What’s Ahead for Clinical Trial Design?
The past two years have been transformative for Cytel. Most notably, the global COVID-19 pandemic unleashed an industry-wide tidal wave of challenges in clinical trial conduct, the ripple effects of which were felt across workstreams, project timelines, and other deliverables. In response, our company expanded considerably during this time, meeting the challenges with new scientific and product offerings. They include Solara, a new SaaS platform that harnesses massive cloud computational power to assist teams in selecting the best design for their studies; innovative Bayesian trial designs only found in East Bayes; LiveSLR, a web software product that defines a new standard for human-machine partnership to expedite and standardize HTA submissions; and over 200 scientists worldwide working to leverage real-world data and create value evidence across the pipeline from natural history studies to market access.
Perhaps most important to me are the critical conversations which these scientists undertook with the wider scientific community in 2021, and which will undoubtedly continue throughout 2022. We published over 40 articles in leading journals and contributed over 75 posters and presentations at a diverse set of industry forums and conferences. We are also delighted that you chose to attend Cytel’s webinars in 2021 in great numbers to learn and discuss a range of topics covering among other things Bayesian Methods, synthetic and external control arms, financial methods for clinical trial design and strategy, and a celebration of the 10 Year Anniversary of the Promising Zone. Our thought-leaders have been interviewed for numerous industry-publications, and in fields as varied as master protocols and scientific computing.
It is these conversations on innovation that I look forward to continuing in 2022. Some areas where I believe the industry will make significant headway this year, and where I expect much activity from Cytel scientists include:
- More Innovative and Accessible Bayesian Methods: As we educate the broader industry and scientific community on their merits, Bayesian methods are becoming more popular, accepted, and more critical for strategic clinical research. Their usage ranges from the design flexibility provided to meet the multiple objectives of early phase studies, to the historical and external data and information borrowing mechanisms that strengthen late-phase regulatory dossiers. As new variants of COVID-19 arose, Bayesian methods have also played a key role in salvaging disrupted clinical trials. In 2022 Cytel will continue to popularize methods invented by our scientists, while releasing software making these and other methods more widely accessible.
- Greater Collaboration Between Clinicians and Statisticians: Cytel is set to release a suite of tools in 2022 that will enable clinicians to directly pressure test their study design, and easily look for better designs when leading their products to market. (More on the release to come). The recent appointment of my colleague Dr. Albert Kim as Cytel’s first Chief Medical Officer will ensure that dialogue between clinicians and statisticians strengthens through all of Cytel’s offerings as well as its forum of webinars, podcasts, articles and blogs.
- Strategic Uses of External and Historical Data for Regulatory Submission: The use of external and historical data for regulatory submissions has been on the rise. Cytel will continue to champion methods that strengthen decision-making and submissions packages by leveraging historical borrowing, synthetic and external control arms, and the relatively new field of quantitative bias analysis where Cytel scientists have recently made significant strides.
- Advanced Multiarm and Platform Trials: A couple of years ago, Cytel founder Cyrus Mehta predicted that multi-arm and platform trials will transform from coordinated efforts between universities and NGO’s, to platforms providing more commercial opportunities with these complex designs. Cytel is committed to helping pharmaceuticals and even groups of smaller biotechs, explore this option.
These are a few of the exciting elements of Cytel’s research and product portfolio. We will also be continuing to make headway in early phase trials, precision medicine, statistical genetics, real world evidence, and financial strategies for program and portfolio development. Come find us at our webinars and events, follow us on Twitter and LinkedIn, and please don’t hesitate to reach out to me and my colleagues if you have further questions.
About Yannis Jemiai
Yannis Jemiai has a pivotal role within Cytel as Chief Scientific Officer he has oversight for the corporate-level Scientific Agenda which includes establishing research portfolios in Bayesian, small sample, and other flexible designs; as well as complex innovative designs including adaptive trials, master protocols and MAMS. Yannis also has an extensive portfolio of research in adaptive trial design, financial and pharmaceutical strategy, decision theory, and regulatory affairs.
His own research has been published in numerous statistical journals. Dr. Jemiai earned his Ph.D. from Harvard University, an M.P.H. from Columbia University, and a B.A. in Molecular and Cellular Biology also from Harvard.