Introducing the Clinical Trials Efficiency Project
To make clinical trials faster and less costly, we need system-level reform
I’m excited to share that I am launching a new research project on systemic reforms to reduce the cost of clinical trials, funded by a grant from Coefficient Giving (formerly Open Philanthropy).
Over the past few months, I’ve been writing about how clinical trials became so expensive and inefficient, and why it’s so critical to reduce their costs. High clinical trial costs limit what we can study and limit the availability of new treatments for patients.
I believe that fixing this problem will require more than just new approaches and pilots; we need systemic reform: changes to the policy, infrastructure, incentives, and business models that underlie the industry. We also need to take collective action: We need to work together across the clinical trials and health policy community to make these reforms a reality.
Over the coming months, I’ll be working on doing just that. If you work in trials and have views on where the bottlenecks are to progress - or how we can fix them - please reach out to me - I would love to hear from you. You can message me on Substack or email me.
As we progress, I’ll be sharing what I learn on this Substack, so if you want to stay up to date on this effort, continue to follow me here.
Adam
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.
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.