Congratulations on launching this important work, Adam. If you ever want to bounce expert/relevant parties elicitation ideas, I'd be delighted to be a sounding board.
Hi Adam! Not sure if this aligns with what you're looking for, but I produced a documentary exploring the extreme consequences of FDA bureaucracy delaying important therapies for conditions like blindness and cancer, and how startup cities and free zones are emerging as powerful alternatives.
I’d love to hear your thoughts on it, and if it resonates, would be great to chat about potential collaboration.
I am happy to weigh in — we tried a similar initiative at ASCO RCF about 6 years ago but got grounded by Covid. We had FDA, industry and CROs in attendance.
From the community side, the pain points are pretty consistent.
A lot of it starts with eligibility. Many studies are still written for an idealized patient who rarely walks through our doors. Normal organ function, minimal comorbidities, no prior malignancies, limited brain involvement, no autoimmune disease. In community practice, patients are older and more medically complex. We spend a surprising amount of time screening patients who ultimately can’t enroll because the criteria don’t reflect reality.
Protocol intensity adds another layer. Some trials ask a tremendous amount of patients and sites. Frequent visits, dense lab schedules, serial imaging, ECGs, biopsies, long questionnaires. In community clinics running full infusion schedules and busy clinics, that level of complexity strains staff and patients alike. Even highly motivated patients can struggle to keep up with the logistics.
Staffing. Community research teams are incredibly dedicated, but they run lean. Coordinators are screening, consenting, managing regulatory work, entering data, fielding sponsor queries, reporting adverse events, and preparing for monitoring visits often across multiple trials at once. When turnover happens, momentum slows quickly because replacing experience takes time.
Physician bandwidth is a big issue. Busy clinic days make it difficult to screen charts and walk every potentially eligible patient through a thoughtful consent discussion. Without embedded screening tools or dedicated research extenders, opportunities get missed.
The regulatory and data load continues to grow. eCRFs, deviation tracking, SAE reporting, monitoring queries, audits. It’s all necessary for safety and rigor, but it adds operational weight that smaller programs feel disproportionately.
Automated trial matching and AI-assisted screening should be helping identify eligible patients in real time, but adoption has been slow.
awareness remains a barrier. Patients often don’t know trials are available locally. Referring physicians may not know what’s open.
I can keep them coming but I thought I would hit the highlights.
Congratulations! There's been really interesting work in Europe for the last decade in clinical trial design because we've been so cost constrained. It's seemed to me to be incredibly interesting
Will be interested in following progress on this critical (but often overlooked topic). I have worked closely with those in clinical operations at a mid-size Biopharmaceutical company
Congrats. How will you determine the key limitations to address? I think several are in race conditions, meaning some problems have to be solved simultaneously to make a net difference. Three-way disintermediation among patient, physician and sponsor, with patient in the drivers seat and owning their own records, is pretty high on my list. As long as the process to determine the targets of intervention is solid, I am sure the outcome will be valuable!
Thanks! Agree that many trial cost drivers are interdependent, and I'm aiming to identify a package of reforms that can address cost/time in trials comprehensively. Also agree that patient-mediated data + consent is an important reform to explore. There's been lots of rhetoric, initiatives, and even APIs built, but I don't think it has tangibly shifted how research is done yet.
Couldn’t agree more. How do you intend to define the dependency graph for identifying the reforms? I have some work on this that might be shareable, checking now
Congratulations on launching this important work, Adam. If you ever want to bounce expert/relevant parties elicitation ideas, I'd be delighted to be a sounding board.
Hi Adam! Not sure if this aligns with what you're looking for, but I produced a documentary exploring the extreme consequences of FDA bureaucracy delaying important therapies for conditions like blindness and cancer, and how startup cities and free zones are emerging as powerful alternatives.
I’d love to hear your thoughts on it, and if it resonates, would be great to chat about potential collaboration.
You can watch it here: https://startupsociety.film
Thanks and congrats on the project.
I am happy to weigh in — we tried a similar initiative at ASCO RCF about 6 years ago but got grounded by Covid. We had FDA, industry and CROs in attendance.
From the community side, the pain points are pretty consistent.
A lot of it starts with eligibility. Many studies are still written for an idealized patient who rarely walks through our doors. Normal organ function, minimal comorbidities, no prior malignancies, limited brain involvement, no autoimmune disease. In community practice, patients are older and more medically complex. We spend a surprising amount of time screening patients who ultimately can’t enroll because the criteria don’t reflect reality.
Protocol intensity adds another layer. Some trials ask a tremendous amount of patients and sites. Frequent visits, dense lab schedules, serial imaging, ECGs, biopsies, long questionnaires. In community clinics running full infusion schedules and busy clinics, that level of complexity strains staff and patients alike. Even highly motivated patients can struggle to keep up with the logistics.
Staffing. Community research teams are incredibly dedicated, but they run lean. Coordinators are screening, consenting, managing regulatory work, entering data, fielding sponsor queries, reporting adverse events, and preparing for monitoring visits often across multiple trials at once. When turnover happens, momentum slows quickly because replacing experience takes time.
Physician bandwidth is a big issue. Busy clinic days make it difficult to screen charts and walk every potentially eligible patient through a thoughtful consent discussion. Without embedded screening tools or dedicated research extenders, opportunities get missed.
The regulatory and data load continues to grow. eCRFs, deviation tracking, SAE reporting, monitoring queries, audits. It’s all necessary for safety and rigor, but it adds operational weight that smaller programs feel disproportionately.
Automated trial matching and AI-assisted screening should be helping identify eligible patients in real time, but adoption has been slow.
awareness remains a barrier. Patients often don’t know trials are available locally. Referring physicians may not know what’s open.
I can keep them coming but I thought I would hit the highlights.
This is excellent Daniel. Do you have potential solutions to any of these, even in a highly idealized state?
Congratulations! There's been really interesting work in Europe for the last decade in clinical trial design because we've been so cost constrained. It's seemed to me to be incredibly interesting
Will be interested in following progress on this critical (but often overlooked topic). I have worked closely with those in clinical operations at a mid-size Biopharmaceutical company
Congrats. How will you determine the key limitations to address? I think several are in race conditions, meaning some problems have to be solved simultaneously to make a net difference. Three-way disintermediation among patient, physician and sponsor, with patient in the drivers seat and owning their own records, is pretty high on my list. As long as the process to determine the targets of intervention is solid, I am sure the outcome will be valuable!
Thanks! Agree that many trial cost drivers are interdependent, and I'm aiming to identify a package of reforms that can address cost/time in trials comprehensively. Also agree that patient-mediated data + consent is an important reform to explore. There's been lots of rhetoric, initiatives, and even APIs built, but I don't think it has tangibly shifted how research is done yet.
Couldn’t agree more. How do you intend to define the dependency graph for identifying the reforms? I have some work on this that might be shareable, checking now
Looking forward to your findings! Congrats on the grant
Adam, this is incredible. Congrats!!