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...

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


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...

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


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...

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


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...

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Topics: Clinical Research Services, biostatistics, adaptive trials, adaptive designs, psychiatry and neuroscience


Case Study:Seamless Phase 2/3 Design in Rare Disease

Posted by Cytel

Sep 9, 2016 9:24:00 AM

 

Challenge:

Our client, an emerging biotechnology company, was preparing for the next stage of development for their novel compound in a rare disease.  They had two major concerns which they wanted the clinical trial design to address- an anticipated difficulty in recruiting subjects to the trial, and  the cost and time investment associated with running separate phase 2 and phase 3 trials. ...

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Topics: biostatistics, adaptive trials, EAST 6.4, Seamless designs, phase 2, Phase 3, Clinical Research Services, Cytel Strategic Consulting


Overcoming challenges of 'Less Well Understood' Adaptive Designs

Posted by Cytel

Sep 7, 2016 8:00:00 AM

In the 2010 draft FDA ‘Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics',  the agency makes an important distinction between ‘well understood’ and ‘less well understood’ adaptive designs.

‘Well understood” adaptive designs may include such approaches as adaptation of eligibility criteria, adaptation for stopping early and adaptations to maintain study power...

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Topics: Clinical Research Services, adaptive trials, adaptive designs, type 1 error, Software Simulations, DMC, sample size re-estimation, patient enrollment


Operational and regulatory considerations in a promising zone trial

Posted by Cytel

Aug 9, 2016 9:00:00 AM

At the recent JSM Meeting, Cytel’s Yannis Jemiai presented the case study of the VALOR trial which used a promising zone design. At the time of the study, existing therapy for relapsed or refractory AML was generally unsatisfactory with no approved drugs available for patients, and a very poor prognosis.  Vosaroxin was a first-in-class anticancer quinolone derivative which had previously been...

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Topics: Clinical Research Services, Regulation, biostatistics, adaptive trials, adaptive designs, Oncology, ACES, DMC


The CRO role in Data Standards Governance

Posted by Cytel

Aug 2, 2016 10:30:00 AM

Editor's note( this blog was refreshed in April 2018)

As CDISC compliant submissions become increasingly expected, biopharmaceutical companies are considering how to approach the issue of data standards governance.  Standards governance is a lynchpin in the management of CDISC compliance and is important for promoting standards awareness within organizations. It’s also an acknowledged hot...

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Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, CDM, Statistical Programming, SDTM, ADaM, CDISC, CDASH


6 steps to timely database lock

Posted by Cytel

Jul 28, 2016 10:06:00 AM

To close a clinical database right the first time you have to begin with study start-up. Clearly, you can’t close a database if the data is not cleaned and you can’t have clean data unless you know what is most important for analysis. It’s imperative that data management works closely with the statistics group during CRF/ eCRF design to ensure data is being collected and data checks are being...

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


Key considerations in selecting an EDC system

Posted by Cytel

Jul 12, 2016 9:00:00 AM

 How do you go about selecting the best Electronic Data Capture (EDC) system for your study?  There is now a vast amount of choice in the market, and many factors to take into account before making your decision.  Different stakeholders within the business may also have different perspectives, so any decision making process needs to balance these disparate needs.  

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


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


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


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


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


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


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


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


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


Do you really need a full service CRO? An exploration of strategic options

Posted by Esha Senchaudhuri

Aug 13, 2015 9:00:00 AM

Full service or specialized? Full service or specialized?

For many looking to hire a CRO, the answer is obvious.

Obvious Answer #1: A full service CRO simplifies your life by ensuring you need only one point of contact in stressful situations or when things appear to be going wrong. Clearly you want a full service CRO because clearly you want to keep things simple.  
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Obvious Answer #2: ...
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Topics: Data Management, Clinical Research Services, Clinical Data


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