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


Addressing Critical Unmet Oncology Needs in the Era of Precision Medicine

Posted by Cytel

May 23, 2018 12:21:00 PM

 

 

Our Industry Voices series showcases our clients’ innovative work and breakthrough therapeutics in oncologic indications and other critical areas of medical unmet need.

In this article, we sit down with Charles Theuer, M.D., CEO of TRACON Pharmaceuticals to discuss
his work, his views on the key advancements in oncology development, the unmet needs yet to be overcome, and the importance of efficient trial design in rare cancers. Click here to download a .pdf of the article, or read on. 

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Topics: Oncology, Phase 1, Clinical Development Strategy, Phase 3, Adaptive Clinical Trials, biostatistics


Rewriting the oncology textbook with cell-based immunotherapies

Posted by Cytel

May 16, 2018 11:00:00 AM

 

Our Industry Voices series showcases our clients’ innovative work and breakthrough therapeutics in oncologic indications and other critical areas of medical unmet need.

In this article, we are delighted to share an interview with Kurt Gunter, M.D., Chief Medical Officer of Cell Medica in which he discusses his work, his views on the key advancements in oncology development, the unmet needs yet to be overcome, and the importance of strategic biostatistics input to his organization. Read on, or click here to download a copy of the article to read offline.

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Topics: Oncology, Phase 1, Clinical Development Strategy, Phase 3, Adaptive Clinical Trials, biostatistics


Innovative Oncology Trial Designs in Practice

Posted by Cytel

May 9, 2018 10:22:00 AM

As we prepare to head to ASCO in under a month's time, we are pleased to share a new ebook that showcases some key applications of innovative trial designs in the oncology development space.

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Topics: Oncology, Phase 1, Clinical Development Strategy, Phase 3, Adaptive Clinical Trials, biostatistics


Slides: East User Group Meeting and Trial Design Symposium

Posted by Cytel

Dec 4, 2017 11:28:00 AM


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 providing critical feedback. 

This year, the EUGM was held in Cambridge MA on the 25th and 26th of October. In this blog we are delighted to share the slides from some of the speakers' presentations. 

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


Interview: Clinical Trial Optimization with R

Posted by Cytel

Nov 28, 2017 10:27:00 AM

 

In this blog we turn to some reading matter, and interview Gautier Paux and Alex Dmitrienko about the recent book 'Clinical Trial Optimization with R'.  The book explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. To learn more, read on for Paux and Dmitrienko's insights.

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Topics: Cytel Consulting, Clinical Development Strategy, Software Simulations


The Cytel Story: In the Co-Founders' Own Words

Posted by Cytel

Nov 9, 2017 11:43:00 AM

 In this blog we are excited to unveil a new project which we have been hard at work on over the last few months. 

2017 marks a very special milestone for Cytel – our 30th anniversary.  Cyrus Mehta and Nitin Patel founded Cytel in 1987 with an initial objective to solve a specific problem in computational statistics.

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Topics: Cytel Consulting, Clinical Development Strategy, biostatistics


Asking the Right Questions of Your Data: Experiences in Model Informed Drug Development

Posted by Cytel

Nov 6, 2017 5:28:43 AM

 At the Chief Medical Officer Summit earlier this year, Cytel's Director of Quantitative Pharmacology and Pharmacometrics Cecilia Fosser, and Senior Director, Business Development, Chuck Gelb presented on how model-informed drug development (MIDD) techniques can improve decision-making and Probability of Success ( PoS) of clinical trial programs.  In this blog, we share some highlights and the informative10-minute video replay of their talk which includes a modeling and simulation case study. 

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Topics: Clinical Development Strategy, pharmacometrics, biostatistics, model-informed-drug-development


Career Perspectives: Interview with Namrata Deshpande, Senior Team Lead

Posted by Cytel

Sep 29, 2017 3:01:00 PM

Namrata Deshpande, Senior Team Lead will be participating in a round table discussion at the Women in Statistics event in California, October 19-21.

This is the first blog in a new 'Career Perspectives' series and we talk to Namrata to find out more on her career path, achievements, current role at Cytel and her interests outside of work. 

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Topics: East, Clinical Research Services, Statistical Programming, Statistical Analysis, Clinical Development Strategy, Statistical Innovations in Clinical Development, biostatistics, R programming, careers


How can Novel Statistical Methods Tackle Antibiotic Resistance? Interview with Scott Evans

Posted by Cytel

Sep 13, 2017 9:00:00 AM

Antibiotic resistance is one of the greatest challenges facing human health today. We are excited to welcome Dr. Scott Evans of the Harvard T.H Chan School of Public Health (HSPH) to the blog to discuss how the novel statistical methods he is developing could help tackle this global crisis.

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Topics: Clinical Research Services, Clinical Development Strategy, Statistical Innovations in Clinical Development, biostatistics, Antibiotic resistance


Design Concept for Basket Trials: Interview with Bob Beckman

Posted by Cytel

Sep 11, 2017 11:25:00 AM

At the East User Group meeting (EUGM) on 25th and 26th October, we will welcome a number of renowned industry speakers to discuss some of the most promising approaches in innovative trial design. Over the next few weeks, we will profile a number of the speakers and their talks. In this blog, we talk with Bob Beckman M.D in advance of his presentation ‘Design Concept for a Confirmatory Basket Trial'. This, the first part of a two-part interview will reveal Bob’s insights into basket trials and their potential. The second part of the blog will delve more deeply into the design concept itself and will be published after the East User Group Meeting. To learn more, read on.

