We held our 2025 Annual Meeting on November 4th in Washington, D.C. Throughout this summer and fall, Friends convened three working groups involving leading experts across government, academia, industry, and advocacy community to explore three emerging challenges in oncology clinical trials and drug development. Friends Advisory Advocates were involved in the regular working groups, contributed to the corresponding white papers, and served as panelists during our Annual Meeting and Advocate Webinar. Below, we have included perspectives from the patient advocates who were instrumental in shaping this work:

Session 1 – Seamless Trial Designs for Rare Cancer Drug Development

Speakers discussed how adaptive, seamless trial designs can improve efficiency in rare cancer trials while maintaining scientific integrity. These approaches have the potential to accelerate patient access to therapies when traditional randomized trials are not feasible. 

“For the condition my son had, the prognosis was 9 to 12 months after diagnosis. There isn’t enough time to wait for a Phase I study to finish before starting a Phase II. We lived through that waiting, and we don’t have the luxury of that time. Seamless trials make so much sense because they combine safety and dosing work in one continuous process. If there’s a positive signal, you can expand quickly and give families hope sooner.”
– Misha Mehta 

Read the Seamless Trial Designs white paper here. 

Session 2 – Trial Designs for Combination Drug Development 

The panel examined how regulators and researchers can more effectively assess the contribution of effect of each individual drug within combination regimens. Speakers examined statistical approaches, innovative design models, and how to ensure patient centricity in combination trial planning. 

“I think it was just a wonderful thing, right from the beginning, that we said patients should be at the center of what we discussed — that patient centricity was so important. [..] It’s essential to reassure patients that when they’re randomized in a trial, it’s in their best interest: there will be no harm, and only new knowledge and potential benefit can come from that. We need to keep that in focus.  Someone on one of the last panels said, ‘Time is money, but time is life.’ And I think that captures what’s so important here — the urgency of understanding what treatments are contributing to effect, and how this can benefit patients without causing harm.”
– Carol Vallett

Read the Combination Drug Development white paper here. 

Session 3 – Control Arm Selection for Multi-Regional Clinical Trials (MRCTs) 

Global oncology trials frequently encounter challenges due to variations in standards of care across different regions. This session highlighted methods to ensure control arms are scientifically sound, regionally appropriate, and globally consistent. 

“You want to have a standard of care that reflects the current treatment, and is modifiable based on clinical benefit. We discussed wanting to be able to modify, but how does that actually happen? Because it’s not always feasible to change that standard of care midstream, that requires flexibility and transparency… We don’t want any of those patients to get suboptimal care if they’re assigned to that arm of the clinical trial where the standard of care becomes obsolete.”  
– Susan Rouse

Read the MRCTs white paper here. 

If you missed Annual Meeting watch here or the Advocate Webinar watch here.