The Rise of R-should SAS programmers get up to speed?

Posted by Cytel

Jun 29, 2016 8:00:00 AM

 

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Topics: biostatistics, R programming, Simulations, SAS, Statistical Programming


Getting the best out of your biometrics RFP

Posted by Cytel

Jun 23, 2016 7:21:06 AM

 

Vendor selection is a critical component of ensuring clinical trial success.  A 2015 report (1)  suggested that clinical outsourcing penetration will reach 72% by 2020- nearly 3 quarters of all clinical trials will be outsourced to professional CROs.  The process of vendor selection and management may be managed by the clinical operations teams within smaller companies, or by outsourcing and...

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Topics: Clinical Research Services, outsourcing, Clinical Development Strategy, EDC, database build


Sharpening your Advanced SAS Skills: Interview with Sunil Gupta

Posted by Cytel

Jun 21, 2016 10:30:00 AM

Sunil is an Associate Director of Statistical Programming at Cytel and has over twenty-five years of experience in the pharmaceutical industry.  He is also an international speaker and best-selling SAS author.  Most recently, Sunil contributes his knowledge as a CDISC Oncology ADaM reviewer and has taught his CDISC online classes with the University of California at San Diego.  Sunil has MS in...

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Topics: Statistical Programming, Training and Education, biostatistics, SAS


Determining the future course of your trial

Posted by Cytel

Jun 16, 2016 10:23:00 AM

 Predicting the course of a clinical trial is something which people will always want to do-whether for statistical reasons, planning reasons or business reasons. In this blog we look at examples of where prediction goes off course, and how we can resolve these issues.  We also share valuable video and slidedeck resources from our VP Consulting and Software, Yannis Jemiai.

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Topics: East, East PREDICT, Interim Analyses, Cytel Videos, Cytel Events, clinical development, EAST 6.4, adaptive designs, adaptive trials, DMC


Managing DMC analysis- an innovative programming solution

Posted by Cytel

Jun 14, 2016 8:00:00 AM

At Cytel, we are very often asked to get involved in DMCs ( Data Monitoring Committees)  in a variety of capacities. Our statistical experts are recognized for their work in many of the areas related to DMCs including-group sequential and adaptive designs, multiplicity, missing data, and decision sciences.  One key operational management issue when producing analysis for DMCs  is that rules...

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Topics: Clinical Research Services, Statistical Programming, Interim Analyses, Blind and Unblind Trials, Clinical Data, ACES, biostatistics, DMC


How can the CMO/Biostatistician connection improve clinical development?

Posted by Cytel

Jun 7, 2016 8:00:00 AM

 At the recent CMO Summit East  James ( Jim) Bolognese, Cytel’s Senior Director of Strategic Consulting, and Lou Vaickus,MD, FACP, Founder and President of aktaPD jointly explored how the critical connection between a CMO and a biostatistician can help enhance communication with internal and external stakeholders, ensure patient safety and ultimately improve clinical development efficiency....

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Topics: Clinical Development Strategy, go-no-go, clinical development, biostatistics, p value


EAST 6.4 Release: Interview with Yannis Jemiai

Posted by Cytel

May 31, 2016 7:30:00 AM

 

Last week, we were delighted to announce the release of East 6.4 bringing further cutting –edge approaches to the East user community. East is the industry standard platform for clinical trial design, simulation, and monitoring, improving scientific productivity during the critical planning stages of clinical development. In this blog we catch up with Yannis Jemiai, VP of Cytel  to gain some...

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Topics: East, Bayesian Methods, East PREDICT, Prediction, Software Simulations, Multi-Arm Studies, Multi-Arm Multi-Stage Studies, biostatistics, EAST 6.4, adaptive trials


Highlights from the PSI Conference

Posted by Cytel

May 26, 2016 11:37:20 AM

A number of the Cytel team were in Berlin 22nd- 25th May  for the PSI Annual conference.  The PSI Conference is an important forum for statisticians and we found this year's event to be energetic, technically interesting and well attended.  In this blog, we’ll summarise some of the particular highlights from the sessions that our team members attended.

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Topics: Clinical Data, biostatistics, adaptive designs, adaptive trials, PSI Conference


Pattern Recognition and 'Big Data'

Posted by Cytel

May 19, 2016 6:00:00 AM

The explosion in healthcare information and “big data “has been one of the most written about topics in the last few years. These big data in the form of electronic health records, diagnostic tests, genomics, proteomics, not to mention data from wearable devices and apps have the potential to transform healthcare.  That potential can only be realized though through the application of advanced...

