analysis for DMCs  is that rules must be defined so that trial unblinding is not compromised and bias remains controlled.  In this blog, we will explore an innovative approach developed by members of our statistical programming team to improve the efficiency of this process, while maintaining the highest levels of data security. 

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Topics: Clinical Research Services, Statistical Programming, Interim Analyses, Blind and Unblind Trials, Clinical Data, ACES, biostatistics, DMC


How to Plan Interim Looks in Adaptive Clinical Trials: 3 Strategies

Posted by Esha Senchaudhuri

Mar 19, 2015 5:26:00 PM

A well-timed interim analysis can generally supply added benefits to the operational and administrative aspects of a clinical trial. Particularly when clean data and safety adjudications provide information that is instrumental for stopping a trial early or informing sensitive interim decisions, the timing of an interim look may play a crucial role in leveraging all of the flexibility that a complex, adaptive design has to offer. 

 
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Topics: Interim Analyses, Cardiovascular, Cytel Events, Statistical Innovations in Clinical Development


How to Shorten a Cardiovascular Outcome Trial By Two Years

Posted by Esha Senchaudhuri

Feb 10, 2015 5:28:00 PM

Cardiovascular outcome trials (CVOTs) have earned the reputation of being the untamable behemoths of the clinical world. Needless to say these trials are long and require extremely large sample-sizes. The Contrave LIGHT study required 8900 patients. The SAVOR TIMI trial enrolled 16,492 patients. Even the EXAMINE trial, which benefited from a promising zone design, required 650 patients. 

However, since the explosive controversy over the FDA’s conditional approval of anti-obesity drug Contrave four years ago, there is much we have learned about how to make these trials shorter while also diminishing the financial risks of investing in them. For example, one of our clients managed to shorten the expected study length of an a CVOT by two years using a four point MACE Assessment (see below). 

In this post, we explore some of the lessons we have learned when designing these large-scale clinical trials.  

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Topics: Cyrus Mehta, Promising Zone, Cytel Strategic Consulting, Interim Analyses, Program and Portfolio Optimization, Cardiovascular, Clinical Development Strategy, Adaptive Clinical Trials


Drug Supply Planning for Dose-Ranging Adaptive Trials

Posted by Esha Senchaudhuri

Dec 9, 2014 12:17:28 PM

When planning a conventional trial, one can anticipate the drug supply necessary for the trial by determining how the number of patients reflected in the sample size will distribute across the trial sites. Implementing an adaptive trial, by contrast, raises many challenges for predicting the necessary drug supply. It can require planning for different sample sizes depending on the outcome of an interim look; or preparing different dosages if certain arms of a multi-arm trial are to drop after the interim look. In the case of a biomarker-driven adaptive design, determining adequate drug supply may require the ability to predict which doses are necessary for different subpopulations at particular trial sites.

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Topics: Nitin Patel, Access to Slides PDF, Bayesian Methods, Interim Analyses, optimization, Dose-Finding, Adaptive Clinical Trials


5 Scenarios When ‘Keep it Simple’ May Be Bad Advice for Clinical Trial Designers

Posted by Esha Senchaudhuri

Sep 18, 2014 10:44:00 AM

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 Senior Director at Cytel Consulting, there is reason to doubt such conventional wisdom. After all, flexibility is hardly a virtue of a traditional trial design. Simple designs may seem to make it easier to monitor data and report results. However, a flexible design can better address remaining uncertainties in product development. These uncertainties are related to treatment effect, dose selection, or a sub-population that would experience the best benefit/risk from the treatment.

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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


FDA-Industry Session on Cardiovascular Outcome Trials: Mehta on EXAMINE Trial’s Promising Zone Design

Posted by Esha Senchaudhuri

Sep 9, 2014 10:41:00 AM

 

The FDA requires sponsors of new antidiabetic drugs to conduct cardiovascular outcome trials (CVOTs). CVOTs demonstrate that new therapies do not place unacceptable cardiovascular risk on patients suffering from Type 2 diabetes. The average CVOT requires about 5000 patients and takes an average of 5 years to complete. However, a recent white paper by the Cardiac Safety Research Consortium outlines a variety of methods to decrease sample size and study duration, by employing group sequential and adaptive CVOT designs. 

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Topics: Cyrus Mehta, Promising Zone, Trial Design, FDA, Interim Analyses, Cardiovascular, Adaptive Clinical Trials


Overcoming Prowell's Pitfalls: Cytel Weighs in on Strategies for Oncology Development

Posted by Esha Senchaudhuri

Jun 10, 2014 7:01:00 AM

 East: Learn More

The FDA’s Tatiana Prowell (Breast Cancer Scientific Lead in the Office of Hematology  & Oncology Products) recently gave an interview to the Nature Review Drug Discovery, in which she discusses the top three pitfalls faced by drug developers in oncology. Issues which Prowell cite include: selection of appropriate dosage, trial designs without sufficient thought given to interim data, and untimely decisions on the use of biomarkers.

According to the article, “some 90% of drugs that enter phase 1 eventually fail.” The prevalence of these pitfalls is noteworthy for oncology drug development, not least becaues of how easy they are to avoid.When coupled with innovative trial design can achieve significant benefits in efficacy and cost-effectiveness. For example, model-based dose-escalation methods can be used to improve the model dose toxicity profile of the drug in question. Cytel Statistician Charles Liu shows how simple it is to use Cytel’s software to select the optimal dose to carry forward.

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Topics: Oncology, East, Regulation, FDA, East PREDICT, Predictive Enrichment, Interim Analyses, Prediction


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