At Cytel we believe that expert statistical input has the power to shape the future of clinical development: de-risking portfolios, accelerating timelines, and increasing the probability of success.

In this blog we talk to Adam who lives in North Carolina United States to find out more about his career path, achievements, current role at Cytel and his interests outside of work.

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

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

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...

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

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...

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

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...

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

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...

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

At Cytel we believe that expert statistical input has the power to shape the future of clinical development: de-risking portfolios, accelerating timelines, and increasing the probability of success.

In this blog we talk to Benjamin who lives in France, to find out more about his career path, achievements, current role at Cytel and his interests outside of work. 

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

Our strategic consulting team work on projects such as: Identifying the best clinical trial design, implementing adaptive designs, developing a regulatory strategy and interacting with regulators.

In this blog we talk to Ursula who is based in Germany, to find out more about her career path, achievements, current role at Cytel and her interests outside of work. 

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

As we prepare to close the door on 2017, we thought we would take a look back at the  topics which have been most popular on the Cytel blog this year.  It's an interesting insight on what pain points and opportunities feature highly on our global biopharma audience's radar.  Read on to learn which of our 2017 blogs have received the most interest from our audience so far.

Topics: Oncology, Data Management, Cytel Strategic Consulting, Statistical Analysis, Trial Design Software, pharmacometrics, estimands, NONMEM, data science, R language

In 2011, Cytel organized its first East User Group Meeting (EUGM) in Paris. Since then, we have held an EUGM almost every year, alternating between locations in Europe and North America.  These meetings have been a great success, giving opportunities for customers and industry colleagues to meet each other as well as with key opinion leaders, whilst learning more about our East software and...

Topics: Cytel Strategic Consulting, Clinical Development Strategy, Adaptive Clinical Trials, Statistical Innovations in Clinical Development, EAST 6.4, adaptive trials

James (Jim) Bolognese, Senior Director, Strategic Consulting, Clinical Services at Cytel Inc. was named a 2017 fellow of the American Statistical Association (ASA). Jim will be officially honored by the ASA at the Joint Statistical Meetings in Baltimore, Maryland this summer.

Topics: Cytel Strategic Consulting, Interim Analyses, Statistical Analysis, Clinical Development Strategy, Adaptive Clinical Trials, biostatistics, adaptive designs

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...

Topics: Cytel Strategic Consulting, Cytel Consulting, Statistical Programming, Phase 1, Dose-Finding, Compass, Phase I, biostatistics, adaptive designs, adaptive trials

As a group, Cytel had over 40 successful regulatory interactions last year, many of which supported approvals for innovative trial design approaches.  In this blog we look at some of the key success factors for regulatory interactions regarding adaptive designs.

Topics: Cytel Strategic Consulting, Cytel Consulting, Regulation, biostatistics, adaptive designs, adaptive trials

 

In the complex world of trial design and data analysis biostatisticians and data scientists need to ensure they are selecting and harnessing the best capabilities of the powerful software tools available to them. Particularly when non-standard approaches are required, this may mean using a combination of tools to come to the most appropriate solution for any task.

At the recent EARL...

Topics: Cytel Strategic Consulting, Rstats, R

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.

Topics: Oncology, Enrichment, Cytel Strategic Consulting, Phase 3, patient enrollment, biostatistics, adaptive trials, personalized medicine

 

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...

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

 

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...

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

 

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. ...

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

Cardiovascular outcome trials (CVOTs) have earned the reputation of being the untamable behemoths of the clinical world. Needless to say these trials are long and require extremely large sample-sizes. The Contrave LIGHT study required 8900 patients. The SAVOR TIMI trial enrolled 16,492 patients. Even the EXAMINE trial, which benefited from a promising zone design, required 650 patients. 

...

Topics: Cyrus Mehta, Promising Zone, Cytel Strategic Consulting, Interim Analyses, Program and Portfolio Optimization, Cardiovascular, Clinical Development Strategy, Adaptive Clinical Trials

We are often asked how statistical consultants can add value to the clinical development process. What do they contribute to a winning strategy, and how do they optimize business decisions? 

Statistical consultants often have decades of experience in multiple aspects of clinical development, including trial design, portfolio optimization, and regulation. Having a broad and yet nuanced feel...

Topics: Data Management, Cytel Strategic Consulting, Cytel Consulting