Lunch & Learn in South San Francisco, CA

April 25, 2024

Tower Place, San Francisco, CA

REGULATORY AND DESIGN TRENDS IN CLINICAL TRIALS

IDDI and OWL Oncology Research are pleased to invite you to an exceptional lunch and learn on trends in clinical trials:

THURSDAY, APRIL 25th | 11:30 – 2:00 PM | Tower Place – South San Francisco, CA 

WHAT YOU WILL LEARN:

Our Life Sciences Industry moves in a dynamic and volatile landscape and needs to constantly adapt to new challenges and opportunities. This complementary lunch and learn will be a UNIQUE opportunity to understand how a clinical CRO, OWL Oncology and a Biometry CRO, IDDI, can together help biotechnology and pharmaceutical companies navigate through the intricacies of a clinical trial journey.

• • OWL Oncology Research speakers will develop the geopolitical context of clinical trials by tackling the global regulatory trends and more particularly why Clinical Trials Information System (CTIS) put in place by EMA is not always straight forward as it would appear, and which are the clinical trial-friendly countries. They will also discuss novel approaches that are being tried in our industry to support the drug development process.
  • IDDI Inc speakers will provide an overview of the new draft FDA guidance on Data Monitoring Committees (DMCs) published in February 2024 and develop the concepts of adaptive trial design using constrained (optimal) promising zone (CPZ) methods and the operational challenges for Sponsors and Independent Data Monitoring Committees (IDMC).

• Functional service model provider model in early phase clinical trials
• Global regulatory trends in clinical research
• The importance of risk management in regulatory submissions
• Adaptive trial design using constrained (optimal) promising zone (CPZ): Operational challenges for Sponsors and IDMC
• Overview of new draft FDA guidance on IDMCs
• Key operational chalenges of sample-size re-assessment methods

SPEAKERS:

• ADAPTIVE TRIAL DESIGN USING CONSTRAINED (OPTIMAL) PROMIZING ZONE (CPZ) METHODS AND OPERATIONAL CHALLENGES FOR SPONSORS AND IDMCs

Tara Kervin, MPH: VP, Global Operations & Consulting; VP, IDDI Inc. and Vincent Staggs, PhD: Senior Scientist, Statistical Consulting, IDDI Inc.

• Building on work by Mehta and Pocock (2011) and Jennison and Turnbull (2015), Hsiao et al. (2018) proposed a constrained (optimal) promising zone (CPZ) design that includes an interim analysis to decide whether the sample size should be increased, and if so, by how much. Independent Data Monitoring Committees (IDMCs) are often entrusted to review sample size re-assessment interim analyses and make according recommendations to the Sponsor.
• Commentary is provided on use of the CPZ design in practice, including situations where the gain in overall power may make the approach more/less compelling. 
• An overview of the new draft FDA guidance on DMCs (published February 2024) will be given, highlighting how it differ from previous FDA materials (March 2006), including an emphasis on independence and access to all data to make comprehensive risk/benefit decisions.
• The markers of a good and competent independent statistical reporting group to best support an IDMC in charge of reviewing an interim analysis or other trials with complex designs will be described.
• The key operational challenges of sample size re-assessment methods and best practices to minimize the risk of introducing operational bias is presented.

• FUNCTIONAL SERVICE MODEL PROVIDER IN EARLY PHASE CLINICAL TRIALS

Joseph Mudd, MSHS, CCRA: Managing Partner / Co-Founder, OWL Oncology Research

• Defining the Functional Service Provider Model
• Pros and Cons of the FSP vs. CRO Model
• Identification and Implementation of FSP Vendors
• Case study

• EU CLINICAL TRIAL REGULATION (EU No 536/2014) CTIS – A CLINICAL OPERATIONS PERSPECTIVE

Christine Marlow-Barker, RN: Clinical Operations Consultant, Strategy and Quality Assurance

• General Timelines
• Redaction/anonymization efforts
• impact of combined country approvals versus historically independent country approvals
• Case study 2023 Phase 3 submission

We hope you will be able to join us! 

SEATS ARE LIMITED –  Register by April 18th to save your seat! 

About OWL Oncology Research, LLC:

OWL Oncology Research®, a Functional Service Provider (FSP), is a global network of hundreds of experienced clinical research experts specializing in oncology and rare disease trials. We deliver the highest quality clinical trial resources to the pharmaceutical and biotechnology industries. Our commitment is to ensure that your clinical trials are conducted effectively and efficiently so that new and promising treatments become available to the millions of people battling these diseases.