Drug Registries and Approval of Drugs: Promises, Placebo, or a Real Success?
Clin Ther
; 40(5): 768-773, 2018 05.
Article
in En
| MEDLINE
| ID: mdl-29709456
ABSTRACT
PURPOSE:
As part of the approval process, regulatory authorities often require postauthorization studies that involve patient registries; it is unknown, however, whether such registry studies are adequately completed. We investigated whether registry studies for new drugs were performed as agreed at time of approval.METHODS:
This study reviewed protocols and follow-up reports for 73 registry studies that were proposed for 43 drugs approved by the Committee for Medicinal Products for Human Use in Europe in the period 2007 to 2010.RESULTS:
The data lock point of January 1, 2016, was taken to allow a 5-year follow-up period for each drug after approval. At that time, 2 studies (3%) in registries had been finalized, 19 registries (26%) had not enrolled any patients, and 52 studies (71%) were ongoing. The median enrollment was 31% (interquartile range [IQR], 6-104) of the required number of patients for 41 registry studies that had a predefined sample size, 30% (IQR, 2-101) for nonimposed registries, and 61% (IQR, 18-144) for imposed registries. IMPLICATIONS Enrollment of patients into postapproval registries is poor, although the results for imposed registries seem better. Currently, registries only have a limited impact on resolving gaps in the knowledge of a drug's benefits and risks at time of marketing authorization.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Registries
/
Drug Approval
Type of study:
Clinical_trials
Limits:
Humans
Country/Region as subject:
Europa
Language:
En
Journal:
Clin Ther
Year:
2018
Document type:
Article