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Topics: Oncology, East, Clinical Research Services, Clinical Development Strategy, Statistical Innovations in Clinical Development, biostatistics, basket trials


Are Adaptive Designs the Answer to Oncology Development Success?

Posted by Cytel

Jul 26, 2017 10:05:39 AM

Sadly, clinical development of anti-cancer therapeutics faces particularly high rates of failure, even in the context of low success in drug development as a whole. Operating costs for oncology trials are also higher than those observed across the spectrum of clinical development.  In a recent article produced for the Pink Sheet ( a leading provider of  insights and analysis for biopharma leaders)  Cytel's Yannis Jemiai explored the key challenges facing oncology development today, and discussed how adaptive designs can help to improve researchers' probability of success. The article tackles the application of adaptive designs in both exploratory and confirmatory development and the potential benefits to stakeholders, including patients. 

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Topics: Oncology, Phase 1, Clinical Development Strategy, Phase 3, Adaptive Clinical Trials, biostatistics


Don’t miss these 5 session picks at JSM

Posted by Cytel

Jul 25, 2017 7:37:09 AM

The Joint Statistical Meetings (JSM) is the largest and arguably most highly respected gathering of statisticians in the world.  It will bring together over 6000 statisticians and runs from Saturday, July 29, to Thursday, August 3, 2017. With over 600 sessions,  it can be a challenge to identify the most crucial ones to attend. To help out, we've asked some of the Cytel team for their top picks this year. 

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Topics: Oncology, Clinical Research Services, Statistical Programming, Statistical Analysis, Clinical Development Strategy, Adaptive Clinical Trials, Statistical Innovations in Clinical Development, biostatistics


Cytel ASCO 2017 Report

Posted by Cytel

Jun 20, 2017 7:17:47 AM

 At ASCO 2017, Cytel trial design experts joined our medical and academic colleagues to share the most recent innovations in cancer research.
In this blog we will share the abstract and pdf of the poster presentation: TAPPAS: Adaptive enrichment phase 3 trial of TRC105 and pazopanib versus pazopanib alone in patients with advanced angiosarcoma (AAS), co-authored by Cytel's Cyrus Mehta and Lingyun Liu with TRACON Pharmaceuticals.  

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Topics: Oncology, Clinical Research Services, Phase 1, Clinical Development Strategy, Phase 3, Adaptive Clinical Trials, biostatistics


Measuring Intergroup Agreement and Disagreement

Posted by Cytel

Jun 8, 2017 9:50:07 AM

 

Cytel's Madhusmita Panda presented at this year’s PSI Conference in the Innovative Methodology session on the topic of ‘Measuring Intergroup Agreement and Disagreement’.

In this blog, we share the context, abstract and slides from Panda’s presentation. 

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Topics: Trial Design, Interim Analyses, Statistical Analysis, Clinical Development Strategy, biostatistics


Jim Bolognese named 2017 American Statistical Association Fellow

Posted by Cytel

May 22, 2017 9:00:00 AM

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.

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


FDA 22 Case Studies and Mitigating Phase 3 Risks

Posted by Cytel

Apr 11, 2017 10:29:00 AM

In a January 2017 paper (1), the FDA reviewed 22 case studies where promising Phase 2 trials did not result in efficacy, safety or both being confirmed in a Phase 3 trial.

At the outset, the authors of the paper are careful to state that the aim is not to assess why these unexpected results occurred, but rather to demonstrate how different trials contribute to developing our scientific understanding of the product.

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Topics: Clinical Development Strategy, Phase 3, Adaptive Clinical Trials, adaptive sample size re-estimation, biostatistics, adaptive designs


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 have previously discussed on the blog, the 10 steps proposed by Jim Bolognese and Ranganath Nayak to assist sponsors in making this decision. In this blog, we are delighted to share a simple infographic outlining the process. 

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


Simulations to optimize clinical trial programs

Posted by Cytel

Oct 11, 2016 9:31:00 AM

Its important to take a strategic  approach to clinical development  in order to minimize the potential for Phase 3 attrition. The below infographic, previously published on the blog highlights some of the approvability and economic reasons cited for Phase 3 failure , and the clinical development issues which may have had an impact. 

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Topics: Clinical Development Strategy, Phase 3, Dose Selection, phase 2, Simulations


Adaptive Designs: A Data Management Perspective

Posted by Cytel

Oct 7, 2016 8:29:00 AM


Adaptive designs have the potential to accelerate clinical development, and improve the probability of trial success. While the principle is simple- to reduce the uncertainty in clinical development by obtaining additional information from the ongoing trial- the statistical methodologies can be complex, and expert support is often required to conduct the clinical trial design. There's also complexity in the data collection itself, so knowledgable data management support is needed to successfully execute an innovative trial design.  In this blog, we take a look at 5 top considerations for successful adaptive trial data management. 

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Topics: Data Management, Clinical Development Strategy, Clinical Data, Adaptive Clinical Trials, EDC, data manager, adaptive designs, adaptive trials


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