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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 behind-the-scenes insights into the development and  new features of this important release.

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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 analytics to recognize patterns from the vast information available. As such, disciplines such as pattern recognition play a pivotal role in the future of healthcare.

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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- A Population PK/ PD Programming Solution.  The presentation was very popular and well attended, so we've included an abstract of the presentation  below, and made her slides available for download. 

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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 EU Interchange. 

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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


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 one of the paper’s co-authors to find out more.

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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 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


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 compromised timelines.  So, let's take a closer look at 5 important interactions between the two functions during the course of a clinical trial. 

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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 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


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


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 Economics (1) provides new estimates of R&D costs, building on previous work in the area.

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


Decision Making in Early Clinical Development

Posted by Cytel

Mar 29, 2016 11:00:00 AM

On March 16th and 17th the 5th East User Group Meeting took place in London.  This very successful 2 days saw a variety of talks on aspects of clinical trial design innovation.  Over the next couple of weeks, we will be reviewing some of the key topics which were addressed during the meeting.

In this post, we'll take a look at Paul Frewer of Astrazeneca's presentation on Decision Making in Early Phase Clinical Development.  This talk was very well received by the delegates and prompted plenty of discussion afterwards. 

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Topics: Bayesian Methods, Cytel Consulting, Cytel Videos, Phase 1, Early Phase Trials, phase 2


What's the Value of P?

Posted by Cytel

Mar 23, 2016 9:30:00 AM

“How many statisticians does it take to ensure at least a 50% chance of a disagreement about p-values?” 

So questions George Cobb of Mt. Holyoke College in  his commentary on  the ASA’s 7th March ‘Statement  on P Values: context, process and purpose’

The association took the unprecedented step of publishing the statement following a long litany of criticism of misuse of the P value. This included the decision last year by Journal of Basic and Applied Social Pyschology to restrict the publication of papers where hypothesis testing is used for analysis.

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Topics: Bayesian Methods, p value


EAST takes on Multi-Arm Multi-Stage Designs

Posted by Cytel

Mar 11, 2016 12:30:00 PM

There has been increasing interest in  multi-arm multi-stage trials with treatment selection and sample size re-estimation at interim analysis. The East 6.4  release incorporates new Multi-Arm Multi-Stage (MAMS) module to support statisticians designing these studies.  In this blog, we take a high level look at some of the features and advantages of this approach.  

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Topics: East, Adaptive Clinical Trials, Multi-Arm Studies, Multi-Arm Multi-Stage Studies, EAST 6.4


Mind the Gap! How to prepare for SDTM migrations.

Posted by Cytel

Mar 8, 2016 9:30:00 AM

Data standardization is critical to ensure successful regulatory submissions. While many sponsors now choose to create CDISC compliant outputs as part of their in-line study analysis and reporting, inevitably legacy conversion of older studies is required.

A legacy conversion project is one which requires a significant transformation effort, where neither CDASH nor SDTM has been used. Migrating to SDTM is of course a complex activity, requiring a precise and intelligent approach- it’s not just a matter of renaming variables.  A gap analysis which assesses the current state of the data can ensure the project is commenced on the right footing.  In the below example, we conducted a gap analysis as part of a project for a client who engaged Cytel for support with their ISS/ISE.

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Topics: Statistical Programming, ISS, ISE, CDISC, SDTM


Adaptive SSR: Debunking the inefficiency myth

Posted by Cytel

Mar 3, 2016 3:00:00 PM

 'The aim of a discussion should not be victory but progress.'

This principle, expressed by the French essayist Joseph Joubert, applies effectively to the spirit of scientific debate. More specifically, within the clinical development space, the field of adaptive designs has seen its fair share of both discussion and progress. In this blog we’ll take a look at one debated area- the efficiency of Adaptive SSR designs.

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Topics: Cyrus Mehta, Adaptive Clinical Trials, adaptive sample size re-estimation, Lingyun Liu


Getting Technical: The evolving role of the Data Manager

Posted by Cytel

Feb 26, 2016 9:00:00 AM

Remember the early days of Electronic Data Capture? Those first systems, which were revolutionary for their time featured basic data entry screens, simple edit checks and a handful of reports. 

Technology has come a long way since then, and the EDC landscape has matured dramatically along with it.  Current EDC must-haves include easy user and site management, secure automated password retrieval, robust reporting, query and SAE management, as well as Source Data Verification, and Risk based monitoring. Many sites need to be active at the same time; labs need to enter or upload data directly into the system; medical coding should be performed inside of the tool; images need to be uploaded and stored; email and text alerts sent to investigators and sponsors, and patient reported outcomes and diaries need to be available.

Counter intuitively, while EDC system functionality is becoming ever more sophisticated, the interface to build the systems is becoming easier to use and understand.

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


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