Featured Articles
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COVID-19: Trials, Designs And Tools For Promising Results
5/1/2020
How can we harness the power of data science and trial design to achieve expedited clinical development for a new coronavirus vaccine? Experts from around the world weigh in on this panel.
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Cytel's Response: EMA Guidance On The Management Of Clinical Trials During The COVID-19 (Coronavirus) Pandemic
3/25/2020
On March 20th the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) published new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the COVID-19 pandemic. Here is a review of selected elements of the guidance, interpretations and recommendations.
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Cytel's Response: FDA Guidance On Conduct Of Clinical Trials During The COVID-19 Pandemic
3/25/2020
The FDA recently issued a guidance on how the COVID-19 Pandemic may affect the conduct of clinical trials. Here are some key messages from the guidance along with some interpretations and recommendations.
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Clinical Development Challenge - Use Of RWA To Understand Natural History
2/26/2020
A biotechnology company without an in-house real-world evidence team did not have the adequate resources, connections, or expertise available to conduct a natural history study of the rare, oncology indication for which they were developing a new therapy. Their solution was found in a virtual real-world evidence department.
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Bayesian Methods For Contending With Homogeneity And Heterogeneity In Real World Data
2/26/2020
Over the past decade, single arm trials have increasingly become an accepted way of assessing a new treatment intervention. These trials make use of synthetic control arms (SCAs) and real-world data or historical clinical trial data. Learn what situations are best suited for SCAs and how homogenous and heterogenous patient populations can impact the trial.
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Ensuring An Unbiased Comparator Arm In Clinical Development
2/26/2020
Regulators in the U.S. and Europe have issued a positive response to the use of synthetic control arms (SCAs) in clinical development. The desire for faster and less expensive clinical trials, coupled with the availability of real-world data, were prominent factors. Learn how to avoid sampling bias when using real-world data in conjunction with SCAs.
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Are You Harnessing The Power Of Your Clinical Data?
1/10/2020
In clinical development, we all strive to deliver therapies that improve patients’ lives. However, the clinical data we generate can profoundly impact our success in achieving this goal. However, generating high-quality clinical data is far from straightforward, especially if you don’t have the appropriate in-house expertise. In this eBook, we discuss what is involved in planning a clinical data strategy for the entire duration of a development program, as well as for Phase 1 and Phase 2 trials specifically. We also outline some best practices for planning your data strategy, including tips from Cytel experts working in our Strategic Consulting, Clinical Research Services and Data Management teams.
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The Good Data Submission Doctor: Should I Stay Or Should I Go?
9/11/2019
A recurring question we get from clients is whether it is worth adopting data standards such as CDISC in the early phase of their drug development, and if it is worth spending more to produce SDTM and ADaM packages at an early stage. Learn more about why this could be a good decision for your company and steps you can take towards adopting them.
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Adaptive Design And Health Economic Analysis: Interview With Laura Flight
9/11/2019
In this Q&A with Laura Flight, National Institute for Health Research (NIHR) Doctoral Fellow we take a deep dive into the objectives of her recent paper "A Review of Clinical Trials With an Adaptive Design and Health Economic Analysis" Learn more about the next steps for promoting better understanding in this area.
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Advancing Oncology Development With A Synthetic Control Arm Trial
8/7/2019
A specialized biopharmaceutical company had a breakthrough therapy that had the potential to be first-in-class for a rare and aggressive hematological cancer and had shown great potential in earlier clinical trial. In many breakthrough treatment areas, where the patient population is small, or there is overwhelming evidence of efficacy at Phase 2, it has become common for drugs to be approved based on a pivotal single arm trial – however, this is not always optimal. Read how synthetic control offers a practical, effective way to leverage real-world evidence and has been applied in regulatory approvals.