In a recent interview with Cytel, Zoran Antonijevic, longstanding chair and leader of the DIA Adaptive Design Scientific Working Group, spoke about adaptive design methods. He gave us insights on how these methods can help achieve new levels of clinical trial efficiency and probability of success.
Cytel is conducting a webinar series that introduces biostatisticians to some of the more commonly used complex innovative trial designs. On May 20, 2020, Zoran Antonijevic joined us as a speaker at a webinar from this series, “Innovative Drug Development at a Glance - The Concepts, The Vision, & The Factors to Consider”. In the webinar, Zoran defines complex innovative trial designs, summarizes the potential benefits of each, and highlights key factors to consider when applying these techniques. Continue reading this blog for a summary of the webinar. Click the button to get free access to the webinar slides and recording.
Significant advances have been made to enhance the efficiency of clinical trial designs. However, the traditional methods deployed by many companies are fraught with challenges. Patients end up waiting a long time for therapies or receive suboptimal therapies. Millions to billions in revenue is sacrificed by delays to market, competitive shutouts, unfavorable product profiles, and unproven treatments. Even the best planned trials face uncertainties. Researchers using fixed trial designs may over-engineer these designs thereby increasing the cost of trial or incur the risk of failing to draw a meaningful conclusion.
Complex innovative designs enable researchers to mitigate uncertainty by pre-planning ways to adapt as they learn. These advanced designs have the potential to improve the probability of commercial success. They have demonstrated ability to accelerate delivery of therapies to patients in needs and improve the overall return on R&D investment. Moreover, long-standing complex designs already have regulatory acceptance, and regulators are paving the way for more innovation. The 2019 FDA Guidance focused on Complex Innovative Designs and highlighted that a common feature in many of these designs is the need for simulations because the trial operating characteristics cannot be calculated directly. Every design may not be appropriate in every situation and sponsors, when they are submitting these designs for review, need to specify the reason why the design is being proposed.
Zoran goes on to explain the journey from using traditional designs, that did not involve any interim analysis, to portfolio optimization. He introduces us to various adaptive designs that are being covered extensively by Cytel’s ongoing Introduction to Complex Innovative Trial Design webinar series. You can register for these complementary webinars by clicking on the button below.
Many companies are reluctant to use these innovative designs because they find them risky. The solution here is to objectify these risks and quantify them. Pharmaceutical companies of all sizes need to start building frameworks under which they can define the context, frame the problem, specify options and run simulations. Zoran explains the importance of portfolio level optimization and shows us what program level and platform level frameworks look like.
In the current times of COVID-19, innovative trial designs can help accelerate therapy development. The three ongoing platform trials, SOLIDARITY, ACTT and REMAP-CAP provide the ability to add additional treatments. Additionally, FDA and EMA are strongly recommending platform trials for development of COVID-19 treatment.
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About Zoran Antonijevic
Zoran Antonijevic is Head of Biometrics at MedSource. He held executive positions in Pharmaceutical Companies and CROs and has designed more than 100 clinical trials in numerous therapeutic areas, many of which included adaptive designs. Zoran is a long-time Chair and leader of the DIA Adaptive Design Scientific Working Group. He has authored numerous papers and scientific presentations and was editor of books “Optimization of Pharmaceutical R&D Programs and Portfolios” and jointly with Bob Beckman “Platform Trials in Drug Development”.