Collaboration Brings Success for the UK Adaptive Designs Working Group.

Posted by Cytel

Jul 11, 2017 6:57:00 AM

The Adaptive Designs and Multiple Testing Procedures Workshop (ADMTP), the first joint meeting of the Adaptive Designs Working Group of the MRC Hubs for Trials Methodology Research and the joint ADMTP Working Group of the International Biometrics Society German and Austro-Swiss Regions, took place in Cambridge, UK last month. 

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Topics: Clinical Data, Adaptive Clinical Trials, biostatistics, adaptive designs


When Biostatisticians Disagree About Ethics

Posted by Cytel

Jul 6, 2017 9:09:00 AM

 By Esha Senchaudhuri

The ethical benefits of adaptive clinical trials have been widely acclaimed: higher prospects for patients to be enrolled into the correct trial arm [1]; shorter trials for the most effective new therapies (see the early stopping outcome of the MUSEC trial) [2]; and enrollments commensurate with the needs of research, i.e. the last patient enrolled is not superfluous to a trial’s outcomes (e.g. according to one clinical biostatistician, “trial designs that learn more and treat better with less burden and sacrificing of patients”) [3].

However, the acknowledgement that ethical benefits exist is a separate question from the degree to which they exist when compared to a more traditional design.

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Topics: Regulation, patient enrollment, Adaptive Clinical Trials, biostatistics, medical ethics


Under wraps: the importance of patient privacy

Posted by Manjusha Gode

Jun 28, 2017 4:36:40 AM

About the Author: Manjusha Gode has over 28 years' IT experience spanning delivery Management, quality management, software testing,  people management, process improvement and multi-locational operations.  She is a pioneering member of Cytel's clinical programming team.

 Clinical data transparency improves decisions for all healthcare stakeholders including patients, caregivers, healthcare providers, payers, and regulators.

The topic of transparency and the process by which clinical trial data can be effectively anonymized and disclosed for use by researchers has become a hot topic in recent years. In this blog, we will discuss the broader context of patient privacy and the key considerations for biopharmaceutical companies in this area.

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Topics: Clinical Research Services, Regulation, Statistical Programming, biostatistics, CDISC


Join us for the East Symposium and User Group Meeting

Posted by Cytel

Jun 26, 2017 8:28:03 AM

Since 2011 we have been celebrating Cytel's birthdays by holding an East Annual Symposium and User Group Meeting ( EUGM), alternating locations between Europe and the United States. Our keynote speakers have featured some of the industry's most eminent biostatistics thought leaders including Stuart Pocock, Dave DeMets, Chris Jennison, Sue Todd, and Franz Koenig.  Each annual event has been a great success with a  mix of scientific presentations, animated discussion, round tables and pre-conference software workshops. 

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Topics: East, Dose-Escalation, Adaptive Clinical Trials, Multi-Arm Multi-Stage Studies, biostatistics, EAST 6.4, adaptive designs


Cytel ASCO 2017 Report

Posted by Cytel

Jun 20, 2017 7:17:47 AM

 At ASCO 2017, Cytel trial design experts joined our medical and academic colleagues to share the most recent innovations in cancer research.
In this blog we will share the abstract and pdf of the poster presentation: TAPPAS: Adaptive enrichment phase 3 trial of TRC105 and pazopanib versus pazopanib alone in patients with advanced angiosarcoma (AAS), co-authored by Cytel's Cyrus Mehta and Lingyun Liu with TRACON Pharmaceuticals.  

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


Poster: Model Based Predictions of Pharmacodynamic Responses in Ulcerative Colitis Patients

Posted by Cytel

Jun 12, 2017 12:30:00 PM

The Population Approach Group in Europe (PAGE) represents a community with a shared interest in data analysis using the population approach. Each June, a meeting of the community is held at a different European location. At this year's meeting in Budapest, Hungary, Cytel's Director of Quantitative Pharmacology and Pharmacometrics, Cecilia Fosser, showcased innovative work on creating model based predictions of pharmacodynamic responses in ulcerative colitis patients.  Fosser presented a poster Model based predictions of the PTG-100 pharmacodynamic responses in ulcerative colitis patients created in collaboration with colleagues from Protagonist Therapeutics. 

In this blog we share the abstract and link to access an electronic copy of the poster . 

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Topics: Statistical Analysis, pharmacometrics, Simulations, biostatistics, pharmacology


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


Highlights from the PSI 2017 Conference

Posted by Cytel

Jun 1, 2017 8:06:00 AM

A number of the Cytel team were in London, 14th – 17th May 2017 for the PSI Annual conference. The PSI Conference is an important forum for statisticians and we found this year's event insightful, informative and well attended. In this blog, we'll summarize some of the particular highlights from the sessions that our team members attended.

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Topics: Clinical Data, Adaptive Clinical Trials, biostatistics, adaptive designs, PSI Conference


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


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


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