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Explore Advanced Clinical Trial Design
Purpose
To advance the science of trial design and therapeutics development.
Mission
History of Design Innovation
Pre-Founding: Small Sample Methods
Professors Cyrus Mehta, Nitin Patel and a number of their students were challenged by renowned statistician Marvin Zelen, to see if they could design clinical trials with smaller population samples. Two innovations spearheaded this initiative: the wider use of early computing technology, and the methodological innovations in Operations Research and Combinatorics that this opened up. Cytel's early scholars began to publish in small sample methods (exact methods), Bayesian methods and other operations research, and eventually received SBIR grants to operationalize their research for the industry.
Founding and Early Days
Cytel is founded in 1987 with an SBIR grant to bring StatXact to market. StatXact continues to be used for calculations of small samples and is now the most expansive toolkit for small sample methods available in the industry.
Cytel Software Becomes Industry Leader
In the early 1990s, Cytel's thought leadership focused on making small sample designs widely available in industry to expedite clinical trials. Wider access to software meant products like East, StatXact and LogXact hit the market and created the first generation of technology-enabled clinical trials. At the same time, Cytel's scientists and statisticians continued to publish in innovative methodologies including Bayesian, Group Sequential and exact small sample methods.
Cytel Becomes Leader in Adaptive & Group Sequential Designs as well as Biometrics Solutions
Cytel consolidates its position in adaptive and group sequential trials with dozens of publications. It also expands its biometrics services with offices in South Asia (Pune & Hyderabad), Switzerland (Geneva), and Western Europe (Paris, Barcelona and Lyon).
Second Wave of Adaptive Designs
The second wave of adaptive designs to take shape in the industry included sample size re-estimation designs, enrichment designs, seamless phase designs, and more. Adaptations began to include changes to endpoint, changes to the number of trial arms carried forward, and the earliest attempts to tie design to decision sciences. This era also included the development of the Promising Zone design. Invented by founder Cyrus Mehta and colleagues, this simple design ensures that new medicines do not fail to receive regulatory approval simply because the study is underpowered.
Making Complex Methods Accessible
In this era innovative trials became more widespread, available to biotechs for the first time. Cytel designs a number of trials including a promising zone design for the VALOR trial in relapsed/refractory Acute Myeloid Leukemia, and the endpoint adaptation for EXAMINE a trial for cardiovascular outcomes in patients with diabetes. Cytel also began to build the bridge between design and strategy with key publications in Bayesian decision-making. East® releases a number of modules to empower statisticians to create complex, innovative and novel designs. This includes East Enrichment to create population enrichment designs for biomarker driven trials; as well as East Escalate for improved dose-finding; and Multi-arm Multi-stage trials that facilitate seamless Phase II/III designs.
Cytel Releases EnForeSys
Cytel releases Enforesys, which applies advanced knowledge of Monte Carlo methods to enrollment and feasibility forecasting. In doing so it presents a way to utilize simulations-based solutions to reduce enrollment uncertainty, which according to JAMA was the foremost reason for trial discontinuity at the time. These simulations enabled sponsors to forecast enrollment while accounting for variability at the site level; model fluctuations in enrollment rate for improved targeting; and build a more accurate, data-driven feasibility strategy with Monte Carlo modeling.
25 Years of Confirmatory Adaptive Designs
As a part of the global celebrations of 25 years of adaptive confirmatory designs, Cyrus Mehta publishes seminal paper reviewing the leading clinical trials with Adaptive Designs. The EXAMINE Trial, a trial for cardiovascular outcomes in patients with diabetes, was the first to change an endpoint as a part of the interim adaptation. Read more in the published results.
A New Chapter
Cytel is acquired by New Mountain Capital. As it consolidates its commitment to adaptive, Bayesian and innovative designs, it also begins to turn to its next phase of growth into real world solutions.
Cardiovascular Health Takes Center Stage
Cytel publishes extensively on Cardiovascular Health and Diabetes, looking more closely at how design considerations and choice of clinical endpoints can build efficiencies in bringing new medicines to market.
Next Generation of Advanced Quantitative Solutions
Cytel expands into real world data and real-world evidence by acquiring Lighthouse and MTEK. This brings more basket and platform trials under its belt. This solidifies capabilities in historical borrowing, trial emulation, Bayesian modeling, single arm trials, natural history of disease, and other innovations. Cytel also makes its first foray into Global Health and epidemiology.
