FEATURED ARTICLES

• Why You Should Construct Primary Endpoints Using Bayesian Methods: Lessons From COVID-19

  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.

• The Good Data Submission Doctor: CDISC For COVID-19

  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.

• Three Reasons Why Oncology Trials Need Clear Estimands

  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.

• Platform Trials, Medical Supply And Cooperation For COVID-19 Vaccines

  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.

• Trial Disruptions Due To COVID-19? Adaptive Bayesian Approaches Reveal Promising Possibilities

  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.

• Bayesian Methodologies To Address Clinical Development Challenges For COVID-19 Drugs, Devices And Biologics

  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.

• Completing Trials Disrupted By COVID-19: Strategies And Solutions From Expert Statisticians

  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.

• New Opportunities & Implications For The Future Of Drug Development In Emerging Economies

  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.

• Podcast: COVID-19 Trial Tracker

  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.

• COVID-19 Pandemic: Response To Regulatory Guidance

  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.

• COVID-19: Trials, Designs And Tools For Promising Results

  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.

• Cytel's Response: EMA Guidance On The Management Of Clinical Trials During The COVID-19 (Coronavirus) Pandemic

  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.

• Cytel's Response: FDA Guidance On Conduct Of Clinical Trials During The COVID-19 Pandemic

  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.

• Clinical Development Challenge - Use Of RWA To Understand Natural History

  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.

• Bayesian Methods For Contending With Homogeneity And Heterogeneity In Real World Data

  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.

• Ensuring An Unbiased Comparator Arm In Clinical Development

  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.

• Are You Harnessing The Power Of Your Clinical Data?

  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.

• The Good Data Submission Doctor: Should I Stay Or Should I Go?

  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.

• Adaptive Design And Health Economic Analysis: Interview With Laura Flight

  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.

• Advancing Oncology Development With A Synthetic Control Arm Trial

  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.