Interim analyses (IA) are an essential part of clinical trials that—as a form of adaptive design—can help sponsors make informed decisions about whether to keep a trial going or discontinue it entirely. Join Rho’s Brett Gordon, Ben Vaughn, and Scott Mollan for this Q&A roundtable that will cover some of the most frequently asked questions they get from pharma companies about interim analysis.
If you were born during the Spanish flu of 1918, you had a 2-3x higher risk of Parkinson’s. If COVID-19 caused the same viral damage, what does that mean for all of us? In this webinar, study author Pete Schmidt, PhD (Rho) and Mark Stacy, MD (MUSC Health) discuss the new study and what biopharma sponsors should know about its implications for future movement disorder research.
Nine out of 10 clinical trials for new drugs fail; Oncology drugs have a 3.4 percent probability of succeeding. Still, cancer drugs can and are being commercialized. From 2003 to 2020, 124 oncology therapies were approved by FDA. What makes this possible? Knowing the key factors to consider at each juncture of development is critical to build the right roadmap for your product. In this webinar, you will learn how examining each step of drug development helps sponsors find success for cancer therapies. Topics include: 1. How to fill gaps and avoid pitfalls of oncology drug development. 2. The importance of early phase planning, from optimum dosage to formulation, 3. The role of end-of-phase planning, such as regulatory feedback.
Patient advocacy is vital for advancement in managing disease. We met with Chandrabali Ghose-Paul, Chief Scientific Officer, Emily’s Entourage and Gary Joyner, Chairman Emeritus, Board of Directors, Primary Ciliary Dyskinesia (PCD) Foundation to discuss the role of patient advocacy groups in clinical research. In this webinar, we discuss building the gap between research and patients and how to support patient advocacy in our community.
Personalized medicine has a complexity problem. In Parkinson’s, this complexity problem is far-reaching and access-limiting. Dr. Schmidt presents his insight from bench research, clinical trials, and care workflow optimization to explore how optimized clinical trials can expand access, improve care, and pave the way for more regionally diverse innovations in Parkinson’s.
It’s in the collective best interest of research sponsors, participants, and sites to get clinical trials up and running faster and with the right safety surveillance mechanisms in place. But all too often, challenges and complexities stand in the way of efficient trial activation, enrollment, and post-activation monitoring.
However, there’s an opportunity to overcome these barriers with a reimagined take on data reporting: We know that existing data can get lost and underutilized beneath piles of raw numbers. That’s where data visualization comes in—giving datasets the structure they need to be seen and put to action for more efficient clinical research.
Study start-up sets the foundation for success of your clinical trial. There are many considerations for vendor selection and partnerships during development and start-up. With these come challenges: complex protocols, gaps in site expectations, problems with enrollment and retention, etc. To combat these challenges and improve the chance for success there are several important concepts to keep in mind in the context of decentralized trials.
Expanded Access can be leveraged to advance and even accelerate clinical development of treatments for serious or life-threatening conditions. This webinar examin
UNITY Biotechnology partnered with Rho to execute a complex and fast-moving Osteoarthritis program with three concurrent clinical trials and database locks scheduled during the height of the COVID-19 pandemic. In this webinar, hear from both the Sponsor and CRO about the creative solutions they implemented and how they worked together to pivot quickly and meet critical study timelines in the midst of the pandemic.
The US FDA’s Breakthrough Therapy Designation, Regenerative Medicine Advanced Therapy Designation, Accelerated Approval Program, Priority Review, and Fast Track Designation can reduce your product’s development and approval timelines if pursued at the optimal time and implemented appropriately. Taking the time to understand the requirements and potential benefits of each acceleration mechanism will help you make informed decisions about the timing and planning for each of these opportunities and determine what is best for your product’s development program.