Basket and umbrella protocol designs are becoming more prevalent in rare disease clinical trials because they can offer significant benefits in the development process however, they also introduce challenges necessitating strategic planning and careful execution. The diverse presentation of rare diseases complicate the standardization of endpoints, additionally, the subjective nature of some clinical outcomes may lead to varied interpretations by different investigators.
This webinar will examine the strategic advantages and statistical considerations or benefits of choosing either a basket or an umbrella trial design including increased research efficiencies and the ability to explore multiple therapies or rare diseases within a single trial structure. The team will also explore adaptive medical monitoring strategies that are crucial in supporting master protocol frameworks whilst ensuring the trial remains flexible and responsive to emerging data, enhancing the potential for success across various treatment arms.
Furthermore, effective management practices for multi-arm clinical trials will be explained, from logistical considerations to ethical implications, with an emphasis on optimizing patient recruitment and efficient data collection methods, ensuring that each trial phase is conducted with precision and in accordance with regulatory standards.
Join Allucent’s A-Team to gain a deeper understanding of how these advanced trial designs can be utilized not only to accelerate the development of therapies for rare diseases but also to address challenges and pave the way for improved patient outcomes.
TAKEAWAYS
- The trial design benefits and challenges presented by basket and umbrella trials.
- Insights into adaptive medical monitoring strategies crucial for supporting master protocol frameworks.
- Best practices for the effective operational management of multi-arm clinical trials.
- How employing these advanced trial designs can significantly accelerate the development of therapies for rare diseases
AUDIENCE
This webinar will appeal to VPs, Directors, Managers and Heads involved in:
- Clinical Operations/Clinical Research
- Biostatistics and Data Science
- Clinical Project Management/Trial Oversight
- Research and Development (R&D)
- Medical Affairs/Medical Writing/Pharmacovigilance
- Chief Medical Officers (CMOs) and CEOs of small and medium-sized biotech/pharmaceutical companies
- Quality Assurance/Compliance
- Regulatory Affairs/Strategy
SPEAKERS
Maria-Cruz Morillo — Global Head, Allucent Rare Disease Center of Expertise
Maria-Cruz Morillo, M.S. Pharmacy, has deep knowledge in drug development after 27 years of experience in Project Management and Strategy and IMP Supply in both biotech and CROs. Her strategic mindset and demonstrated ability to design and implement effective study protocols has contributed significantly to the achievement of market authorizations for numerous rare endocrinology and hematology autoimmune programs. Maria-Cruz is currently heading Allucent Rare Disease Center of Expertise, integrating our cross functional expertise to provide strategic solutions that foster successful outcomes in rare disease clinical trials and ensure excellence in delivery.
Milan Marinkov – Executive Medical Director, Rare Disease Medical Lead
Milan is an Executive Medical Director at Allucent with over 15 years of experience in the fields of clinical research and drug development coming from the industry and CROs. Focusing on rare and neuroscience diseases, Milan has played a pivotal role in the design, conduct and refinement of study protocols to optimize clinical research methodologies. He serves as a medical team leader, overseeing and presiding over steering committees, as well as evaluating risks and safety signals in numerous clinical trials. Currently, Milan is leading a team of medics dedicated to advancing research in rare diseases. Prior to venturing into the realm of clinical research, Milan pursued a career as a clinician and holds a medical degree, specializing in neurology and clinical pharmacology from the University of Belgrade.
Genevieve Wills – Associate Director, Biostatistical Consulting
Genevieve has more than 11 years’ professional experience in clinical trial research. As Associate Director, Statistical Consulting at Allucent, she is responsible for statistical consulting activities for Phases I-IV studies globally. This involves assisting sponsors to support clinical program development, protocol development, sample size and endpoint selection, regulatory interactions, exploratory analyses, scientific meetings, and executive decisions. Prior to her work at Allucent, Genevieve was a senior research fellow (assistant professor) at the Medical Research Council at University College London with a focus on infectious disease clinical trials.
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