Addressing Critical Unmet Oncology Needs in the Era of Precision Medicine

Posted by Cytel

May 23, 2018 12:21:00 PM

 

 

Our Industry Voices series showcases our clients’ innovative work and breakthrough therapeutics in oncologic indications and other critical areas of medical unmet need.

In this article, we sit down with Charles Theuer, M.D., CEO of TRACON Pharmaceuticals to discusshis work, his views on the key advancements in oncology development, the unmet needs yet to be overcome, and the importance of...

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


Rewriting the oncology textbook with cell-based immunotherapies

Posted by Cytel

May 16, 2018 11:00:00 AM

 

Our Industry Voices series showcases our clients’ innovative work and breakthrough therapeutics in oncologic indications and other critical areas of medical unmet need.

In this article, we are delighted to share an interview with Kurt Gunter, M.D., Chief Medical Officer of Cell Medica in which he discusses his work, his views on the key advancements in oncology development, the unmet needs...

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


Innovative Oncology Trial Designs in Practice

Posted by Cytel

May 9, 2018 10:22:00 AM

As we prepare to head to ASCO in under a month's time, we are pleased to share a new ebook that showcases some key applications of innovative trial designs in the oncology development space.

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


Career Perspectives: Interview with Omar Sefiani, Principal Statistical Programmer

Posted by Cytel

Apr 28, 2018 9:50:00 AM

Cytel has industry-leading experts in Statistical Programming, our programmers have years of SAS® Programming expertise, combined with in-depth knowledge of the specific clinical subject matter, which allows for competent and on-time completion of tasks.

In this blog, we talk to Omar, who is based in Geneva to find out more about his career path, current role at Cytel and his interests outside...

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Topics: Statistical Analysis, careers, clinical research, Statistical Programming, CRO, Recruitment, clinical trials, CDISC, Phase 3, Trial Design


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...

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


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...

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


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...

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


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...

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


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


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...

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


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...

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Topics: Oncology, Dose-Escalation, Dose-Finding, biostatistics, adaptive trials, Interim Analyses, Phase 1, phase 2, Phase 3, Early Phase 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: biostatistics, Cytel Strategic Consulting, Enrichment, patient enrollment, adaptive trials, Oncology, Phase 3, personalized medicine


Simulations to optimize clinical trial programs

Posted by Cytel

Oct 11, 2016 9:31:00 AM

Its important to take a strategic  approach to clinical development  in order to minimize the potential for Phase 3 attrition. The below infographic, previously published on the blog highlights some of the approvability and economic reasons cited for Phase 3 failure , and the clinical development issues which may have had an impact. 

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Topics: Clinical Development Strategy, phase 2, Phase 3, Dose Selection, Simulations


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...

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


Case Study:Exposure Response Modeling in Hematology

Posted by Cytel

Sep 13, 2016 10:15:00 AM

 

Exposure-response data gained from clinical studies can provide a basis for model-based analysis and simulation, helping to predict the expected relationships between exposure and response.  Using this approach, it may be possible to optimize dosage regimens and to individualize treatment in specific patient subsets for which there are limited data.  In this blog, we examine a case study of...

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Topics: biostatistics, Phase 3, Cytel Strategic Consulting, pharmacology, pharmacometrics, PK/PD


Case Study:Seamless Phase 2/3 Design in Rare Disease

Posted by Cytel

Sep 9, 2016 9:24:00 AM

 

Challenge:

Our client, an emerging biotechnology company, was preparing for the next stage of development for their novel compound in a rare disease.  They had two major concerns which they wanted the clinical trial design to address- an anticipated difficulty in recruiting subjects to the trial, and  the cost and time investment associated with running separate phase 2 and phase 3 trials. ...

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Topics: biostatistics, adaptive trials, EAST 6.4, Seamless designs, phase 2, Phase 3, Clinical Research Services, Cytel Strategic Consulting


Adaptive Design in the limelight with NEJM article

Posted by Cytel

Jul 18, 2016 8:00:00 AM

In order for adaptive designs to reach their potential, it’s critical that knowledge is effectively dissemirnated within the medical research community – in particular detailed information about the operating and statistical characteristics of specific designs and insights as to their benefits and limitations. 

Cytel recently announced the publication of an important article in the New England...

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Topics: biostatistics, adaptive designs, Adaptive Clinical Trials, sample size re-estimation, phase 2, Phase 3, Seamless designs


What's the price of pharma innovation?

Posted by Cytel

Apr 5, 2016 4:00:00 PM

 

 

Cost of pharmaceutical development and R&D productivity is an ongoing industry concern, consistently discussed in the mainstream and specialist press.  The issue is held in delicate balance against the increasing pressure on pharmaceutical pricing and cost containment measures.

A study by Tufts Center for the Study of Drug Development published earlier this year in the Journal of Health...

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Topics: Phase 1, Program and Portfolio Optimization, Phase 3, phase 2, go-no-go, clinical development


Seamless Adaptive Clinical Trials: Now that we get the statistics, what’s really at stake?

Posted by Esha Senchaudhuri

May 20, 2015 5:56:47 PM

Seamless adaptive clinical trials have gained popularity for reducing the projected time it takes to complete the process of drug development.  However, a study by Cuffe et al., shows that despite a tremendous amount of statistical knowledge about seamless trials, sponsors remain unsure about how to calculate the financial and operational costs of a seamless clinical development program [1]....

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Topics: Phase 1, Early Phase Trials, Clinical Development Strategy, Phase 3, Adaptive Clinical Trials, phase 2


Why Drugs Fail in Phase 3: A Cytel Infographic

Posted by Esha Senchaudhuri

Jan 20, 2015 10:30:03 AM

According to a recent Cytel Whitepaper on Adaptive Clinical Trials, 50% of Phase 3 trials eventually fail. This new Cytel Infographicoffers a breakdown of why so many drugs fail in Phase 3.

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Topics: Early Phase Trials, Clinical Development Strategy, Phase 3


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