Lesson: Blinding And Unblinding In Clinical Trials

Question 1

Blinding in clinical research

Answer 1

Refers to the concealment of treatment allocation from one or more clinical research staff, most commonly a randomized controlled trial (RCT)

Question 2

How do we avoid bias in clinical trials?

Answer 2

-Randomization of subjects
-Blinding of subjects as well as investigators
-monitoring of clinical trial
-checking original sources document
-slice data verification
-Clinical data management
-QC and QA procedures

Question 3

SOP for billing
Steps to fallow before the trial begins

Answer 3

-List all staff who have access to treatment codes
-list all events and situations that could reveal treatment codes to a blinded staff member
-identify all events that require a blinded person to learn the treatment codes. Planned events that could unblind a trial
-safety monitoring by a data monitoring committee identifies one patient or a group of participants that must be withdrawn from treatment
- execution or interpretation of planned interim analysis
-preparation of information for a meeting of the data monitoring committee
-analysis or interpretation of lab data, pk data or other information where the response of a patient clearly distinguish treatment form control patient

Question 4

SOP for blinding
During trial execution

Answer 4

-Document any occurrence of a staff who should be blinded during the trial, but learns the treatment assignment of one or more patient
-document any occurrence of a patient who learn their treatment.

Question 5

SOP for blinding
At the conclusion of the trial

Answer 5

Confirm that all activities that must be performed while blinded have been finished

Complete deliverable #3 “activities must be completed before the blind is broken “

Question 6

Types of unblinding

Answer 6

-Non-Emergency
-at the end of trial
-emergency unblinded
-unblinding for Interim analysis
-accidental unblinding