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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 regulatory references.  There is sometimes a misconception that CDASH defines the layout of the CRF and eCRF.  This is not the case.  The function of CDASH is to define the naming conventions for the clinical database, and outline how variables are mapped to SDTM. It defines how questions should be formulated for data collection within the CRF and eCRF making use of standard CDISC controlled terminology. In this blog, we will provide an example of CDASH implementation. 

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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 of adaptive design.  As a follow up to this, Munya is now Lead Investigator of the ACE project which aims to develop a consensus-driven reporting guidance tailored for Adaptive designs in the form of a CONSORT extension. The ACE Project is funded by the NIHR and is led by a multidisciplinary Steering Working Group of international experts in collaboration with the CONSORT Executive Group and the MRC HTMR Adaptive Designs Working Group.  The goal is to enhance transparency, credibility, reproducibility, and replicability of adaptive trials as well as facilitate uptake of ADs in clinical trials research when appropriate.

  We are delighted to welcome Munya Dimairo back to the blog to give us the inside scoop on this project.

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Topics: biostatistics, adaptive designs, adaptive trials


Ensuring quality data no matter the phase: data management considerations

Posted by Cytel

Dec 6, 2016 10:18:00 AM

The management of quality clinical data collection is built on a number of core essentials- including project management, timeline management, understanding of the deliverables, alignment with statistics and selection of the right technologies.  However, clinical development is a complex business and clinical data management approaches must be tailored to meet the specific needs of the trial.  In this blog, we take a look at some of the key considerations to be addressed by data management across the different clinical development phases.

 

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Topics: Clinical Data, EDC, database build, data manager


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 have previously discussed on the blog, the 10 steps proposed by Jim Bolognese and Ranganath Nayak to assist sponsors in making this decision. In this blog, we are delighted to share a simple infographic outlining the process. 

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


Case Study: Dose-response modeling informs Phase 2 ulcerative colitis study design

Posted by Cytel

Nov 18, 2016 10:04:00 AM

 

Challenge

Our client had the following key questions which they wanted our pharmacometrics group to address for an upcoming phase 2 trial of their ulcerative colitis compound .

1) Can knowledge from pre-clinical and Phase 1 data inform on the optimal range of doses for an upcoming Phase 2 dose-ranging study?

2) How may the dose response observed in PD markers in Phase 1 healthy volunteers translate to the patient population?

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Topics: Cytel Strategic Consulting, Case Study, pharmacometrics, biostatistics, PK/PD


Infographic: 9 Do's and Don'ts to Ensure Independence of QC in Statistical Programming

Posted by Cytel

Nov 14, 2016 8:13:29 AM

In our last blog, we shared some of Angelo Tinazzi and Cedric Marchand's recommendations on how to ensure independence of QC in statistical programming.  Now, we've put together an infographic highlighting some key do's and don'ts in a handy checklist.  

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Topics: Statistical Programming, biostatistics, SDTM, ADaM


How to ensure independence of QC in statistical programming 

Posted by Cytel

Nov 11, 2016 10:05:14 AM

A solid and robust QC process is one vital component of ensuring quality programming delivery. Angelo Tinazzi and Cedric Marchand presented at the PhUSE conference recently on the topic of ‘What Auditors want’. As part of this well received presentation, the duo discussed the question of independence of QC and how to make sure this is fully observed.

In this blog we’ll walk through their recommendations to ensure independence of QC in programming.

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Topics: Trial Quality, Statistical Programming, Statistical Analysis, CDM


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 strategy.

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


R Beyond Statistics

Posted by Cytel

Oct 25, 2016 7:59:00 AM

 

Use of R is a hot topic among statisticians and programmers in the pharmaceutical industry.  At the recent PhUSE conference in Barcelona there was a clear uplift in interest in the  language and a number of sessions explored introductory principles and examples of how R can be used in practice.  Cytel's Namrata Deshpande presented on the use of R beyond Statistics through a case study of the development of a user friendly tool deploying non-statistical packages in R to enable clinical decision making. The talk won first prize in the Trends and Technology track at the PhUSE conference.  In this blog, we'll discuss some of the aspects presented and share Namrata's slides for download.

