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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Advancing Clinical Trials: A Deep Dive into Bayesian Interval-Based Designs for Phase I Dose-Escalation Trials
Jun 28, 2024
As a global provider of advanced analytics, technology solutions, and contract research services to the life sciences industry, IQVIA is always at the forefront of leveraging cutting-edge methodologies for clinical research. In line with this commitment, we are pleased to share our latest joint research paper titled "Bayesian Interval-Based Designs for Phase I Dose-Escalation Trials: A Case Study in Oncology."
The objective of Phase I trials is to determine the maximum tolerated dose (MTD) or optimal biological dose (OBD) of a new drug. With the advent of novel molecular therapies, the FDA's Project Optimus initiative has highlighted the need to consider the efficacy of a drug in relation to dosage rather than focusing on the MTD alone.
Our joint research explores the potential of Bayesian interval-based designs, in addressing these challenges. This approach uses probabilistic models and prior knowledge to adaptively adjust dosage levels, enabling a more precise estimation of the OBD.
However, our research goes a step further by using a real-life case study to demonstrate the efficiency of a modified BOIN12 design that combines toxicity information with efficacy rates. This modified approach is shown to be better suited for trials with a benign toxicity profile, aligning perfectly with the objectives of Project Optimus.
In addition to the theoretical benefits, our research also delved into the practical considerations for implementing Bayesian interval-based designs for dose optimization in real-world trials. We discussed several factors including determining priors, handling late-onset toxicities, and managing dropouts, thereby offering valuable insights for trialists.
This research is a significant stride towards enhancing the efficiency and ethical conduct of Phase I dose-escalation trials by considering the patients’ benefit/risk profile. It will have a profound impact on the development and approval of new oncology treatments.
At IQVIA, we are committed to innovation and the application of advanced methodologies that can accelerate the process of bringing new treatments to market. Our exploration of Bayesian interval-based designs for dose optimization underscores this commitment.
We invite you to examine this research in detail here: https://www.longdom.org/open-access/bayesian-interval-based-designs-for-phase-i-doseescalation-trials-a-case-study-in-oncology.pdf
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