Table 1.

General changes required for progress-centered regulation of clinical research in lethal diseases

Current stateWhere we need to go
Safety/compliance-centered regulationProgress-centered regulation for lethal diseases
Long and costlyFast and inexpensive
Large studies, small gainsSmall studies, large gains
OversightOversight
 Same agencies for all indications Separate regulators for lethal versus nonlethal diseases
 Regulatory gridlock since multiple regulators Single regulator for research in lethal diseases
Contracts/intellectual property agreements: often time-consuming and complicatedStandardized, simple, rapid
Privacy laws excessively restrictiveRationalize privacy laws