Featured Articles
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Why You Should Construct Primary Endpoints Using Bayesian Methods: Lessons From COVID-19
7/22/2020
One of the revelations of the COVID-19 pandemic is that the flexibility and potential of Bayesian designs goes far beyond the benefits connected to informed priors. This blog summarizes a recent panel on COVID-19 drug discovery where biostatisticians and former regulators reflected on certain misconceptions about Bayesian methods.
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The Good Data Submission Doctor: CDISC For COVID-19
7/22/2020
From the time the COVID-19 outbreak was declared a pandemic, the number of studies conducted around the world to either diagnose, prevent or treat the virus literally exploded. Moreover, the pandemic impacted the regular schedule of ongoing clinical trials. This blog provides a quick summary of the CDISC guidances that address ongoing studies disrupted by COVID-19 and new COVID-19 studies.
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Three Reasons Why Oncology Trials Need Clear Estimands
7/22/2020
Unlike many therapeutic areas, oncology benefits from having standardized endpoints like overall survival and progression-free survival, as well as standardized methods of measuring such endpoints. While oncology might have the advantage of certain standard endpoints, there are still challenges that suggest estimands can clarify the research plan.
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Platform Trials, Medical Supply And Cooperation For COVID-19 Vaccines
6/15/2020
COVID-19 has brought a number of stakeholders together to seek ingenious new methods for vaccines development. Here James Orbinski, who received the Nobel Prize as the head of Medecins Sans Frontieres joins Trevor Mundel, President of the Bill and Melinda Gates Foundation, Robin Mogg of the Bill & Melinda Gates Research Institute, and Derek Angus of REMAP-CAP, one of the largest platform trials in the search for a coronavirus vaccines, to discuss new opportunities for public-private and non-profit cooperation for vaccine development.
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Trial Disruptions Due To COVID-19? Adaptive Bayesian Approaches Reveal Promising Possibilities
6/15/2020
A number of trials have been disrupted by the onslaught of the COVID-19 pandemic. A Cytel panel discussion reveals the strategic advantage of using Bayesian methods to resolve a number of trial challenges ranging from small sample sizes, flexible designs, missing data, and unpredictable recruitment. Here leading biostatisticians and former regulators discuss the opportunities these adaptive Bayesian methods offer.
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Bayesian Methodologies To Address Clinical Development Challenges For COVID-19 Drugs, Devices And Biologics
6/12/2020
There are numerous challenges when designing COVID-19 trials including include lack of prior data for candidate interventions/vaccines due to the novelty of the disease and the evolving standard of care as knowledge accumulates on the COVID-19 disease, and emerging evidence from completed trials. Bayesian statistical methods are very well suited to address these challenges due to their ability to adapt to knowledge that is gained during a trial.
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Completing Trials Disrupted By COVID-19: Strategies And Solutions From Expert Statisticians
6/12/2020
Our statisticians have advised on a number of trials confronting skewed or missing data, unexpected comorbidities, patient recruitment and retention challenges, unanticipated interim looks, updated Statistical Analysis Plans, and a range of other difficulties impeding trial completion. Here we summarize the most common questions confronting Cytel’s clients and outline strategic solutions provided by our expert statisticians.
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New Opportunities & Implications For The Future Of Drug Development In Emerging Economies
5/11/2020
Ed Mills, Cytel’s Vice President of Real World Evidence hosts a panel on how COVID-19 is affecting access to drug development and equitable medical care in emerging economies.
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Podcast: COVID-19 Trial Tracker
5/5/2020
The Cytel COVID-19 Trial Tracker is an interactive tool to help you get answers to specific questions about the state of COVID-19 studies. Organized by country, therapeutic area, and trial status, this COVID-19 Trial Tracker helps visualize the state of clinical development. Whether you want to know how long recruitment for a vaccine trial is projected to take, or the number of hydroxychloroquine and remdesivir trials globally, this Trial Tracker is designed to answer transparently. Listen to a podcast with its creator Louis Dron.
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COVID-19 Pandemic: Response To Regulatory Guidance
5/1/2020
A number of non-COVID related trials are facing disruptions due to the coronavirus pandemic. Cancelled patient visits, new comorbidities, and more resource constraints have resulted in missing data, questions about recalibrated SAPs, and concerns about maintaining statistical power. Cytel co-hosted a panel to talk through some of these challenges.