Archives: Agenda

• Understanding site processes and expectations to reduce delays in site initiation, activation, and screening for potential patients
• Championing collaborative sites for a streamlined trial
• Can we ever be appropriately equipped for adverse effects with off-site testing?

• Moving from basic functionalities to more meaningful impact and examples of this in practice
• When AI is progressing so quickly, how will regulation evolve to match this speed?
• When is AI not the answer?
• How AI has revolutionised innovative ways of collecting data, biosimulation, and early disease diagnosis for oncology trials

Foundation’s leadership role in the EU PEARL project

• Assessing the link between eligibility criteria and the potential for a serious adverse event to make an informed decision about potentially expanding the exclusion criteria of a trial
• Discovering alternative solutions to improve patient enrollment into trials
• Where are you getting your data for entry criteria?
• How have the increased pressures of patient recruitment led to changing and expanding your traditional enrollment methods? What are you doing differently to increase enrollment?
• Ensuring your entry criteria are not too conservative but remain safe so that you can reach real world populations
• What are the criteria that are major barriers for underrepresented minorities?
• How are you using AI to interrogate which criteria to change?

• Changing how researchers select potential patients for better success rates
• How to improve drug efficacy and patient safety before it’s too late
• Back to square one: Differentiating with simpler, patient-centric protocols and optimised study design
• Avoiding disappointing results by implementing the right technology tools to advance your trial
• Lessons learned to mitigate trial failures

Moderator: Sumeet Ambarkhane, Chief Medical Officer, Pathios Therapeutics