An IQ consortium (IQ) 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 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 conducted. Sixteen large and mid-size pharmaceutical companies responded. Responses were aligned across functions within each participating company. Additional information was gathered at an AAPS webinar with polling options to roughly 550 registered attendees to evaluate the reason for the unblinding decisions.

The results revealed divergence across companies in the blinding approaches most commonly applied but with some study types, there were clearly favored options. Based on these results, the WG developed strategic considerations for first in human healthy volunteer trials and non-pivotal, explorative trials in patients. This mansucript should facilitate discussions among various clinical development functions, such as Clinical Pharmacology, Statistics, Clinical, Bioanalytics and Regulatory Functions. Such discussions on study design and operations are warranted to allow implementation of more flexible blinding approaches to accelerate data driven decisions in drug development and allow earlier access of patients to needful medicines.