Novel immunotherapies lean on old methods (or how to teach your dragon old tricks)

Posted by Natasa Rajicic

Sep 17, 2018 5:25:00 AM

 

Immunotherapy has brought us many promises, most notably, of a future where humans are able to harness their body’s own ability to protect them from illness. Immuno-oncology (IO) may be the ultimate frontier of that future reality, with a promise of being able to help our bodies deflect or cure us of any malignancies. Today, these therapies include cell therapies, cancer vaccine, and T-cell–stimulating antibodies, with the field continuously expanding.

While medical science behind immune-oncology (IO) treatments is fascinating and expanding at a rapid pace, so too are the statistical challenges posed by the development of these agents.

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Topics: Oncology, biostatistics, immunotherapy


Could data science be about to revolutionize the regulatory approval of new drugs?

Posted by Cytel

Sep 10, 2018 6:52:00 AM

 

The biopharmaceutical and healthcare industries now collect more data than ever before due to advances in the variety of information sources combined with the ability to store vast quantities of diverse data. Sophisticated machine learning (ML) and artificial intelligence (AI) techniques allow us to access
and analyze any combination of a multitude of data sources. The way that traditional controlled sources are viewed is being adapted in light of new evidence that emerges from real-world data. A recent Deloitte survey (1) found that 90 percent of biopharma companies are making significant investments in
real-world evidence capabilities to drive drug development and meet regulatory requirements.

Real-world evidence (RWE) has historically been used for post-marketing endorsement and in pricing and reimbursement negotiations. But could data science offer an opportunity to fundamentally shift this
paradigm, leading to better and more affordable medications being approved on the basis of RWE?

In June 2018, Cytel created and ran a survey asking respondents from our audience about the potential of data science approaches in the sector.  We are now excited to share the insights from the survey* ( designed as a qualitative pulse check) which reveal a powerful potential shift in the current drug development and approval paradigm.  

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Topics: biostatistics, real world evidence, data science


Opportunities of FDA’s Complex Innovative Trial Design Pilot Meeting Program

Posted by Cytel

Sep 7, 2018 9:55:00 AM

 

On August 29th 2018, the FDA announced (1) that it would be establishing a Complex Innovative Trial Design (CID) Pilot Meeting Program. This follows the release earlier in August of a draft guidance (2) to help advance effective and innovative clinical trial designs early in drug development that can expedite new cancer therapies.

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Topics: Oncology, FDA, adaptive sample size re-estimation, biostatistics, adaptive trials, Seamless designs


Podcast: Enhancing Patient Enrollment Forecasting with EnForeSys 2.0

Posted by Cytel

Sep 5, 2018 8:50:00 AM

 

EnForeSys is Cytel’s tool for patient recruitment planning. We have discussed on the blog recently with Tufts University's Center for the Study of Drug Development, Ken Getz, the problem the industry continues to face with patient recruitment, and the fact that most trials significantly exceed their original planned duration. In the face of this problem there's a pressing need to create more realistic plans and scenarios. To achieve this, EnForeSys models the enrollment process and then assigns probabilities for various scenarios.

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Topics: patient enrollment, enforesys, clinical trials


Highlights from the JSM 2018 Conference

Posted by Cytel

Aug 31, 2018 11:32:00 AM

 

JSM 2018, ASA’s annual gathering of over 6500 attendees attracted statisticians and data scientists to the beautiful city of Vancouver on July 28 – August 2. The conference offers a one of a kind opportunity for statisticians to exchange ideas and explore opportunities for collaboration. In this blog, we will provide access to our team's slide decks from the event, as well as some of their key takeaways from sessions that they attended.

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Topics: biostatistics, adaptive designs, Bayesian, careers, data science


Career Perspectives: Interview with Meredith Alm, Manager, QA Compliance

Posted by Cytel

Aug 23, 2018 9:11:00 AM

Cytel has grown significantly over the last 30 years, with operations across North America, Europe, and India. All of our processes, talent, and expertise are applied to maximizing the value of clinical data. At Cytel, quality comes first, and our QA team are committed to ensuring processes are in place to support our services.

In this blog we talk to Meredith who lives in Somerville, Massachusetts, to find out more about her career path, current role at Cytel, and her interests outside of work.

