Working Paper: NBER ID: w27882
Authors: Donald A. Berry; Scott Berry; Peter Hale; Leah Isakov; Andrew W. Lo; Kien Wei Siah; Chi Heem Wong
Abstract: We compare and contrast the expected duration and number of infections and deaths averted among several designs for clinical trials of COVID-19 vaccine candidates, including traditional randomized clinical trials and adaptive and human challenge trials. Using epidemiological models calibrated to the current pandemic, we simulate the time course of each clinical trial design for 504 unique combinations of parameters, allowing us to determine which trial design is most effective for a given scenario. A human challenge trial provides maximal net benefits—averting an additional 1.1M infections and 8,000 deaths in the U.S. compared to the next best clinical trial design—if its set-up time is short or the pandemic spreads slowly. In most of the other cases, an adaptive trial provides greater net benefits.
Keywords: COVID-19; vaccine trials; cost-benefit analysis; clinical trial design; human challenge trials
JEL Codes: C15; H12; H51; I1; I11
Edges that are evidenced by causal inference methods are in orange, and the rest are in light blue.
| Cause | Effect |
|---|---|
| HCT (Y10) | infections averted (I12) |
| HCT (Y10) | deaths averted (J17) |
| ARCT (Y60) | net benefits (J32) |
| HCT setup time (Y20) | infections averted (I12) |
| HCT setup time (Y20) | deaths averted (J17) |
| infection rates (I14) | outcomes of trial designs (C90) |
| setup times (Y20) | outcomes of trial designs (C90) |