In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which...

Randomization is a key element in open-label, parallel group clinical trials to reduce selection bias and ensure that participant allocation is not influenced by investigators. Despite the absence of blinding in open-label studies, randomization maintains the validity and reliability of the results by evenly distributing confounding factors between groups.

GCP guidelines recommend randomization as a core element in clinical trial design to ensure unbiased allocation of participants.

"Randomization in parallel group trials helps minimize selection bias and ensures the comparability of intervention groups."

Objectives:

Maintain scientific rigor through randomization.

Minimize selection bias in clinical studies.