Interview: How can a Bayesian framework support benefit risk assessment?

Posted by Cytel

May 30, 2017 8:06:00 AM


A recent paper The case for Bayesian methods in benefit-risk assessment: Overview and future directions (1)  co-authored by Cytel Senior Vice President Consulting  Yannis Jemiai and published in Therapeutic Innovation and Regulatory Science, tackles the critical issue of benefit risk assessment, and the part Bayesian approaches can play in resolving their challenges.

There is certainly an industry- wide need for more transparent, targeted and robust benefit risk assessments. In this blog we talk with Yannis about the article and why the Bayesian framework is particularly well suited to these efforts. 

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Topics: Bayesian Methods, Statistical Analysis, biostatistics, Bayesian, benefit risk assessment


Cytel statistical programmer gains recognition at PharmaSUG 2017

Posted by Cytel

May 26, 2017 12:25:00 PM

PharmaSUG 2017 proved to be an inspirational and informative event. With over 200 paper presentations, posters, and hands-on workshops to choose from, delegates could select the topics most relevant to their statistical programming experience and interests.

PharmaSUG papers are split into 15 different academic sections, and Cytel was well represented in the Statistics and Pharmacokinetics stream with two of our talented programmers, Chris Smith and Sharmeen Reza, presenting separate papers.

We are delighted to announce that Chris Smith, Senior Statistical Programmer was awarded best paper in his stream. The winning paper Multiple Imputation: a Statistical Programming Story was co-authored with industry colleague Scott Kosten.

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Topics: Statistical Programming, biostatistics, SAS, careers


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


Case Study: From Trial Design to CDISC Submission

Posted by Cytel

May 17, 2017 7:22:51 AM

This new case study shares how Cytel supported a specialist biopharmaceutical company from Phase 2 trial design through to an FDA submission for their lead product candidate. We assembled an expert multidisclipinary team of data coding specialists, biostatisticians, statistical programmers and medical writers to support a number of the studies in the ongoing program, including pivotal Phase 2b and 3 trials, and the subsequent creation of the Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE). 

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Topics: Statistical Programming, Case Study, biostatistics, CDISC


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


Case Study: Redesigning a Pragmatic Trial in Oncology

Posted by Cytel

Apr 28, 2017 9:42:44 AM

In this blog we share a case study in which our statistical consulting team helped a client redesign an oncology pragmatic trial to address regulatory agency questions.

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Topics: Oncology, Regulation, biostatistics, real world evidence


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


Trends in Model-Informed Drug Development: Our ASCPT Takeaways

Posted by Cytel

Apr 19, 2017 5:19:08 AM

The ASCPT is the largest scientific and professional organization serving the disciplines of Clinical Pharmacology and Translational Medicine, and its annual conference is one of the most important events on the calendar for those involved in Quantitative Pharmacology and Pharmacometrics (QPP).  Cecilia Fosser, Nand Kishore Rawat and Tina Checchio represented Cytel’s expanding QPP team at this year’s event in Washington DC. In their experience, the meeting represents an excellent opportunity to keep up to speed with new trends and techniques within the space, and the quality of presentations is consistently high.  In this synopsis, we summarize some of the particular highlights from the sessions that our team members attended, along with other takeaways from the event.

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Topics: Early Phase Trials, Phase 3, pharmacometrics, biostatistics, pharmacology


FDA 22 Case Studies and Mitigating Phase 3 Risks

Posted by Cytel

Apr 11, 2017 10:29:00 AM

In a January 2017 paper (1), the FDA reviewed 22 case studies where promising Phase 2 trials did not result in efficacy, safety or both being confirmed in a Phase 3 trial.

At the outset, the authors of the paper are careful to state that the aim is not to assess why these unexpected results occurred, but rather to demonstrate how different trials contribute to developing our scientific understanding of the product.

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Topics: Clinical Development Strategy, Phase 3, Adaptive Clinical Trials, adaptive sample size re-estimation, biostatistics, adaptive designs


Better Management and Outputs in Statistical Programming

Posted by Cytel

Apr 5, 2017 11:39:42 AM

Statistical programmers at all levels can make a significant impact on streamlining delivery, improving efficiency, and importantly ensuring quality.  At a recent PhUSE Single Day event , Cytel's Sunil Gupta gave a very well received presentation on how best to achieve high quality deliverables while maintaining efficiency, noting that 3 key components should be observed:

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Topics: Statistical Programming, biostatistics, Biometrics


New Publication: Design and Monitoring of Multi-Arm Multi-Stage Clinical Trials

Posted by Cytel

Mar 29, 2017 8:29:00 AM

With an increasing interest in platform designs and other innovative designs that involve multiple comparisons over multiple stages, the importance of Multi-Arm Multi-Stage ( MAMS) designs is set to rise.

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Topics: Adaptive Clinical Trials, Multi-Arm Studies, Multi-Arm Multi-Stage Studies, biostatistics, adaptive designs


Case Study: Improving Go/No-go Decision-Making with Custom Software

Posted by Cytel

Mar 24, 2017 9:27:00 AM

 Robust go/no-go (GNG) decision-making is essential for effectively managing risk across a clinical portfolio. In early phase development, it is particularly important to have the correct tools in place to terminate ineffective compounds quickly, while accelerating promising ones through the process. 

