With adaptive and innovative trial designs on the rise, operational implementation of interim analyses, including management of Independent Data Monitoring Committees is increasingly important.  In this blog, we will share a case study of how Cytel provided a client with seamless Independent Data Monitoring Committee support encompassing committee selection and management, independent statistical services, and ACES software. 

By Tejasweeni Rajput

It’s been known for centuries that a picture can tell a thousand words. In an era of new technologies, and increasing volume of information, visualizations can help us to express complex data simply and effectively. Advanced technology is now available that allows statisticians and data scientists to drill down into the data sets to be analysed, and develop dynamic graphics that one can interact with. This marks a leap forward in decision-making capabilities from the static figures which have been traditionally available to us.

About the Author: Manjusha Gode has over 28 years' IT experience spanning delivery Management, quality management, software testing,  people management, process improvement and multi-locational operations.  She is a pioneering member of Cytel's clinical programming team.

 Clinical data transparency improves decisions for all healthcare stakeholders including patients, caregivers, healthcare providers, payers, and regulators.

The topic of transparency and the process by which clinical trial data can be effectively anonymized and disclosed for use by researchers has become a hot topic in recent years. In this blog, we will discuss the broader context of patient privacy and the key considerations for biopharmaceutical companies in this area.

PharmaSUG 2017 proved to be an inspirational and informative event. With over 200 paper presentations, posters, and hands-on workshops to choose from, delegates could select the topics most relevant to their statistical programming experience and interests.

PharmaSUG papers are split into 15 different academic sections, and Cytel was well represented in the Statistics and Pharmacokinetics stream with two of our talented programmers, Chris Smith and Sharmeen Reza, presenting separate papers.

We are delighted to announce that Chris Smith, Senior Statistical Programmer was awarded best paper in his stream. The winning paper Multiple Imputation: a Statistical Programming Story was co-authored with industry colleague Scott Kosten.

This new case study shares how Cytel supported a specialist biopharmaceutical company from Phase 2 trial design through to an FDA submission for their lead product candidate. We assembled an expert multidisclipinary team of data coding specialists, biostatisticians, statistical programmers and medical writers to support a number of the studies in the ongoing program, including pivotal Phase 2b and 3 trials, and the subsequent creation of the Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE). 

Statistical programmers at all levels can make a significant impact on streamlining delivery, improving efficiency, and importantly ensuring quality.  At a recent PhUSE Single Day event , Cytel's Sunil Gupta gave a very well received presentation on how best to achieve high quality deliverables while maintaining efficiency, noting that 3 key components should be observed:

 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. 

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 standardization also brings significant benefits to the industry- in the CDISC 2014 Business Case (1),  it is noted that:

 “For those developing regulatory eSubmissions, using updated baseline numbers for the time and cost of getting a drug to market, it can be found that ~ $180M can be saved per submission (18% of the total cost). An average of two years can be saved off of an average 12-year clinical development program lifecycle – just by standardizing data”.

It’s therefore critical that the biopharma and CRO industries develop the next generation of data managers, statisticians and programmers with strong knowledge of the CDISC standards.

Angelo Tinazzi has more than 20 years’ experience in data-management and statistical programming and is Director of Clinical Data Standards and Data Submission at Cytel.  He has been a member of the European CDISC Committee since 2015 and is a member of the CDISC ADaM team. Taking the next step in his journey as a data standards expert, Angelo is now a "candidate trainer" with CDISC –working towards becoming an “Authorized CDISC Instructor”.  In this blog we find out more from Angelo about his experiences and the role of the CDISC trainer.

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 into an ‘umbrella’ protocol which addresses both SAD and MAD objectives.

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 outputs for LaTeX and HTML. Importantly, as an open source resource, there is a strong community around R and extensive support for users in the form of forums like R-bloggers, StackOverflow and GitHub Repository

In this blog, we’ll provide an overview of R basic structures for programmers.  

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.  

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.

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.

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.

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 topic in the industry.

It has traditionally been common practice for biopharma companies to outsource their CDISC conversion of legacy data for the purpose of publications and submissions to expert CROs.  While large biopharma organizations may have dedicated in-house teams deployed to the management of standards governance, the dynamic nature of CDISC requirements means companies can struggle to find the resources to keep up to date and provide the best interpretation of the documentation. Outsourcing can be an option to ensure dedicated staff are available to manage and monitor these aspects and ensure companies remain submission ready.

Statistical programmers are in high demand within the biopharmaceutical industry, and within the dynamic world of clinical trials the part they play is ever evolving.  In this blog, we take a look at 5 trends which are shaping their roles in 2016 and beyond. 

Why do we do what we do?  At Cytel we have always been driven to deliver benefits in the service of human health, and ultimately to bring new drugs to the patients who need them.  In the context of our work in statistical software, we have recently had the opportunity to support an important conservation project defined by a similar passion to make a difference.  

While our core focus has always been in biostatistics, and thus in the life science industry, our StatXact statistical software is used by customers across a broad spectrum of natural and social sciences thanks to its ability to handle small sample sizes. 

The Association Takh is one such customer.  Takh is dedicated to the re-introduction of the world’s last wild horse, as well as conservation in Mongolia and improvement of the lives of Mongolian herders.  (1) In 2004 and 2005 the association reintroduced 22 Przewalski’s horses( one of the world’s most endangered species)  from Le Villaret in southern France to the buffer zone of Khar Us Nuur National Park in the Khomyn Tal herder community of western Mongolia.

At a recent PhUSE SDE, Cytel’s Chitra Tirodkar presented how East PROC MCPMod could be used  to  help solve the problem of uncertain true dose-response relationship in a bronchodilator study.  In this blog we summarize some of the issues, and make Chitra's slides available for download.