Practical solutions for regulatory hurdles, statistical design challenges, and data integration
Adaptive randomization, interim analysis, and effective patient recruitment
FDA’s push for two doses into Phase 2 (Project Optimus)
Increase in BOIN trial designs
Requirements of PK & PD data to serve the cohort review committees
Cohort planning and practicalities of running this across multiple sites/countries
Discussing clinical trends and developments in oncology trial research
Analyzing current strategies and ways to increase clinical patient beneficial results in oncology trials
How sponsors can navigate new regulations amidst current restrictions in clinical cancer trials
How living with cancer impacts ability to participate in clinical trials and what can be done to relieve burden on patients
Insights into a patient’s trial experience while undergoing multiple tests for their illness
How to alleviate financial burden on patients participating in oncology trials
Focusing on protecting patient data and security during trials
Increasingly pharmaceutical companies are committing to reducing their carbon footprints in the execution of clinical trials.
A more efficient and effective clinical trial supply chain can be created by implementing new clinical supply technologies and sustainable processes.
Today’s presentation explains how implementing innovative processes and technologies
Results in a more efficient use of human resources
Reduces the amount of logistical resources required
Saves money
Lowers the carbon footprint impact
Benefits of using UCSF IRB for reviews of oncology research
Describing how UCSF new consent form and process of inviting investigators to IRB meetings have been successful at streamlining review and approval of oncology studies.
What can sponsors do to improve IRB time to approval?
Measuring clinical trial carbon emission footprints
Identifying emissions hotspots and decarbonization initiatives
Aligning with key partners (e.g. CRO, Central Lab)
Incentivizing the organization
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