The FDA plans to reduce the number of required pivotal trials in Phase 3 clinical studies from two to one, aiming to streamline drug development. While this may benefit smaller biotech companies, the impact will vary by disease, as some conditions may still necessitate more trials to ensure safety and efficacy.

• FDA is shifting the default Phase 3 requirement from two pivotal trials to one, potentially cutting years and money off the $2.6 billion, 10-15 year drug development process.
• The impact will be uneven: urgent diseases like ALS could benefit from faster single-trial approval, while high-placebo-response conditions like pain may struggle to prove efficacy with just one study.
• Smaller biotechs with limited funding but multiple drugs in development stand to gain the most from reduced trial requirements.
• FDA plans to offset reduced pre-approval testing with continued postmarket surveillance and new tools like AI and real-world data to maintain safety and precision.

Biomedical progress in therapeutics has been hindered despite advances in basic science, a trend known as Eroom's Law. The Clinical Trial Abundance Project aims to enhance the efficiency and informativeness of clinical trials, arguing that learning from both successes and failures is crucial for developing new therapies, as exemplified by the evolution of CAR-T cell therapies.

• Inflation-adjusted drug development costs have doubled roughly every 9 years since the 1950s (Eroom's Law), even as basic science has advanced.
• Clinical trials shouldn't just validate existing hypotheses—they should function as an active discovery engine, with failures generating insights that improve subsequent trial designs.
• CAR-T therapy's eventual success (e.g., Kymriah's FDA approval via the ELIANA trial) came only after nearly two decades of iterative trial failures that progressively refined understanding of T cell responses.
• Making trials faster and more efficient isn't in tension with generating better drug hypotheses—the two goals are complementary and can reinforce each other in a positive feedback loop.