Opportunities of FDA’s Complex Innovative Trial Design Pilot Meeting Program

Posted by Cytel

Sep 7, 2018 9:55:00 AM

 

On August 29th 2018, the FDA announced (1) that it would be establishing a Complex Innovative Trial Design (CID) Pilot Meeting Program. This follows the release earlier in August of a draft guidance (2) to help advance effective and innovative clinical trial designs early in drug development that can expedite new cancer therapies.

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Topics: Oncology, FDA, adaptive sample size re-estimation, biostatistics, adaptive trials, Seamless designs


Career Perspectives: Interview with Benjamin Esterni, Principal Biostatistician

Posted by Cytel

Mar 16, 2018 7:00:00 AM

At Cytel we believe that expert statistical input has the power to shape the future of clinical development: de-risking portfolios, accelerating timelines, and increasing the probability of success.

In this blog we talk to Benjamin who lives in France, to find out more about his career path, achievements, current role at Cytel and his interests outside of work. 

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Topics: Recruitment, Cytel Strategic Consulting, Statistical Programming, Statistical Analysis, clinical development, biostatistics, adaptive designs, adaptive trials, careers, clinical trials, CRO, clinical research


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


Recent Publication: A Gatekeeping Procedure to Test a Primary and a Secondary Endpoint in a Group Sequential Design with Multiple Interim Looks

Posted by Cytel

Feb 15, 2018 10:35:00 AM

A recent publication in Biometrics ‘A Gatekeeping Procedure to Test a Primary and a Secondary Endpoint in a Group Sequential Design with Multiple Interim Looks’ greatly extends the results of Glimm et al. ( 2010) and Tamhane et al ( 2010) which studied the problem of testing a primary and secondary endpoint, subject to a gatekeeping constraint, using a group sequential design (GSD) with K = 2...

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Topics: Cyrus Mehta, Statistical Analysis, Group Sequential, biostatistics, adaptive trials


Slides: East User Group Meeting and Trial Design Symposium

Posted by Cytel

Dec 4, 2017 11:28:00 AM

In 2011, Cytel organized its first East User Group Meeting (EUGM) in Paris. Since then, we have held an EUGM almost every year, alternating between locations in Europe and North America.  These meetings have been a great success, giving opportunities for customers and industry colleagues to meet each other as well as with key opinion leaders, whilst learning more about our East software and...

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Topics: Cytel Strategic Consulting, Clinical Development Strategy, Adaptive Clinical Trials, Statistical Innovations in Clinical Development, EAST 6.4, adaptive trials


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: 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...

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


Accelerating development with combined SAD/MAD approach

Posted by Cytel

Jan 30, 2017 9:50:24 AM

Single ascending dose (SAD) and multiple ascending dose (MAD) studies are typically the first in human studies.  They seek to gain information on safety and tolerability, general pharmacokinetic (PK) and pharmacodynamic ( PD)  characteristics, and of course identify the maximum tolerated dose (MTD).

Conventionally, SAD  and MAD studies were conducted separately, but increasingly are combined...

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Topics: Cytel Strategic Consulting, Cytel Consulting, Statistical Programming, Phase 1, Dose-Finding, Compass, Phase I, biostatistics, adaptive designs, adaptive trials


How to get the regulatory green light for your adaptive design?

Posted by Cytel

Jan 23, 2017 10:35:00 AM

As a group, Cytel had over 40 successful regulatory interactions last year, many of which supported approvals for innovative trial design approaches.  In this blog we look at some of the key success factors for regulatory interactions regarding adaptive designs.

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Topics: Cytel Strategic Consulting, Cytel Consulting, Regulation, biostatistics, adaptive designs, adaptive trials


Adaptive Design Approaches from Cardiovascular Clinical Trialists Forum

Posted by Cytel

Jan 16, 2017 8:41:00 AM

 The Global Cardiovascular Clinical Trialists Forum is a key event bringing together leading experts from across the spectrum of opinion leaders, clinical trialists, investigators, regulators, statisticians and practitioners to address the most pressing questions in cardiovascular clinical development today.  At the December conference, eminent biostatisticians Cyrus Mehta and Stuart Pocock...

