The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.

Can Statisticians Contribute to Enhance the Position of Patients in Clinical Trials?

November 12, 2018

 

In this blog, we talk with Robert Greene, Founder and President of the HungerNDThirst Foundation, about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck in Darmstadt, Germany. Robert will bring a fresh perspective to the discussion of the role statisticians can play in enhancing the position of patients in clinical trials. Patient-centricity is a key topic in modern drug development, and this session aims to encourage statisticians to question the importance of a more patient-centric approach within their field.

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Selection Bias for Treatments with Positive Phase 2 Results with Simon Kirby

October 18, 2018

 

In this blog, we talk with Simon Kirby, former Senior Director at Pfizer, about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck Darmstadt, in Germany. Simon will address the topic of Selection Bias for Treatments with Positive Phase 2 Results and in this blog he explains why this is a key topic of particular relevance for pharmaceutical companies in today’s climate of accelerated development. He also talks with us about his career in statistics, current research, and his book Quantitative Decisions in Drug Development.

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Interview with Stephen Senn: 70 Years and Still Here: The Randomized Clinical Trial and its Critics

October 5, 2018

 

We are delighted that Stephen Senn will be joining us at the EUGM on November 14th and 15th in Darmstadt, Germany. In this blog, we sit down for a discussion with Stephen about his career in statistics, his advice for early career statisticians, his upcoming research, and the topic of his presentation at the East User Group Meeting “70 Years Old and Still Here: the Randomized Clinical Trial and its Critics”.

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Setting the Right Foundations: The Role of the Independent Randomization Center

March 20, 2017

 In the randomized clinical trial (RCT), the process of deciding the randomization method and implementing is critically important. Unfortunately, it is not unheard of for problems to arise. In an article (Downs et al 2010 1), it is noted that as well as initial errors of trial design, problems can arise from errors with programming of the randomization or even human error during the course of the trial. Maintaining the rigor of the RCT relies on robust and reliable randomization with no errors. If treatment allocation is inadequately concealed then overestimation of treatment effect can occur, and the ‘randomized’ control trial becomes effectively ‘non-randomized’ – putting the entire study at risk (2).

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