The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
The COVID-19 Pandemic prompted the rapid surge in the generation of clinical data that has been scattered across multiple platforms, making it challenging to measure comparative treatment effects across trials. Last year, Cytel launched a COVID-19 Trial Tracker, an Open Access tool to track the global response to the pandemic. We talk to Louis Dron, Director - Real World Analytics at Cytel, about the evolution of Cytel’s Trial Tracker and the vision for its future developments.
Cytel’s COVID-19 Trial Tracker continues to provide real time updates to the status of COVID-19 clinical trials worldwide. Funded by the Gates Foundation, the COVID-19 Trial Tracker uses machine learning technology to ensure that registries across the world feed into the Trial Tracker.
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. 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 clinical trials taking place in the international effort to tackle the pandemic.
We have been posting regular updates on the clinical development of COVID-19 therapy and vaccines, on Cytel’s Blog page. The following details are based on an updated data search accessed on January 11.
The Cytel COVID-19 Trial Tracker brings you an up to the minute, real time dashboard about COVID-19 trials around the world. This snapshot gives you a quick briefing on the current state of COVID-19 therapy and vaccines development.
An extraordinary amount of global research is underway as the COVID-19 pandemic continues to evolve and spread. As several entities develop curative and preventive responses against COVID-19, alignment with regulatory recommendations is key for developing effective and safe intervention. Moreover, fast regulatory approval will translate into early availability of interventions to address unmet needs.
Continue reading to get an overview of the registered COVID-19 clinical trials landscape, with a story on the special attention received by Hydroxychloroquine treatment.
Virtual ISPOR 2020, held November 16 to 19, presented new opportunities for scientific interaction amongst HEOR community. Cytel and Ingress Health, now a Cytel company, contributed to a range of events including interactive workshops, issue panels, on demand podium presentations and virtual poster presentations.
Continue reading for discussions on tracking COVID-19 trials, reflecting on the successes, opportunities and failures of real world solutions, and bridging the gap between real world data and clinical development.
TOGETHER trials, and the advantages of adaptive platform designs for investigating COVID-19 therapies
Cytel has recently designed and implemented the TOGETHER Trials, funded by the Bill & Melinda Gates Foundation to generate knowledge to help fight COVID-19, particularly in low and middle-income countries. The trials, with sites in Brazil and South Africa, test three existing interventions as possible treatments for COVID-19 in high-risk adults who do not require hospitalization, compared to a placebo.
The TOGETHER trials use an adaptive platform design. This type of design is particularly useful for contexts such as COVID-19 response, where there are many unknowns and a need for accelerated and resource-efficient answers, for 5 reasons.
The TOGETHER Trial: Cytel Designs and Implements Novel Adaptive Platform Trial for COVID-19 Therapies
Cytel has designed and implemented a novel adaptive platform trial for early stage COVID-19. The severity of the coronavirus emerges in five stages, with the majority of clinical trials focusing on therapies for the final stage of the disease. According to the Cytel Clinical Trial Tracker, only 6 of 2000 trials are focused on early stages; staggering given that only 5% of coronavirus cases are considered severe.
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 (1570 as on today, according to the Cytel Global Coronavirus COVID-19 Clinical Trial Tracker1).
Moreover, the pandemic impacted the regular schedule of ongoing clinical trials. Health authorities such as the FDA, promptly provided recommendations in the form of questions and answers on how to handle “disruptions” due to the pandemic2. These disruptions include a range of challenges including skipped assessments or study withdrawal.
“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 …. The task force was launched with the goal of developing Interim User Guide and Related material” said David Bobbitt, CDISC CEO, in an interview with Outsourcing-Pharma.com3. On April 21, 2020, the task force released two guidances. In this blog, I provide you with a quick summary of what these guidances address.
The two guidances are:
- Guidance for Ongoing Studies Disrupted by COVID-19
- CDISC Interim User Guide for COVID-19
Continue reading to learn more.