Module 5 Presentations

18/07/2024

Blinding Issues

• Blinding or masking is an integral part of clinical trial design • It is intended to limit the occurrence of conscious and unconscious bias in the conduct and interpretation of a clinical trial • It is the deliberate disguising of the identity of the product in accordance with the instructions of the sponsor • The essential aim is to prevent identification of the treatments until all such opportunities for bias have passed • Blinding rules out the well known ‘placebo effect’ which induces positive effects in a subject • Blinding also rules out the ‘nocebo effect’ which creates harmful effects in a subject

The Organisation for Professionals in Regulatory Affairs

23

Trial Design Issues

Single Blind

Blinded Study

Open Study

Double Blind

The Organisation for Professionals in Regulatory Affairs

24

12