Bridging blinded and unblinded analysis for ongoing safety monitoring and evaluation.
Contemp Clin Trials
; 83: 81-87, 2019 08.
Article
in En
| MEDLINE
| ID: mdl-31260790
ABSTRACT
In order to better characterize the safety profile of investigational new drugs (INDs) during clinical development, more interest and attention have been paid to ongoing safety monitoring and evaluation. The 2015 US FDA IND safety reporting draft guidance compels sponsors to periodically evaluate unblinded safety data. However, maintaining the trial blind is necessary to avoid jeopardizing the validity of study findings. In this article, we propose an innovative new approach which includes analyzing both blinded and unblinded data. The proposed two-stage framework incorporates periodic analyses of blinded safety data to detect and flag adverse events that may have potential risk elevation related to experimental treatment, as well as planned unblinded analyses to quantify associations between the drug and adverse events, and to determine thresholds for referring adverse events for medical review and safety reporting.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Drugs, Investigational
/
Randomized Controlled Trials as Topic
/
Double-Blind Method
/
Drug Approval
/
Drug-Related Side Effects and Adverse Reactions
Type of study:
Clinical_trials
/
Guideline
Limits:
Humans
Language:
En
Journal:
Contemp Clin Trials
Journal subject:
MEDICINA
/
TERAPEUTICA
Year:
2019
Type:
Article