The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
COVID-19 Response: New Opportunities & Implications for the Future of Drug Development in Emerging Economies – Q&A with James Orbinski on Global Health Policy
On May 7, Cytel and Certara conducted a virtual panel discussion on new opportunities and implications for the future of drug development in emerging economies. The speakers included highly acclaimed key opinion leaders and industry experts who spoke about new sources of research funding being channeled towards emerging economies and the need to understand its strategic priorities to properly assess future opportunities for growth.
Our first panelist, James Orbinski is a professor at York University's Dahdaleh Institute for Global Health Research. James is an experienced medical doctor, a humanitarian practitioner, a best-selling author and a leading scholar in global health. After extensive field experience with Médecins Sans Frontières / Doctors Without Borders (MSF), Dr. Orbinski was elected MSF’s international president from 1998 to 2001. He launched its Access to Essential Medicines Campaign in 1999, and in that same year accepted the Nobel Peace Prize awarded to MSF. Our moderator from Cytel, Principal Scientist, Edward Mills began the virtual panel discussion by asking James a series of pertinent questions on the issues around the current pandemic. Continue reading this post for the Q&A.
Get access to the virtual panel replay by clicking on the button below.
This has been an exciting week for COVID-19 studies. We learned that several Cytel clients who have designed new clinical trials using our East software, are about to begin enrolling. Our subject-matter experts are also heavily involved in designing vaccine trials, as well as offering biometrical support and data management for three vaccine trials that have already begun to enroll.
In our previous blog, “Remote Working Arrangement – How to get it right?”, we talked about how the need for social distancing has led most of the employers, across the globe, to make work-from-home arrangements for their employees. As we continue to stay indoors and combat COVID-19, keeping aside some time every day to read and watch useful resources on important industry topics can be very helpful. Cytel's team of oncology trial design and advanced analytics experts have been hosting a series of complimentary webinars covering a range of innovative topics including adaptive design, machine learning, estimands and trial design software. In this post, we offer you a recap of the webinars we conducted in the past few weeks. You can register for the upcoming webinars in our oncology series by clicking on the button below.
There are now over 950 trials registered, which means that 250 new trials were registered in the past week.
Only 540 of these are currently recruiting patients. This would suggest that a number of trials are failing to reach recruitment targets. The most successful trials, though, appear to suggest otherwise. They are recruiting at an unprecedented rate.
An extraordinary amount of global research is underway as the COVID-19 pandemic continues to evolve and spread throughout the world. There are over 800 registered global clinical trials taking place to develop life-saving treatments and vaccines for patients. The World Health Organization is also facilitating collaboration and accelerated efforts on an unprecedented scale. In these difficult times, sponsors must utilize innovative tools and approaches to design their clinical trials in order to provide promising results for all patient populations as quickly and efficiently as possible.
A successful virtual panel discussion was conducted by Cytel on the ongoing COVID-19 Trials, on April 15. For the second complimentary virtual panel discussion held on April 23, Cytel partnered with Certara, to present, “COVID-19: Trials, Designs and Tools for Promising Results”. It began with challenges faced by clinicians and drug developers, followed by examples of tools and trial designs currently being used to help sponsors of COVID-19 trials. Continue reading for a summary of the panel discussion.
Get free access to COVID-19 Panel slides and recording.
There are currently 665 trials registered at Cytel’s COVID-19 Trial Tracker, a jump of over 100 trials in the past two weeks. Over 20% of these trials are for chloroquine and hydroxychloroquine, while only 10 of 17 vaccine trials are currently recruiting. Are we collectively prioritizing the correct investigational studies?
Cytel's Weekly Insights takes a closer look into what the data is now telling us. We also examine projected recruitment and completion dates for vaccine trials using two new functionalities: the Cumulative Registration function shows the total number of trials that are ongoing, when they began and when they are projected to end. The Cumulative Recruitment function shows expected enrollment by treatment.
Taken together we get a clearer picture of the journey so far and insight into the complexity of a path toward a vaccine and a cure.
Every Week Cytel Brings You Further Insights from the COVID-19 Trial Tracker
From April 8 through April 17, the number of clinical trials testing COVID-19 therapies has risen to 590 world-wide. An estimated 354,000 people will need to be recruited to test these treatments properly, representing a substantial proportion of all patients diagnosed with COVID-19. Last week we looked at recruitment for chloroquine and hydroxychloroquine. This week we take a look at studies for lopinavir, remdesivir, and plasma based therapy.
Last week Cytel launched a COVID-19 Trial Tracker, an Open Access tool to track the global response to the coronavirus pandemic. This central repository of clinical trials will be updated daily to ensure that all new scientific findings can be easily identified on a single website.
While early results are still coming in, there are already important insights we can glean about the current state of research from the COVID-19 Trial Tracker. Delving deeper into these insights results in important new questions about global cooperation for clinical development.
On March 16, the World Health Organization (WHO) Director-General, Dr. Tedros Adhanom Ghebreyesus, in his media briefing on COVID-19, described the coronavirus pandemic as “the defining global health crisis of our time". The pandemic has affected 176 countries and territories around the world. WHO is urging all governments to scale-up aggressive measures to combat COVID-19 as more cases and deaths are being reported across the globe. Until a vaccine is made available, social distancing is of the utmost importance to reduce transmission and enable health systems to cope.
The U.S. Centers for Disease Control and Prevention (CDC) defines social distancing as “remaining out of congregate settings, avoiding mass gatherings, and maintaining distance (approximately 6 feet or 2 meters) from others when possible” . Governments in several countries have shut down public places such as parks, gyms, malls, schools, restaurants etc., for a minimum of 15 days, to be extended depending upon the situation.
In these circumstances, it is inevitable that companies worldwide also show solidarity by allowing their employees to work remotely, from the safety of their homes. In Seattle, the hub of many of America’s early COVID-19 cases, companies including Amazon, LinkedIn, Microsoft and Google advised workers to stop coming to office in late February . With more employers taking this necessary and precautionary step, the question arises - how do we ensure that it is done right?