To blind or not to blind first in human and exploratory clinical trials: Acceleration of development vs. risk of bias.

ABSTRACT: An IQ consortium working group (WG) conducted a survey across multiple biopharmaceutical companies to gain information about the level of blinding commonly utilized for early clinical development trials. The main objectives were: (1) to understand blinding practices between healthy volunteer (HV) and early explorative patient trials in all therapeutic areas except oncology where early clinical trials are commonly open-label; (2) to understand the rationale for blinding/unblinding practices; (3) to understand the groups and personnel involved in unblinding; and (4) strategic considerations around blinding/unblinding options in early clinical development trials-risk of bias vs. potential for acceleration. A survey containing 31 main questions with additional sub-clarifying questions was cond

SUBMITTER: Haertter S 

PROVIDER: S-EPMC8932719 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature