Reinforcement Learning (RL), a crucial component of machine learning (ML), serves as a remarkable framework for identifying a sequence of actions aimed at increasing the likelihood of accomplishing a predetermined goal. RL has been widely used in the fields of gaming and robotics, with notable instances including its utilization in defeating a world champion program in chess, shoji, and Go.1 In recent years, RL has gained significant attention in the healthcare sector, particularly in the domain of clinical decision-making and the optimization of treatment regimens.
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One of the lesser-known complications associated with Multiple Sclerosis is a higher risk of serious infections (SIs). Cytel’s RWE experts conducted a retrospective analysis of claims data to determine the incidence of SIs among people with various types of MS. Let’s take a closer look at this method:
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By Grammati Sarri, Evie Merinopoulou, Vinusha Kalatharan, and Jason Simeone
The Canadian Agency for Drugs and Technologies in Health’s (CADTH) long-expected guidance on real-world evidence (RWE) is now in the public domain; however, it solely provides standardized (core) reporting practices for manufacturers submitting RWE studies to support their drugs applications, and important aspects of the incorporation of RWE in decision-making are missing.
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Legislation on pediatric studies has existed for more than 20 years in the US, yet additional guidance from the FDA has been relatively scarce. However, two new draft guidelines have now been published, including policy changes that may affect current opportunities for pediatric exclusivity and when data may be extrapolated from adults. How might this affect pediatric drug development? Read more »
Real-world data has been increasingly used to answer questions related to the course, prognosis, and treatment of multiple sclerosis – yet each data source has its limitations, restricting the questions that can be addressed. Here is our solution.
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Written by Natalia Muehlemann, Vice President, Clinical Development; Martin Frenzel, Research Principal, Statistical Consulting; and Michael Fossler, Vice President, Clinical Pharmacology
The importance of dose selection and early phase clinical trial design was on the scientific agenda of the ESMO (European Society of Medical Oncology) Congress, which took place on October 20–24, 2023, in Madrid, Spain. Speakers discussed investigator, regulatory (FDA), industry, and patient perspectives during the special symposium “Challenging the Status Quo of Early Phase Clinical Trial Design: Project Optimus.”
Highlight of ESMO symposium “Challenging the Status Quo of Early Phase Clinical Trial Design: Project Optimus”
Historically, the dose range of oncology drugs has been inadequately characterized prior to approval, leading to many post-approval dose changes in the labelling. Most of these post-approval changes have been overall decreases in dose. To address this challenge, the FDA Oncology Center of Excellence initiated Project Optimus. Since its launch in 2021, Project Optimus has been reforming the dose optimization and dose selection paradigm in oncology drug development. With consensus of multiple stakeholders on “why” the change is needed, the speakers focused on “how.” The key paradigm shift includes:
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The spotlight for this year’s World Evidence-Based Healthcare Day (EBHC) (October 20, 2023), is on the generation and application of evidence to improve global health equity.
According to the World Health Organization (WHO), “health equity is the absence of unfair, avoidable or remediable differences in health among population groups, defined by social, economic, demographic or geographic characteristics.”
Health inequity (or disparity) is not a new health topic; it has been widely documented across the world for the last four decades. What is new are the recent efforts to make health equity a strategic priority in healthcare decision-making. A couple of things are clearer now more than ever — 1) there is a need to
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Interest and appetite for master protocols is growing as sponsors consider opportunities in various therapeutic areas beyond oncology. During initial discussions, most quickly recognize the potential operational and inferential benefits of a master protocol; however, as sponsors dive deeper into the details, doubt creeps in and there are a multitude of reasons expressed for not moving forward with a master protocol. Here are some common myths and the facts around them:
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The Inflation Reduction Act (IRA), passed in August 2022, marks a significant shift in the US healthcare landscape, particularly for Medicare. The IRA introduces reforms to Medicare’s prescription drug program (Part D), inflationary caps in Medicare (Part B), and Medicare price negotiation. To effectively navigate these changes, pharmaceutical companies must develop robust evidence-generation programs that support evolving value requirements throughout a drug’s life cycle. Read more »
In the ever-changing field of clinical trial design, there is often a need to evaluate design options quickly and efficiently. But when it comes to evaluating options, which is better: commercial or open-source software? And does it need to be a question of either-or? Read more »
