Case Study: Improving Go/No-go Decision-Making with Custom Software

Posted by Cytel

Mar 24, 2017 9:27:00 AM

 Robust go/no-go (GNG) decision-making is essential for effectively managing risk across a clinical portfolio. In early phase development, it is particularly important to have the correct tools in place to terminate ineffective compounds quickly, while accelerating promising ones through the process. 

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Topics: Bayesian Methods, Case Study, go-no-go, biostatistics, Bayesian, custom software


Setting the Right Foundations: The Role of the Independent Randomization Center

Posted by Liz Cole

Mar 20, 2017 9:54:00 AM

 In the randomized clinical trial (RCT), the process of deciding the randomization method and implementing is critically important. Unfortunately, it is not unheard of for problems to arise. In an article (Downs et al 2010 1), it is noted that as well as initial errors of trial design, problems can arise from errors with programming of the randomization or even human error during the course of...

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Topics: Clinical Research Services, biostatistics, randomization


The Data Management Plan Takes Center Stage- why is it so important?

Posted by Cytel

Mar 15, 2017 8:51:00 AM

 

A precise and thorough approach to planning is key for success in data management.

The Data Management Plan (DMP) is a critical document in any data management project. It outlines all of the data management work to be done, the timelines and milestones to be achieved, as well as the outputs to be produced. The DMP lets all of the stakeholders know what to expect, how to expect it and when...

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Topics: Data Management, Clinical Research Services, outsourcing, Clinical Data, data manager


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


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


Estimands 101: Interview with Mouna Akacha

Posted by Cytel

Feb 27, 2017 7:39:00 AM

 

It’s been hard to miss the prevalence of estimand-related discussions in the last year.  This is a topic which is very much at the forefront of statistics discussions right now.  We are lucky enough to welcome Mouna Akacha to the blog to give us the lowdown on estimands and the problems and opportunities they represent for the global biopharma industry. 

Mouna is a Consultant in the...

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Topics: Regulation, clinical development, biostatistics


Syntax and Variables in R: A Primer

Posted by Cytel

Feb 21, 2017 9:39:07 AM

 

 In a previous blog, we provided an overview of basic data structures in R.  In this follow up piece, we will provide a snapshot of basic syntax in R for programmers who want to get up to speed in this increasingly important programming language. 

 

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Topics: Statistical Programming, biostatistics, SAS, R


Outsourcing success for emerging biopharma

Posted by Cytel

Feb 15, 2017 9:33:05 AM

Outsourcing solutions should never be a one size fits all process, and smaller and emerging biopharma companies may  have different priorities and processes when working with external vendors to larger pharmaceutical organizations.

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Topics: outsourcing, Clinical Data, data manager, biostatistics, Biometrics, RFP


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


The Making of a CDISC Trainer

Posted by Cytel

Feb 6, 2017 9:10:00 AM

 

CDISC is a global, nonprofit charitable organization whose mission is ‘to inform patient care and safety through higher quality medical research’.  The organization delivers this mission through the development of data standards designed to streamline clinical research- these standard formats are increasingly expected for use in data submissions by regulatory authorities. Importantly, data...

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Topics: Statistical Programming, Training and Education, Clinical Data, CDISC, SDTM, ADaM, Biometrics, CDASH


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


Data Structures in R: A Primer

Posted by Cytel

Jan 19, 2017 7:05:00 AM

 

R is on the rise in biopharma, and as we have previously discussed on the blog, it is now time for SAS programmers to get up to speedwith this popular and powerful programming language.  Indeed, one of the advantages of R is its ability to integrate with other languages like C, C++, Python and SAS. Its strong graphical capabilities allow output in PDF, JPG, PNG, and SVG formats and table...

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Topics: Statistical Programming, biostatistics, SAS, Rstats, R


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


SAS and NONMEM - a marriage made in heaven?

Posted by Cytel

Jan 5, 2017 8:45:00 AM

 

Nonlinear Mixed Effects Modeling (NONMEM) is a type of population pharmacokinetics/pharmacodynamics (popPK/PD) analysis used in Clinical Pharmacology research. The population PK approach combined with pharmacodynamics modeling, allows integrated analysis, interpretation, and prediction of the drug’s safety, efficacy, dose-concentration relationship, and dosing strategy. 

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Topics: pharmacometrics, biostatistics, SAS, pharmacology, NONMEM


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


CDISC submissions- are you up to speed?

Posted by Cytel

Dec 21, 2016 9:45:00 AM

 

December 18th 2016 was a significant date for the pharmaceutical industry and regulatory submissions. For trials which commence after this date, the FDA will no longer accept non-CDISC data submissions for new drug applications ( NDAs) , certain investigational new drug applications, abbreviated new drug applications (ANDAs)  and certain biologics license applications (BLAs).

 The FDA...

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Topics: Regulation, Clinical Data, data manager, CDISC, SDTM, CDASH


How do CDASH standards build data quality?

Posted by Cytel

Dec 20, 2016 9:21:00 AM

 

Data Standards play a crucial role in structuring and promoting long term value of clinical data.

Clinical Data Acquisitions Standards Harmonization or CDASH was developed with participation from all three ICH regions (US, Europe and Japan) with recommended data collection fields for 16 domains-> DEMOG, AE etc. It also includes  implementation guidelines, best practice recommendations, and...

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Topics: Clinical Data, data manager, CDISC, SDTM, CDASH


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


Harnessing the power of R API to extend software applications

Posted by Aniruddha Deshmukh

Dec 13, 2016 8:18:00 AM

 

In the complex world of trial design and data analysis biostatisticians and data scientists need to ensure they are selecting and harnessing the best capabilities of the powerful software tools available to them. Particularly when non-standard approaches are required, this may mean using a combination of tools to come to the most appropriate solution for any task.

At the recent EARL...

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Topics: Cytel Strategic Consulting, Rstats, R


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