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Topics: Recruitment, Trial Quality, Cytel Strategic Consulting, Regulation, Statistical Programming, Statistical Analysis, Adaptive Clinical Trials, biostatistics, adaptive designs, careers, clinical trials, CRO, clinical research


How Does a CRO Programming Career Stack Up?

Posted by Nassim Sleiman

Aug 21, 2018 8:18:00 AM

 After having spent 15 years in the pharmaceutical industry, in May of 2018, I decided to explore new horizons and took the lead of the newly created Basel statistical programming team at Cytel. Building a new team in an exciting environment and being part of a successful story was the challenge I was looking for. In this blog, I will share my perspectives on what a sponsor programmer might expect when moving into a CRO role, and some of the differences and similarities of working within the two environments.

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Topics: Statistical Programming, careers, clinical research


2018 East User Group Meeting Addresses Multiplicity Themes, with keynotes including Stephen Senn and Meinhard Keiser.

Posted by Cytel

Aug 15, 2018 6:08:00 AM

 

Cytel’s 7th East User Group Meeting (EUGM) will take place on November 14 & 15, 2018 at Merck in Darmstadt, Germany, bringing together industry experts, thought leaders and applied statisticians to discuss the future of clinical trials.

The agenda has been developed collaboratively by the EUGM Scientific Committee, and keynote speakers will include Stephen Senn, Meinhard Kieser, Thomas Burnett, Robert Greene and Simon Kirby.

In this blog, we took the opportunity to talk to one of the speakers, Thomas Burnett, Senior Research Associate in Medical and Pharmaceutical Statistics at Lancaster University, about his presentation topic “Bayesian Optimization of Enrichment Designs” and his perspectives on what EUGM delegates will be able to take away from his talk.

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Topics: East, Bayesian Methods, Trial Design, Program and Portfolio Optimization, Adaptive Clinical Trials, phase 2, Simulations, adaptive designs


How can a strategic pharmacometrics consultant add value to your team?

Posted by Cecilia Fosser

Aug 8, 2018 9:45:00 AM

We have written on the blog in the past about the value that a statistical consultant can bring to your team, and to the overall clinical development process. Statistical consultants can be instrumental to the success of your development program, providing a variety of input from creating innovative trial designs that improve information quality and efficiency, to supporting regulatory interactions.

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Topics: Cytel Strategic Consulting, pharmacometrics, model-informed-drug-development, quantitative decision-making


Building interactive web applications using R Shiny

Posted by Gordhan Bagri

Aug 1, 2018 5:34:00 AM

By Gordhan Bagri and Munshi Imran Hossain with  H A S Shri Kishore

Shiny (from RStudio) is one of the most popular R packages. The package allows programmers to create applications with interactive user interfaces. These applications can then be deployed for non-programmers to perform analysis. Non-programmers can, therefore, make use of the statistical capabilities of R by means of point and click. This is one of the reasons why its use has been on the rise in the last few years.

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Topics: Cytel Strategic Consulting, Statistical Analysis, R programming, data science, R language


Infographic: 5 Key Interactions of Data Management and Statistics

Posted by Cytel

Jul 27, 2018 7:53:00 AM

In this blog, we share a new infographic based on this popular blog post illustrating some of the critical interactions that need to take place between data management and statistics groups to help ensure efficiency and data quality. 

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Topics: Data Management, Clinical Research Services, Statistical Analysis, Clinical Data, EDC, database build, data manager, big data, clinical trials


Career Perspectives: Interview with Sam Hsiao, Associate Director, Strategic Consulting

Posted by Cytel

Jul 24, 2018 6:29:00 AM

At Cytel our strategic consulting team works on a wide range of projects including: Identifying the best clinical trial design, implementing adaptive designs, developing a regulatory strategy and interacting with regulators.

In this blog we talk to Sam who lives in the Boston area, to find out more about his career path, current role at Cytel, industry experience and his interests outside of work.

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Topics: Recruitment, Cytel Strategic Consulting, Statistical Programming, Statistical Analysis, Adaptive Clinical Trials, biostatistics, adaptive designs, careers, clinical trials, CRO, clinical research


Recent Publication: On shapes of ADR report accumulation data

Posted by Cytel

Jul 18, 2018 4:40:00 AM

A recent article published by Cytel authors Samadhan Ghubade, Sharayu Paranjpe, Kushagra Gupta, Anil Gore and colleague Krishna Asvalayan in the journal Current Science, tackles the topic of adverse drug reactions (ADRs) – a matter of great concern in drug research. The authors focused their research on drugs which had been either banned or withdrawn due to a serious problem of ADRs and applied quantitative modeling techniques to see if a systematic pattern of safety signals could be detected within the ADR count data. In this blog, the publication’s authors share their thoughts on the goals, takeaways and next steps for the research and we also link to the full article.

