Insights into Covid-19 Working Group Efforts and Treatment Evidence
Explore the collaborative efforts of the Covid-19 Working Group, key members, historical contributions, sources of treatment evidence, and initiatives funded by NIH and Pharma. Delve into the setup, conduct, analysis, and lessons learned. Discover success metrics and the impact on patient treatments.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
You are allowed to download the files provided on this website for personal or commercial use, subject to the condition that they are used lawfully. All files are the property of their respective owners.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author.
E N D
Presentation Transcript
2 Nevine Zariffa (NMD Group, LLC) Joan Buenconsejo (Bristol Myers Squibb) Estelle Russek-Cohen (independent consultant) Freda Cooner (Arcutis) Margaret Gamalo (Pfizer) Samiran Ghosh (University of Texas Health Science Center) Ran Liao (Eli Lilly) Junjing Lin (Takeda) Pritibha Singh (Novartis) Fanni Natanegara (Eli Lilly) Jerald Schindler (Medtronics) Divya Lakshminarayanan (GSK) Members of the working group
3 History of WG efforts Natanegara, F., Zariffa, N., Buenconsejo, J., Liao, R., Cooner, F., Lakshminarayanan, D., Ghosh, S., Schindler, J.S., & Gamalo, M. (2021). Statistical Opportunities to Accelerate Development for COVID-19 Therapeutics. Statistics in Biopharmaceutical Research, 14, 5 - 21. Zariffa N, Russek-Cohen E. Vaccines After an Emergency Use Authorization (EUA): Modern Evidence Generation Approaches. Ther Innov Regul Sci. 2021 Jul;55(4):866-871. Chan I.S.F., Singh P., Schindler, J., Critical Elements in Communication of Vaccine Trial Results (DIA Global Forum, March 2021) International COVID-19 Data Alliance (ICODA): MS in progress Survey of platform trials for COVID-19: MS in progress
Covid 19: Sources of evidence for treatments Many real world observational studies Many small randomized trials Larger trials with one therapy tested Platform trials with multiple treatments .several treatments repurposed . .some trials for new therapies What have we learned? Are we ready for the next pandemic? 4
ActIV 4A : one of several funded by NIH. Community: funded by Pharma ISPY-COVID Many platform studies for Covid ReMap-Cap Principle Panoramic Solidarity (WHO) Recovery Together 5
Set-up (Design, Randomization, Bayesian, infrastructure) Conduct The questions Analysis and Results Lessons learned and key take-aways 6
Starting up: Building on existing infrastructure Finding collaborators Dealing with regulators Lessons learned Finding the right endpoints Provisions for evolution (SOC updates .) Speed matters and so does catching a wave Bayesian and frequentist: both are useful Attention to data quality: credibility? 7
Success metrics Papers published Actually impacting patient treatment? in timely fashion? RECOVERY finished Dexamethasone assessment (in hospitals) UK NHS implemented result in 4 hours US FDA agreed about a week later 8
Seeing pushback from NIH and FDA See article by Proschan and Evans (2020) describing concerns If you use it, prepare to defend it .concerns over how changing prevalence of covid strains impact comparisons? .concerns over changing standard of care? . Is it really better than competing designs? Is it really more ethical? Response adaptive randomizations
Where are we on platform trials? Which areas use platform trials now? Oncology, rare diseases, covid (incl vaccines) Umbrella trials: multiple products, one disease Who s the trial sponsor? Most covid studies are umbrella. If new products: negotiating with regulators? Basket trials: multiple indications, one product Oncology: Same drug, multiple tumor types If you want results to impact a label: talk with regulators beforehand. 10
What comes next? US and other countries need to prepare for the next pandemic: what infrastructure needs to be in place? how will data be collected, stored and shared? Platform studies can provide shared controls and provide the ability to screen treatments rapidly. what will regulators and funders want to see? get more players working together to avoid lots of small uninterpretable studies. Community acquired pneumonia or other respiratory could be a good target. 11
