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 must be defined so that trial unblinding is not compromised and bias remains controlled.  In this blog, we will explore an innovative approach developed by members of our statistical programming team to improve the efficiency of this process, while maintaining the highest levels of data security. 

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Topics: Clinical Research Services, Statistical Programming, Interim Analyses, Blind and Unblind Trials, Clinical Data, ACES, biostatistics, DMC


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


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


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 presentation on Traceability within the Foundational standards track.

In this blog, Angelo highlights some of the hot topics which emerged from the presentations he attended during the meeting. 

 

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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 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


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


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 attention on data sources which are in the most need of oversight, while decreasing attention on sources of data that have historically proven to be reliable.

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Topics: Data Management, Clinical Data, Risk Based Monitoring


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: A specialized CRO is exactly that, specialized. It sustains itself by being extremely good at doing the thing you hired it to do, and doing it better than everyone else. Clearly you want a specialized CRO because clearly you want the best.
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The decision is difficult in part because it touches upon various crucial points of a clinical trial sponsor's strategy: top-notch knowledge and expertise, timely delivery, simple responses to unforseeable events. Your business and development strategy should ultimately affect your decision-making. 

Here are a few things you might consider to avoid making a decision that is wrong for you. 

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Topics: Data Management, Clinical Research Services, Clinical Data


Mitigate Phase 3 Clinical Trial Risk by Optimizing Phase 2 Data

Posted by Esha Senchaudhuri

Aug 10, 2015 2:32:34 PM

When approaching a Phase 3 clinical trial, the need to ‘de-risk’ the massive investment often leads sponsors on a quest for the perfect risk mitigating adaptation. While a strategically planned clinical trial design can be an important step in giving a new medicine its best possible chance of success, there are a number of other ways that a trial sponsor can minimize study risk.

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Topics: Dose-Finding, Early Phase Trials, Proof-of-Concept, Clinical Data, MCP-Mod


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