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Topics: Cytel Strategic Consulting, Statistical Analysis, data science, pharmacovigilance, signal detection


Case Study:Creating an Effective Functional Services Partnership

Posted by Cytel

Jul 16, 2018 2:49:00 AM

In this blog we share a case study of how we established and ramped up a functional service outsourcing partnership for biostatistics, programming and data management.

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Topics: Statistical Programming, outsourcing, SAS


Unveiling New East 6.5 Modules: Join Our Webinar

Posted by Cytel

Jul 3, 2018 4:15:47 AM

 

 It’s shaping up to be a busy year for Cytel’s software development team with a number of upgrades and planned launches across our range of tools. (Watch this space for announcements soon on new quantitative decision-making software OK GO and an upgrade to EnForeSys). East, our industry leading platform for clinical trial design, simulation, and monitoring will be unveiling version 6.5 in the Fall, and delegates at the PSI conference in early June had the chance to grab a sneak peek of the new functionality in one to one demos.

We’ll also be opening the hood on the new design capabilities you can expect in East 6.5 at a complimentary webinar on Wednesday July 18, 11:00AM - 12:00 US EDT (16:00 UK, 17:00 EU).

Our presenters Pantelis Vlachos and Charles Liu, will introduce the 3 new available modules and share their insights on the supporting methodologies and their practical applications. New developments in the East software are typically derived from two sources: our team’s interaction with our customers, particularly during East training; and from our consulting practice when we help clients design their trials.

The new modules in East 6.5 include:
MCPMod (design with Multiple Comparisons Procedures)

MCPMod allows you to measure the likelihood that particular dose-response curves are the right mathematical model for a given set of data. East MCPMod will allow designing a trial using optimal allocation and then analyze the trial data using various dose/model selection criteria resulting
into a solid base (target dose) for the next phase confirmatory trial.

Population Enrichment (Adaptive designs)

An adaptive enrichment design allows the full population is segmented during interim analyses. Recently, we worked with TRACON Pharmaceuticals to design their TAPPAS trial that incorporated a population enrichment component to help overcome the potential heterogeneity of treatment effect between subpopulations for an angiosarcoma design.

Program-Level Design
It is important to take a strategic approach to clinical development to minimize the potential for Phase 3 attrition. This new module will help users apply simulations to optimize their clinical trial programs.
Click the button below to secure your place at the webinar. 

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Topics: East, Trial Design, Program and Portfolio Optimization, Adaptive Clinical Trials, phase 2, Simulations


Highlights from the PSI 2018 Conference

Posted by Cytel

Jul 2, 2018 10:00:00 AM

A number of the Cytel team were in Amsterdam, 3rd- 6th June 2018 for the PSI Conference. This year’s conference was held at the magnificent Beurs Van Berlage, a venue full of history and interesting architectural features. We took the opportunity to give delegates a first look at OK GO, our new clinical trial Go/No-Go decision-making software in this magnificent setting.

In this blog, we'll summarize some of the particular highlights from the sessions that our team members attended.

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Topics: Clinical Data, Adaptive Clinical Trials, biostatistics, adaptive designs, Bayesian, PSI Conference, estimands, data science


Measuring lots of little details: Non-Compartmental Analysis and the Early Phase Regulatory Environment.

Posted by Cytel

Jun 28, 2018 6:53:00 AM

 

By Esha Senchaudhuri

With thanks also to Jitendarreddy Seelam and Ramanatha Saralaya for their input.