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Topics: Cyrus Mehta, Cardiovascular, Cytel Events, biostatistics, adaptive designs, adaptive trials


Our readers' choice : Top Blog posts from 2016

Posted by Cytel

Dec 23, 2016 8:21:00 AM

 

As we prepare to say 'so long, farewell'  to 2016, we'd like to take the opportunity to thank all our blog readers and subscribers.  Read on for a  round up of our most read topics from the year.... 

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Topics: Clinical Data, EDC, database build, data manager, CDISC, SDTM, adaptive designs, adaptive trials


Adaptive Design CONSORT Extension Project: The Inside Scoop

Posted by Cytel

Dec 15, 2016 11:53:14 AM

In April, we interviewed NIHR research fellow Munya Dimairo about the paper, ‘Adaptive designs undertaken in clinical research: a review of registered clinical trials’ (Hatfield et al, 2016), for which Munya was a co-author. 

During the previous interview, we discussed the barriers to uptake of adaptive designs, and the urgent need for a cross-sector discussion and work on reporting guidance...

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Topics: biostatistics, adaptive designs, 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


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...

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


New East Insights Video:Creating an SSR Design

Posted by Cytel

Nov 9, 2016 9:03:11 AM

Adaptive sample size re-estimation designs are an important part of the statistician's toolkit. In this first in a series of East Insight videos, Cytel Statistician Charles Liu walks us through the creation of an adaptive sample size re-estimation design in East with a 5 minute demo. Watch the video and download the accompanying slidedeck to recreate the steps. 

 

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Topics: East, sample size re-estimation, adaptive sample size re-estimation, adaptive trials


Pharmacometrics tools of the trade: 4 factors to consider

Posted by Cytel

Nov 1, 2016 10:02:00 AM

Unlike statistics which has been around in some form for hundreds of years, pharmacometrics is, by comparison, a relatively new discipline and only entered the clinical development world in the last 30 years. Situated at the intersection of mathematical modeling, simulation, and big data, pharmacometrics leverages the best practices of translational research to generate clinical development...

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Topics: pharmacometrics, Biomarkers, adaptive trials, pharmacology, PK/PD


Adaptive Designs: A Data Management Perspective

Posted by Cytel

Oct 7, 2016 8:29:00 AM

Adaptive designs have the potential to accelerate clinical development, and improve the probability of trial success. While the principle is simple- to reduce the uncertainty in clinical development by obtaining additional information from the ongoing trial- the statistical methodologies can be complex, and expert support is often required to conduct the clinical trial design. There's also...

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Topics: Data Management, Clinical Development Strategy, Clinical Data, Adaptive Clinical Trials, EDC, data manager, adaptive designs, adaptive trials


Challenges in Neuroscience Clinical Trials

Posted by Cytel

Oct 5, 2016 9:48:00 AM

 While some progress has been made in terms of scientific development in Neuroscience and Neuropsychiatry indications, the pace of translation into more effective treatments  remains elusive.

 At the recent Cytel seminar co-hosted with Pfizer, Abdul J. Sankoh of Sage Therapeutics presented on some of the challenges in these therapeutic areas and discusses strategies moving forward.  He bases...

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Topics: Clinical Research Services, psychiatry and neuroscience, biostatistics, adaptive designs, adaptive trials


Case studies:Learning from less-well understood adaptive designs

Posted by Cytel

Sep 29, 2016 9:28:14 AM

A paper "Best practices case studies for 'less well-understood' Adaptive designs", has been published by the DIA Scientific Working Group on Adaptive Designs as a twin document to the previously discussed "Challenges and Opportunities of 'Less Well Understood' Adaptive Designs".  This publication furthers understanding by reviewing 10 important case studies and sharing details on their design...

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Topics: Rare Disease, Clinical Development Strategy, Adaptive Clinical Trials, Multi-Arm Studies, adaptive sample size re-estimation, Multi-Arm Multi-Stage Studies, EAST 6.4, adaptive designs, adaptive trials, Seamless designs


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


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