Project 2025/6: Reducing Clinical Trial Complexity and Costs May Support Clinical Study Feasibility and Reduce Early Terminations

What recent publications and reports are pointing to. Evidence and open questions.

Clinical trials are essential for evaluating the safety and efficacy of new therapies, but the operational and financial burden of modern trials has grown significantly over recent decades. Trials are becoming more complex, expensive, and difficult to execute. These often require elaborated protocol designs, extensive regulatory documentation, and multi-site coordination. All of which contribute to longer timelines and higher costs. Recent analyst commentary on the clinical trials industry highlights complexity as a core challenge limiting feasibility. https://www.clinicaltrialsarena.com/features/clinical-trials-challenges-expect-2025

At the same time, funding disruptions have had measurable impacts on clinical research feasibility. A study published in JAMA Internal Medicine reported that NIH grant terminations disrupted approximately 3.5 % of active federally funded clinical trials, affecting over 74,000 enrolled participants and resulting in significant lost funding. These kinds of funding cutbacks do not reflect scientific failure but rather resource constraints that force studies to halt or terminate early. https://www.ajmc.com/view/nih-grant-terminations-disrupt-1-in-30-clinical-trials-impacting-over-74-000-participants

Operational burden and complexity not only challenge sponsors financially but also increase the risk of failure for individual trials and patient safety. A broad literature review of why clinical trials fail identifies high operational and financial burden as one of the factors associated with trial discontinuation, alongside recruitment challenges and design issues. This evidence reinforces the idea that cost and complexity are practical constraints in trial implementation. https://pmc.ncbi.nlm.nih.gov/articles/PMC6092479/

In response to these challenges, researchers and industry groups have begun to develop tools and frameworks to measure and mitigate complexity. A 2025 methodological study introduced a protocol complexity tool that quantifies different aspects of a trial’s design (operational execution, regulatory burden, patient/site burden, etc.) and correlates complexity scores with key trial indicators such as site activation and recruitment timelines. The aim is to provide evidence-based simplification without compromising scientific or ethical standards. https://www.researchgate.net/publication/395032442_Development_of_a_protocol_complexity_tool_a_framework_designed_to_stimulate_discussion_and_simplify_study_design

Beyond individual tools, advocacy from researchers and consortia highlights broader systemic barriers, such as regulatory fragmentation and administrative burden, which can delay trial start-up and reduce feasibility, especially in multinational research contexts. For example, groups in the EU have called for regulatory alignment and reduced administrative complexity to support clinical research across member states, recognizing that procedural obstacles repeatedly delay studies and increase costs. https://eatris.eu/news/clinical-trial-community-seek-urgent-implementation-of-life-science-strategy-as-european-research-becomes-increasingly-endangered/ 

These strands of evidence do not claim that simplification alone will guarantee more lifesaving drugs, nor that reducing cost automatically improves scientific reliability, but they do support a conditional hypothesis: if a large share of current trial resources is consumed by procedural complexity and cost burden rather than core scientific evaluation, then reducing unnecessary complexity could make some studies more operationally feasible within existing budgets, possibly enabling a broader set of research questions to be pursued. https://zenodo.org/records/15651378 

Open question: Does reducing administrative and operational complexity without weakening scientific standards actually free up resources to support additional trials, and could that in turn accelerate meaningful clinical advances? This remains a continuing area of professional and methodological inquiry rather than a settled fact. Recent publications and tool development efforts suggest it is a practical, evidence-informed question worth exploring.