Table 3.

Requirements for changes in study conduct for progress-centered regulation of clinical research in lethal diseases

Current stateWhere we need to go
Amendments: approval often delays trialAmendments: minimal review and rapid approval for many specified types
Excessive documentationGreatly simplify documentation
 Little real value added Pragmatic postmarketing surveillance
 One of the major drivers of cost Investigator accreditation and then CME
 Redesign of entire documentation process
Study conduct: rigid adherence to protocolPI can verbally approve minor deviations to eligibility requirements
Minor variations permitted in treatment and testing schedules