Challenges and Considerations in Designing and Conducting Immuno-Oncology Clinical Research
Given the accelerating pace of I-O clinical research, awareness of the specific challenges and considerations in designing and conducting successful trials for these new agents is critical. Join experts from Medpace’s medical department, central lab, and imaging core lab in a discussion that reveals lessons-learned, best practices and the importance of considering the most appropriate biomarkers, safety testing, and imaging needs early in the planning process.
Key topics for discussion include:
1.) Medical and operational considerations
Applying experience from managing numerous I-O clinical studies, discussion will cover how to successfully address these issues by:
- Carefully considering eligibility criteria
- Designing timely site communication
- Maintaining research subject calendars
- Employing standard guidelines developed for the assessment of disease response and toxicities
2.) Biomarkers and testing considerations
I-O biomarkers that address this interplay between the immune system and the tumor belong primarily to four key areas. Each of these will be discussed:
- Tumor antigens
- Inflamed tumor markers
- Immune suppression markers
- Host environment factors
3.) Imaging considerations
- Types of imaging that are useful as end-points in immuno-oncology trials
- I-O imaging-related response criteria including Response evaluation criteria in solid tumors (RECIST), irRC, irRECIST, and iRECIST
- Nuclear medicine imaging and I-O response criteria including PERCIST and Lugano
- Optimization of database structures for imaging endpoints in I-O trials including how to structure EDC and eCRF