The fact of the matter is that I now want to recall everything, every trifle, every little detail. I still want to collect my thoughts and - I can't, and now there are these little details, these little details...”
― Fyodor Dostoyevsky, The Meek One

Old Fyodor was hardly talking about clinical trials, but early phase trial sponsors can probably relate to a regulatory environment which requires systematic attention to details, the little details and all these little details. When conducting early phase studies, global regulators require submission of Non -Compartmental Analyses (NCAs) that measure factors such as extent and rate of exposure to a drug, without the complexity of strenuous assumptions or complex models. Through the use of rudimentary methods such as linear trapezoidal rules, NCAs make it relatively easy to measure the concentration of a drug in a body over time. They can capture length of exposure, and time of peak exposure, without the challenges of models that require independent validation [1]. While those other models are also becoming more common in quantitative pharmacometrics, ideally NCAs can complement these other methods.


It may be tempting to assume that due to the ease of measurement, it is unnecessary to invest in statistical expertise and reliable software for NCAs. While the calculations may not be as complex as other forms of pharmacometric modeling, taking shortcuts at this stage can prove problematic later on. 
Widely recognized for being ‘assumption-free’ [1] NCAs are a common subject of regulatory inquiries. Exposure and absorption data is obviously important for early phase trials, so NCAs are required for submission throughout the process. A strong data management system with reliable software can ensure that findings collected at this stage are streamlined across several early phase trials, making such information easy to access and ensuring a rapid response for regulators. Further, NCAs are often required to be submitted with early protocols making it useful to have statistical designers familiar with the NCA findings. As NCAs are an integral part of establishing an early phase audit trail, it is important to use NCA software that streamlines a detailed and complex workflow such as Phoenix WinNonlin. 


Accurate NCAs can combine with other forms of quantitative pharmacometric models like PK/PD analysis to build strong dose-response models for Phase 2. It is common knowledge that unreliable dose-response models in Phase 2 can create headaches for Phase 3 tests. Only 13.2% of Phase 3 trials that are accepted after initial rejection, are rejected on grounds of efficacy. More common reasons are dose selection, choice of endpoints, and other challenges that better Phase 2 modeling can prevent [2]. Working with statistical experts as early as Phase 1 can ensure that knowledge gleaned from NCAs can be employed to build stronger Phase 2 models, thus avoiding Phase 3 pitfalls.


Cytel has a dedicated team that has developed efficiencies and experience in early phase trials, including Non-Compartmental analyses. To learn more about our capabilities in this area, please click on the button below.

NCA
[1] Gabrielsson, J. and Weiner, D., 2012. Non-compartmental analysis. In Computational toxicology (pp. 377-389). Humana Press, Totowa, NJ.
[2] Sacks, L.V., Shamsuddin, H.H., Yasinskaya, Y.I., Bouri, K., Lanthier, M.L. and Sherman, R.E., 2014. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012. Jama, 311(4), pp.378-384.

 

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Topics: Early Phase Trials, Clinical Development Strategy, pharmacology, clinical trials


The Importance of Standardization in Clinical Outsourcing

Posted by Cytel

Jun 19, 2018 9:30:00 AM

 

At the recent PCMG conference in Malta, Adrian Otte ( Independent Consultant, formerly VP Global Development Operations at Amgen) presented to delegates the strategic choices open to sponsors when  choosing an outsourcing model and the three fundamental issues in play: standardization, flexibility and cost. In Dr. Otte's view, standardization of systems and processes is key, but is often overlooked as a factor by companies of all sizes when deciding how to outsource clinical trial activities. In this blog, Dr Otte joins us to share his insights on this topic, as well as this views on how outsourcing has evolved in recent years, and the future trends that will have most impact. 

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Topics: Clinical Research Services, outsourcing, Clinical Development Strategy, clinical trials


What makes a good data manager?

Posted by Cytel

Jun 14, 2018 10:30:00 AM

In this blog, Paul Fardy, Executive Director of Data Management at Cytel shares his thoughts on how the data manager role has evolved. 

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Topics: big data, Biometrics, real world evidence, clinical data management, clinical trials


Career Perspectives: Interview with Andrea Hita, Biomedical Data Scientist

Posted by Cytel

Jun 7, 2018 8:39:00 AM

Cytel data scientists apply advanced statistical techniques including predictive modelling of biological processes and drug interactions to unlock the potential of big data.

In this blog from our Career Perspectives series, we talk to Andrea Hita, at Data Scientist at Cytel, to find out more about her career path, her current role at Cytel and her interests outside of work.

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Topics: Recruitment, Trial Design, adaptive designs, careers, model-informed-drug-development, clinical trials, data science, CRO, clinical research, R language, genetic algorithm


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