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Topics: Bayesian Methods, Computing, Clinical Data, biostatistics, machine learning, big data, pattern recognition


Scrambled Data – A Population PK/PD Programming Solution

Posted by Cytel

May 17, 2016 8:30:00 AM

Cytel participated at PharmaSUG 2016 in Denver recently.  A key event on the statistical programming global calendar, the topics included Submission Standards, Application Development and Data Visualizaton. Sharmeen Reza, Associate Director Statistical Programming at Cytel was selected to present a paper presentation in the Statistics and Pharmacokinetics stream on the topic of Scrambled Data-...

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Topics: Statistical Programming, pharmacometrics, biostatistics, pharmacology


Lost in Traceability- From SDTM to ADaM

Posted by Cytel

May 12, 2016 10:18:00 AM

 

Once upon a time Hansel and Gretel laid a trail of breadcrumbs which they followed to find their way back home.  Their story can be an allegory for the concept of traceability in clinical data where we need to  lay a clear path to ensure that the results we have created can be reproduced. This blog looks at some aspects of a presentation Lost in Traceability  by Angelo Tinazzi at the CDISC...

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Topics: Clinical Research Services, Statistical Programming, FDA, Clinical Data, CDISC, SDTM, ADaM, EMA, PMDA, Biometrics


Subgroup Analyses in Early Phase Clinical Trials

Posted by Cytel

May 10, 2016 8:00:00 AM

 

We were fortunate to welcome Björn Bornkamp of Novartis to the EUGM 2016 presenting work he has developed jointly with Marius Thomas (1) on methods of adjusting treatment effect estimates in subgroup analyses with a focus on early phase trials.   

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Topics: Early Phase Trials, clinical development, biostatistics, subgroup analysis


5 Hot Topics from the CDISC EU Interchange

Posted by Angelo Tinazzi

May 4, 2016 7:00:00 AM

Last week was the CDISC EU Interchange conference in Vienna, a key event on the calendar for Cytel’s statistical programming subject matter experts . Angelo Tinazzi, Director, Statistical Programming, Clinical Data Standards and Clinical Data Submission at Cytel co-chaired the sessions on Foundational Standards and Standards Governance alongside Astrazeneca’s Daniel Graham, and delivered a...

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Topics: Clinical Research Services, Statistical Programming, FDA, Clinical Data, CDISC, SDTM, ADaM, EMA, PMDA, Biometrics


Adaptive Designs in Practice

Posted by Cytel

Apr 28, 2016 12:30:00 PM

Adaptive Designs in Practice: Interview with NIHR Research Fellow Munya Dimairo

NIHR and University of Sheffield researchers recently published a paper, ‘Adaptive designs undertaken in clinical research: a review of registered clinical trials’(Hatfield et al) which explores the current state of adaptive designs in practice. In this blog we catch up with Munya Dimairo, NIHR Research fellow and...

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Topics: Group Sequential, Adaptive Clinical Trials, adaptive sample size re-estimation, adaptive designs, adaptive trials


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...

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


Handling CDM data integrations

Posted by Cytel

Apr 20, 2016 8:00:00 AM

During the course of any clinical trial, there are often data which, while collected electronically, are outside of the scope of the eCRF . These data include central lab results like ECGs, PK/PD data and others. In this blog we’ll take a look at some key considerations in handling electronic data transfers and any subsequent integration with the core EDC database.

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Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, CDM


5 Key Interactions of Clinical DM and Statistics

Posted by Cytel

Apr 15, 2016 9:00:00 AM

It's critical for biostatistics and data management to be closely aligned and working effectively together. The consequences when these biometrics teams aren't integrated can be significant-  impacting on both efficiency and data quality.  If data is collected and cleaned without the input of statistics, the assumptions which have been made may not be adequate, resulting in additional work and...

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Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, CDM, Biometrics


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...

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


Blinded SSR in early phase biosimilar studies

Posted by Cytel

Apr 7, 2016 10:30:00 AM

 

 Francois Beckers, Global Head of Biostatistics & Epidemiology at Merck KGaA joined us at the East User Group Meeting in March and presented case studies of Merck KGaA’s experiences with Blinded Sample Size Re-estimation in early phase studies, more specifically in the context of biosimilar studies.

 

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Topics: sample size re-estimation, Cytel Consulting, Cytel Videos, Phase 1, Early Phase Trials


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