2020 has been an unusually difficult year as the global pandemic impacted all of our lives. This year, the Cytel blog saw a lot of activity as we tried to keep our readers abreast with the latest updates on the COVID-19 clinical trials, and covered other trending and important topics such as, the growing adoption of Synthetic Control Arms, master protocols, Head to Head Comparisons and Bayesian methods. We also collaborated with several experts from both within and outside the company to conduct several series of webinars and provided summaries through our blogs.
Continue reading to learn about the top 10 Cytel blogs that resonated most with our community in 2020.
COVID-19 Clinical Trials Guidance and Cytel’s Trial Tracker
No doubt some of the favored blogs of the year were all related to COVID-19. The COVID-19 pandemic created extraordinary circumstances that were likely to impact the ongoing clinical trials. Adjustments were necessary due to quarantine, limited access to hospitals, and the focus of healthcare professionals on critical tasks. In March 2020, the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) published guidances and new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the COVID-19 pandemic.
Cytel published reviews of selected elements of the guidance, interpretations and recommendations:
In April 2020, Cytel launched an open-access global COVID-19 Clinical Trial Tracker to help facilitate greater collaboration between researchers, policymakers, clinicians, journalists, philanthropists, and other critical stakeholders who need to understand the complex dynamics of the global response to finding a solution to the COVID-19 outbreak.
Funded in part by The Bill and Melinda Gates Foundation, a leader in global health solutions, this live dashboard offers an overview of all the trials taking place in the international effort to tackle the pandemic. Cytel published a series of blogs that provided a snapshot on the state of COVID-19 therapy and vaccines development.
New Primer and Ebook on Synthetic Control Arms
The rising costs of clinical trial completion and the greater availability of data, make the uses of synthetic control arms a less-costly option adopted in a number of clinical trials, owing to the absence of either a full or partial control group. They are generally most useful when practical or ethical reasons limit randomization to control.
Cytel published a new ebook on synthetic control arms and a scientific primer. Read the blog for an introduction to synthetic control arms and download the ebook here.
Cytel’s Career Perspectives blog series features interviews with employees where they talk about their career path, achievements, current role, opinion on industry trends and offer career advice relevant to our field.
In 2020, we interviewed some of our experts who have a long-standing association with Cytel. Read two of these interviews here:
The Good Data Submission Doctor: CDISC for COVID-19
“The Good Data Submission Doctor” is a blog series authored by Angelo Tinazzi, Senior Director, Statistical Programming, Clinical Data Standards and Clinical Data Submission at Cytel. Following the outbreak of the pandemic, CDISC launched a task force in an effort to support CDISC members and the research community as they work tirelessly to discover critical breakthroughs to treat COVID-19. On April 21, 2020, the task force released two guidances. In this issue, Angelo provides a quick summary of what these guidances address. Read more.
Ensuring an Unbiased Comparator Arm
Regulators in both the United States and Europe have responded positively to the use of Synthetic Control Arms (SCAs) in clinical development. While implementation of this method for regulatory purposes might be a new development, most statistical and mathematical theories used for the design of SCAs are decades old and familiar to the scientific community. However, as with any sophisticated statistical method, deciding on the optimal SCA approach is a necessary condition to ensure robustness of findings. Learn more.
Webinar: Key Design Considerations for Basket Trials and Umbrella Trials by Jay Park
Jay Park, Director, Cytel, presented a webinar on “Key Design Considerations for Basket Trials and Umbrella Trials”. This webinar introduced two master protocol types and explored their extension to design in various contexts from the HIV epidemic in global health to expedited oncology trials. This blog provides key highlights from the webinar. Read more.
Head to Head Comparisons Using Real World Data: An Interview with Miguel Hernan
Cytel is pioneering two “Head-to-Head Comparisons using Real World Data” studies, one in oncology and one in cardiovascular disease. These projects occur in real time across Cytel’s webinar series where our experts talk about the data and analytical challenges faced during the projects, and how these challenges are overcome. The speakers for the first webinar include Professor Miguel Hernan of Harvard University’s TH Chan School of Public Health. In this interview, Professor Hernan provides insights on the advantages and future of head to head comparisons using real world data. Read more.
Overcoming Clinical Development Challenges in Oncology with Innovative, Adaptive Designs:
Oncology trials face numerous challenges, ranging from small patient populations, to evolving endpoints, to complex data handling and analysis. In a complimentary paper, Cytel experts in statistics, data management and functional service provision describe end-to-end delivery of successful trials in oncology, and divulge critical insights about high-quality trial planning and regulatory submission. Read more.
Interview with Jay Park: The present and future of Master Protocols
As the adoption of innovative trial methods is on the rise, we speak with Jay Park, Director, Cytel, about the concept of master protocols, their importance and future growth potential. We take a closer look at their use in oncology trials where the increase in biomarker driven enrichment and stratification designs, as well as the use of companion diagnostics, ensures that master protocols are often adopted by trial investigators. Read the interview.
Bayesian Borrowing and Real World Data: The Fundamentals
As uses of real world data become more familiar for trial design and regulatory submission, sponsors might become more interested in techniques related to Bayesian borrowing. Read this blog for an overview of the potential benefits.
Sophisticated uses of this technique have been applied to COVID-19 vaccines development and complex oncology trials. A new whitepaper describes the critical uses of Bayesian methodologies employed by Cytel statisticians, in their search for effective therapies, prophylactics and vaccines. Download White Paper.
Blog Topics Suggestions for 2021:
Share your views and topics you would like to learn about through Cytel blogs in 2021. Click the button below to complete a short form and send us your comments right away.