Thought Leadership during COVID-19
Cytel acquires Laiya Consulting, strengthening thought-leadership in Bayesian statistics, particularly early phase. It expands its real world solutions and health economics outcomes research by acquiring Ingress Health and Purple Squirrel Economics. It makes forays into platform trials with many new scientists joining Cytel, as well as providing public webinars on the topic. It also publishes one of the earliest industry primers on operationalizing basket and umbrella trials. Once COVID-19 occurs, Cytel publishes several guidelines on how to protect and rescue ongoing clinical trials, as well as builds the COVID-19 Trial Tracker.
Strides in Simulation-Guided Design (Solara), Bayesian Methods & Platform Trial
Cytel releases Solara, the industry's first-to-market clinical trial strategy platform for simulation-guided clinical study design and selection. It also unveils East Bayes, which includes new Bayesian dose-finding methods curated by Cytel statisticians. It designs the TOGETHER Trial for finding affordable COVID-19 therapies in low and middle-income nations and is named a finalist in the Edison Awards.
Science of Trial Design
The Cytel Design Institute is born! The CDI’s mission is to programmatically capture, illustrate, and develop Cytel’s thought leadership in the innovative application of science and analytics (design science). In so doing, we seek to accelerate development of new therapeutics and improve clinical development success rates, cycle times and cost return on investment efficiency. By 2022 Cytel designed the TOGETHER Trial, a COVID-19 platform trial which won the Society of Clinical Trials best trial award. It also won the Fierce Life Sciences Award in Technology Innovation for its clinical trial strategy platform, Solara.
Our Latest Thinking
Novel designs that use adaptive, Bayesian and other innovative methods play a key role in clinical trial strategy. They can increase trial efficiency, bolster power, support resource allocation and reduce costs. Strategic use of these methods enhances the likelihood of identifying a true clinical benefit which ultimately accelerates patient access to effective therapeutics. Evolving technologies, novel statistical methods, increases in computational power, and the evolving Regulatory Framework enable and encourage innovative development approaches.
Cytel has pioneered several of the most commonly used Bayesian and frequentist Adaptive Methodologies in practice today, with customer success stories spanning the design, submission, and execution of complex innovative trials, including adaptive pivotal trials leading to FDA and EMA product approval. We help our clients to improve trial pre-planning, and achieve greater trial efficiency, safety, knowledge, and outcomes. We demonstrate ways to identify opportunities while maintaining full scientific rigor.
Innovative Designs are applicable to both exploratory and confirmatory trials for drugs, biologics, devices and diagnostics. Complex Innovative Designs allow for more efficient use of resources and better management of uncertainties such as treatment effect size, variability, population, doses and clinical endpoints. Using Bayesian and frequentist methodologies we identify the most appropriate design to meet your specific trial, program and portfolio needs.
Meet our experts
Publications
Access a comprehensive list of Cytel publications over the last decade.
Library
Discover our library with case studies, white papers, eBooks, etc.
Perspectives
Découvrez les informations et les tendances du secteur dans nos derniers articles de blog.
Heures d’ouverture
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Actualités et événements
Restez au courant de nos actualités et des événements à venir.
Innovative Design
Sample Size Reassessment (SSR) and Adaptive Population Enrichment
Population enrichment helps to identify high responsive groups and detect treatment effect with smaller sample sizes.
Group Sequential and Promising Zone Approach
We have expertise in the planning of confirmatory oncology trials where there are correlated endpoints of Objective Response Rate, Progression-Free Survival and Overall Survival.
Bayesian Methods and Historic / External Data in Confirmatory Designs
Bayesian and Hybrid confirmatory designs using historical / external data have been mainly applied in the development of medicines for rare diseases and medical devices.
Master Protocols
In the last few years, trial investigators have been showing interest in biomarker-guided trials such as basket trials and umbrella trials, developed under the master protocol framework.
Recent Innovative Design Projects
Since 2020, we have seen a marked increase in both the adoption and sophistication of adaptive trial designs. Innovations are present across therapeutic areas and throughout the development cycle from early dose finding to late-stage confirmatory studies.
Recent Innovative Design Projects depicted below.
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