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


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...

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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...

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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....

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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...

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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...

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


EnForeSys® enrollment forecasting showcases at SCOPE

Posted by Cytel

Feb 17, 2016 12:32:45 PM

Charles Liu, Statistician and Product Manager at Cytel will be part of the expert speaker panel at the 7th Annual SCOPE Summit on 23-26th February. This year’s meeting is taking place in Miami, and offers a packed program with tracks covering such varied topics as risk based monitoring, clinical data technology and integration, and managing outsourced clinical trials. SCOPE has become one of the...

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Topics: feasibility studies, patient enrollment, enforesys, Scope conference


"Data Standards and My Experience" - Reflections from Sangeetha Gandepalli

Posted by Sangeetha Gandepalli 

Dec 3, 2015 2:30:17 PM

On Dec. 12, 2015 Sangeetha Gandepalli, a Technical Lead in Clinical Data Management at Cytel, will speak before SCDM India. Here is a preview of her talk entitled "Data Standards and My Experience." 

Data standards play a key role in improving the efficeincy and quality of health care delivery. Without data standards organizations cannot readily share clinical information and medical care becomes...

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How to Make the Most of Data Management Capabilities for Improved Risk Based Monitoring

Posted by Cytel

Dec 1, 2015 3:00:00 PM

Risk based monitoring is a strategic monitoring practice which aims to shine the spotlight on problematic study areas, to maximize oversight of the most vulnerable data. The efficiency promised by RBM arises from the ability to detect the sources of data require the most attention, and distribute finite resources for oversight to the most problematic areas. This distribution aims to optimize...

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Topics: Data Management, Clinical Data, Risk Based Monitoring


A Competitive Alternative to Model-Based Dose-finding

Posted by Cytel

Nov 19, 2015 4:00:00 PM

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Topics: Dose-Finding, BLRM


Takeda Pharmaceuticals' Ling Wang Talks Model-based Dose-finding Designs

Posted by Cytel

Nov 16, 2015 4:30:00 PM

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Topics: Dose-Finding, BLRM


2 Talks on Early Phase Go/No-GO Decision Making

Posted by Cytel

Nov 12, 2015 4:00:00 PM

Last week Cytel joined forces with Sanofi/Genzyme to devote a full day of workshops and talks related to modern methods in early phase oncology. Patrick Mitchell, an Associate Director of Statistical Sciences at Astra Zeneca, gave this talk on Bayesian go/no-go decision-making in an early phase oncology event study. 

Astra Zeneca recently invited Cytel to take part in a collaborative initiative...

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Topics: Bayesian Methods, Early Phase Trials, Clinical Development Strategy, go-no-go


Bayesian Dose Escalation Designs for Late Onset Toxicity

Posted by Cytel

Nov 10, 2015 4:00:00 PM

Last week Cytel joined forces with Sanofi/Genzyme to devote a full day of workshops and talks related to modern methods in early phase oncology. 

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Topics: Dose-Escalation, Bayesian Methods


The 24 Hour Work Day

Posted by Esha Senchaudhuri

Nov 5, 2015 3:34:15 PM

Oftentimes people perceive a tradeoff between speed and quality. The faster you do something the more likely you are to make mistakes. Then again, checking everything carefully means things take a longer time.

Right?  

What if you could promise a team that could work 24-7?

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Topics: Data Management, Clinical Research Services, Clinical Development Strategy


Quantitative Pharmacology & Pharmacometrics for Biomarker Driven Clinical Strategy

Posted by Esha Senchaudhuri

Nov 3, 2015 6:14:50 PM

QPP (sometimes called QP2) remains at the heart of model based drug development. Short for Quantitative Pharmacology & Pharmacometrics, it refers to several types of quantitative modeling including meta-analysis, PK/PD , statistical modeling and the modeling of go-no-go decision rules.

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Topics: Simulation & Biomarkers, pharmacometrics, Biomarkers


How to Reduce Bias in the Estimates of Count Data Regression

Posted by Cytel

Oct 29, 2015 4:00:00 PM

A common challenge of working with small sample sizes is determining proper bias correction methods when evaluating a given set of data. Oftentimes, statisticians depend on large sample sizes to naturally correct for any bias. Small sample sizes, by contrast, require innovations like Firth’s famous bias correction method.

Recently, Cytel statisticians Ashwini Joshi and Sumit Singh gave a talk...

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Topics: Access to Slides PDF, Small Sample Sparse Data


P-Values & Pharma Development: We Want to Hear from You

Posted by Esha Senchaudhuri

Oct 27, 2015 6:04:00 PM

Here at Cytel we have enjoyed following the debates on the p-value controversy currently taking place on the ASA website, and indeed debating the issue ourselves. While we plan to post our views on the topic in the weeks to come, we would like to invite your thoughts on the issue as well. 

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Topics: Bayesian Methods, Statistical Analysis


Cytel Case Study Series III: Dose Finding & Dose Response Modeling in Pediatric Asthma

Posted by Cytel

Oct 22, 2015 2:28:53 PM

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Topics: Case Study, Pediatric, MCP-Mod


3 Statistical Challenges for Pooling Phase 1 Data

Posted by Esha Senchaudhuri

Oct 19, 2015 5:15:40 PM

It is often necessary to pool safety data from late phase studies, in preparation for regulatory submission. Some of our clients have also begun to add Phase 1 safety data to this pool. On some occasions this is required by regulators. In many cases, however, these Phase 1 data simply provide further evidence that a new therapeutic lives up to the promise of safety across patient populations.

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Topics: Data Management, Safety, Early Phase Trials, Small Sample Sparse Data


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