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

Podcast: Overcoming Phase 1 Development Challenges

January 10, 2019

 

Nand Kishore Rawat is a Director and Head, Early Phase Biostatistics based in the King of Prussia, PA Cytel office. We recently spoke with Nand for the Cytel podcast to gain his thoughts on the unique aspects of Phase 1 development and where innovative approaches supported by thorough planning can meet these challenges head-on.  Read on for key insights or listen to the podcast. 

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Creating a Common Language: Forging Statistical and Clinical Collaborations

December 5, 2018

 

In this blog, Paul Terrill, Director of Strategic Consulting at Cytel outlines his blueprint for ensuring smooth communication between statistical and clinical stakeholders. Paul draws upon his 20 years of experience working as a statistician and his training background to share his guidelines for success. Whether you are a statistician looking to hone your project communication skills, or a clinician keen to maximize the benefit of statistical input to your trial, this article will provide helpful pointers.

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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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Career Perspectives: Interview with Adam Hamm, Director of Biostatistics

September 20, 2018

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.

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

September 17, 2018

 

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

September 10, 2018

 

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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