Did pre-registration requirements reduce the share of clinical trials showing benefits?
Core argument: Large NHLBI clinical trials showed significant benefits in 57% of studies before 2000 but only 8% after 2000, a statistically significant shift (χ2=12.2, df=1, p=0.0005).
The proportion of NHLBI [National Heart, Lung, and Blood Institute] clinical trials showing significant benefits has decreased significantly over time, with 57% of studies before 2000 showing benefits compared to only 8% after 2000. This shift is statistically significant (χ2=12.2, df=1, p=0.0005) and coincides with the introduction of pre-registration in clinicaltrials.gov, which emphasizes transparent reporting standards. The trend toward null findings is not influenced by industry co-sponsorship or the type of comparator used in trials. The decline in positive results post-2000 suggests that stricter reporting and outcome declaration requirements may have contributed to this trend, highlighting a shift in the landscape of clinical research and its implications for future medical and economic policies.

