Cytel Congratulates Lipopharma and CLINGLIO Consortium on Recent Grant Award

Posted by Cytel

Feb 27, 2018 4:38:00 AM

We extend our congratulations to Lipopharma and the CLINGLIO project consortium on their recent 6,15M€ grant award by the European Union’s Horizon 2020 program. Led by Lipopharma, the multinational consortium brings together 12 academic and industry organizations from Europe, Israel, and the USA.

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Topics: Oncology, Trial Design, adaptive trials, personalized medicine


Round-Up:The 6 Hottest Blog Topics from 2017

Posted by Cytel

Dec 21, 2017 6:44:00 AM

As we prepare to close the door on 2017, we thought we would take a look back at the  topics which have been most popular on the Cytel blog this year.  It's an interesting insight on what pain points and opportunities feature highly on our global biopharma audience's radar.  Read on to learn which of our 2017 blogs have received the most interest from our audience so far.

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Topics: Oncology, Data Management, Cytel Strategic Consulting, Statistical Analysis, Trial Design Software, pharmacometrics, estimands, NONMEM, data science, R language


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.

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


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.

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


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. 

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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. 

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


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


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


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


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


Innovative Phase 3 Adaptive Enrichment Design in Oncology

Posted by Cytel

Dec 2, 2016 9:19:10 AM

At a recent Pfizer/ Cytel seminar on rare disease and oncology development, Cytel’s Lingyun Liu presented innovative work on a patient enrichment design. In this blog, we share some design and operational considerations. This approach can help mitigate against underpowering of a clinical trial where there is uncertainty and heterogeneity of treatment effect among subpopulations.

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Topics: Oncology, Enrichment, Cytel Strategic Consulting, Phase 3, patient enrollment, biostatistics, adaptive trials, personalized medicine


Practical Challenges of the LUNG-MAP study

Posted by Cytel

Sep 27, 2016 9:24:00 AM

The Lung-MAP  trial is an innovative biomarker driven 'precision medicine' study which evaluates five novel agents for the treatment of patients with advanced squamous cell carcinoma of the lung.  As well as exploring therapeutic options for this indication, it also aims to improve the drug development process. 

At a Cytel seminar earlier in the year, Antje Hoering of CRAB presented to delegates on some of the practical challenges of the Lung-MAP study.

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Topics: Oncology, Precision Medicine, Clinical Development Strategy, Phase 3, phase 2, EDC


Case Study: BLRM for Phase 1/2a Oncology Study

Posted by Cytel

Sep 2, 2016 10:30:00 AM

 

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Topics: Oncology, Dose-Escalation, East ESCALATE, CRM, Early Phase Trials, Eearly Development, BLRM, biostatistics, EAST 6.4, adaptive trials


Operational and regulatory considerations in a promising zone trial

Posted by Cytel

Aug 9, 2016 9:00:00 AM

At the recent JSM Meeting, Cytel’s Yannis Jemiai presented the case study of the VALOR trial which used a promising zone design. At the time of the study, existing therapy for relapsed or refractory AML was generally unsatisfactory with no approved drugs available for patients, and a very poor prognosis.  Vosaroxin was a first-in-class anticancer quinolone derivative which had previously been studied in a single arm Phase 2 study. In this blog we'll take a look at the operational and regulatory considerations in the implementation of this trial, which were highlighted during Jemiai's talk. 

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Topics: Oncology, Clinical Research Services, Regulation, ACES, biostatistics, adaptive designs, adaptive trials, DMC


Webinar Replay: Single and Double Agent Dose Escalation Designs

Posted by Cytel

Jul 21, 2016 6:30:00 AM


Did you miss our webinar on Single and Dual Agent Dose escalation designs earlier in the year?  In this blog we have made the replay available for your review, and  also  take the opportunity to recap key reasons why you should consider a model based design for your dose escalation study.

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Topics: Oncology, Dose-Escalation, Bayesian Methods, EAST 6.4


5 session picks for the JSM

Posted by Cytel

Jul 20, 2016 8:30:00 AM

The Joint Statistical Meetings is the largest and arguably most highly respected gathering of statisticians in the world.  It will bring together over 6000 statisticians for this year’s event in Chicago.   As a large meeting, it can be a challenge to navigate and find the sessions which are going to be most valuable for your work.  To help out, we've asked some of the leading lights of our statistical group which sessions are their top picks this year. 

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Topics: Oncology, Trial Design, biostatistics, adaptive trials, Biometrics, JSM


Overcoming Data Management Challenges in Oncology Studies

Posted by Cytel

Apr 26, 2016 11:30:00 AM

In this blog we’ll highlight some unique challenges that are encountered from a Data Management perspective when working on early phase Oncology trials. We’ll also discuss approaches which can be employed to mitigate these issues.  

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Topics: Oncology, Data Management, Clinical Research Services, Phase 1, Clinical Data, phase 2, EDC, database build, data manager, CDM, Biometrics


Dual Agent Dose Escalation Designs

Posted by Cytel

Apr 22, 2016 9:30:00 AM

FDA draft guidance on “Co development of two or more unmarketed investigational drugs for use in combination”  notes that:

“Combination therapy is an important treatment modality in many disease settings, including cancer, cardio-vascular disease, and infectious diseases. Recent scientific advances have increased our understanding of the pathophysiological processes that underlie these and other complex diseases. This increased understanding has provided further impetus for new therapeutic approaches using combinations of drugs directed at multiple therapeutic targets to improve treatment response or minimize development of resistance.” In this setting, it’s important to be able to design dose escalation studies which can identify the synergistic activity of compounds, and less toxic combinations.  

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Topics: Oncology, Phase 1, Early Phase Trials, Adaptive Clinical Trials, BLRM, Bayesian, PIPE


HTAs: Adjusting Overall Survival for Treatment Switch

Posted by Cytel

Apr 13, 2016 11:00:00 AM

 

We continue our series of blogs covering the expert presentations from the EAST User Group Meeting. Consultant Claire Watkins of Clarostat provided a different statistical focus, moving the discussion to a later point in the product lifecycle and the area of Health Technology Assessment.  Her presentation, which tackled the topic of Adjusting Overall Survival for Treatment switch, shared the recommendations of a cross-institutional statistical working group ( Sub team of the PSI HTA Special Interest Group). 

Statisticians have crucial role to play in the area of health economics and health technology assessments since payers like regulators require submissions which are robust and evidence based.  However there are key differences in the perspectives of regulators and HTA agencies posing different challenges for statisticians involved in such submissions.

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Topics: Oncology, FDA, NICE, HTA, health economics, treatment switch


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