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Topics: Clinical Research Services, Statistical Programming, clinical development, Rstats, R


Cytel Infographic: 6 Hot Topics from PhUSE 2016

Posted by Cytel

Oct 18, 2016 9:38:00 AM

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Topics: Statistical Programming, Clinical Data, SAS, Rstats, R


The evolving role of the modern statistical programmer

Posted by Cytel

Oct 13, 2016 9:16:00 AM

Statistical programmers play a key role in turning the data from clinical trials into knowledge and supporting the development of new medicines.  In a dynamic industry with demands such as CDISC compliance, data transparency initiatives, big data, and cost pressures the role is evolving to become ever more multi-dimensional. Statistical programmers now have the opportunity to follow their specific interests and specialize in a range of areas.

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Topics: Clinical Research Services, Statistical Programming, clinical development, SAS


Simulations to optimize clinical trial programs

Posted by Cytel

Oct 11, 2016 9:31:00 AM

Its important to take a strategic  approach to clinical development  in order to minimize the potential for Phase 3 attrition. The below infographic, previously published on the blog highlights some of the approvability and economic reasons cited for Phase 3 failure , and the clinical development issues which may have had an impact. 

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Topics: Clinical Development Strategy, Phase 3, Dose Selection, phase 2, Simulations


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 complexity in the data collection itself, so knowledgable data management support is needed to successfully execute an innovative trial design.  In this blog, we take a look at 5 top considerations for successful adaptive trial data management. 

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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 his presentation on his broad industry experience. 

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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 and operational characteristics, as well as related regulatory interactions.  

To read an abstract and details of the full publication click here. 

 In this blog we'll take a look at some of the case studies under discussion. 

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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


Practical Challenges of the LUNG-MAP study

Posted by Cytel

Sep 27, 2016 9:24:00 AM

The Lung-MAP  trial is an innovative biomarker driven 'precision medicine' study which evaluates five novel agents for the treatment of patients with advanced squamous cell carcinoma of the lung.  As well as exploring therapeutic options for this indication, it also aims to improve the drug development process. 

At a Cytel seminar earlier in the year, Antje Hoering of CRAB presented to delegates on some of the practical challenges of the Lung-MAP study.

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Topics: Oncology, Precision Medicine, Clinical Development Strategy, Phase 3, phase 2, EDC


An efficient tool for model based meta-analysis

Posted by Cytel

Sep 20, 2016 9:42:00 AM

 

Drug development is an expensive and risky business.  To maximize a compound’s ultimate chances of commercial as well as regulatory success it’s imperative that sponsors are building up a strong understanding of its characteristics relative to competitors.  This knowledge can support critical decisions along the development path, such as optimizing dosing, and selecting the best active control. Importantly, it also ensures the sponsor can build a body of evidence and quantify the benefits of the compound in the context of other treatment options.  This knowledge can streamline the path to drug approval and support the drug’s chances of commercial success when it reaches the market.

 Model based meta- analysis (MBMA) is becoming an increasingly utilized strategy to conduct this competitive benchmarking. 

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Topics: Clinical Development Strategy, pharmacometrics, clinical development, pharmacology


Case Study:Exposure Response Modeling in Hematology

Posted by Cytel

Sep 13, 2016 10:15:00 AM

 

Exposure-response data gained from clinical studies can provide a basis for model-based analysis and simulation, helping to predict the expected relationships between exposure and response.  Using this approach, it may be possible to optimize dosage regimens and to individualize treatment in specific patient subsets for which there are limited data.  In this blog, we examine a case study of an exposure response modeling project conducted by our Quantitative Pharmacology and Pharmacometrics team. 

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Topics: Cytel Strategic Consulting, Phase 3, pharmacometrics, biostatistics, pharmacology, PK/PD


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