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Topics: Bayesian Methods, Case Study, go-no-go, biostatistics, Bayesian, custom software


Setting the Right Foundations: The Role of the Independent Randomization Center

Posted by Liz Cole

Mar 20, 2017 9:54:00 AM

 In the randomized clinical trial (RCT), the process of deciding the randomization method and implementing is critically important. Unfortunately, it is not unheard of for problems to arise. In an article (Downs et al 2010 1), it is noted that as well as initial errors of trial design, problems can arise from errors with programming of the randomization or even human error during the course of the trial. Maintaining the rigor of the RCT relies on robust and reliable randomization with no errors. If treatment allocation is inadequately concealed then overestimation of treatment effect can occur, and the ‘randomized’ control trial becomes effectively ‘non-randomized’ – putting the entire study at risk (2).

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Topics: Clinical Research Services, biostatistics, randomization


The Data Management Plan Takes Center Stage- why is it so important?

Posted by Cytel

Mar 15, 2017 8:51:00 AM

 

A precise and thorough approach to planning is key for success in data management.

The Data Management Plan (DMP) is a critical document in any data management project. It outlines all of the data management work to be done, the timelines and milestones to be achieved, as well as the outputs to be produced. The DMP lets all of the stakeholders know what to expect, how to expect it and when to expect it.

The Society for Clinical Data Management (SCDM)‘s publication, Good Clinical Data Management Practices (GCDMP) (1), provides a complete chapter on Data Management Plans. (The GCDMP is available, even to non-members of the society, at their webpage).   It is important to note that while DMPs are not regulated documents, they are in fact so commonly used across the industry they have become auditable, and therefore scrupulously close attention needs to paid to getting them right.

We outline 4 key points to bear in mind when creating or reviewing a Data Management plan.

Use a Standard Template for Consistency 

To a great extent, the DMP can, and should be standardized across projects for a consistent approach. When using a centralized biometrics model, where data services( data management, statistics, statistical programming) are conducted by a single provider, the development of such standard documents can represent an efficiency in the study set up, and also reduce the oversight burden for the sponsor.  Indeed, for any trial project, a robust Data Management Plan template provides a solid starting point.   One of the important challenges facing industry professionals today is the increasing complexity of clinical trials, and as such, great care needs to be taken to ensure the DMP accurately documents what actions will be taken with the trial data.  Having a highly experienced data management team working on your project, with a track record of implementing innovative and complex trial designs, therefore, becomes increasingly important in this environment. 

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Topics: Data Management, Clinical Research Services, outsourcing, Clinical Data, data manager


Flexible approaches to Biosimilars Development

Posted by Cytel

Mar 10, 2017 7:19:33 AM

 At the recent Biosimilars Summit in Philadelphia, Cytel's Pantelis Vlachos presented on statistical challenges and flexible approaches in biosimilar development.  In this blog we summarize some of the challenges and share the slides from talk.

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Topics: Oncology, Phase 3, adaptive sample size re-estimation, biostatistics, Biosimilars


Case Study: Bayesian Decision-Making in a Phase 3 Oncology Design

Posted by Cytel

Mar 2, 2017 8:45:00 AM

We continue our case study series with this example of a Phase 3 design that uses Bayesian decision making combined with frequentist final analysis.

Clinical Development Background

Our biopharmaceutical client’s lead drug candidate is a late clinical-stage cancer immunotherapy for treatment of a rare oncology indication.  Clinical development of therapies in this indication faces inherent challenges of patient recruitment and scarcity of data.

Sponsor Challenge

The sponsor had previously conducted a randomized, double-blind, placebo-controlled Phase 2 study. Moving into a confirmatory clinical trial setting, they came to Cytel for support with a trial design to address their key questions:

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Topics: Oncology, Bayesian Methods, Phase 3, adaptive sample size re-estimation, biostatistics, adaptive trials, Bayesian


Estimands 101: Interview with Mouna Akacha

Posted by Cytel

Feb 27, 2017 7:39:00 AM

 

It’s been hard to miss the prevalence of estimand-related discussions in the last year.  This is a topic which is very much at the forefront of statistics discussions right now.  We are lucky enough to welcome Mouna Akacha to the blog to give us the lowdown on estimands and the problems and opportunities they represent for the global biopharma industry. 

Mouna is a Consultant in the Statistical Methodology Group of Novartis Pharma AG, based in Basel, Switzerland. She has a wide range of research interests including topics on missing data, longitudinal data and recurrent event data and is an active participant in the current estimand discussions.

Read on to find out everything you ever wanted to know about estimands but were afraid to ask…..

 

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Topics: Regulation, clinical development, biostatistics


Syntax and Variables in R: A Primer

Posted by Cytel

Feb 21, 2017 9:39:07 AM

 

 In a previous blog, we provided an overview of basic data structures in R.  In this follow up piece, we will provide a snapshot of basic syntax in R for programmers who want to get up to speed in this increasingly important programming language. 

 

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Topics: Statistical Programming, biostatistics, SAS, R


Outsourcing success for emerging biopharma

Posted by Cytel

Feb 15, 2017 9:33:05 AM

Outsourcing solutions should never be a one size fits all process, and smaller and emerging biopharma companies may  have different priorities and processes when working with external vendors to larger pharmaceutical organizations.

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Topics: outsourcing, Clinical Data, data manager, biostatistics, Biometrics, RFP


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