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Imposed registries within the European postmarketing surveillance system: Extended analysis and lessons learned for regulators
Author(s) -
Pacurariu Alexandra,
Plueschke Kelly,
Olmo Carla Alonso,
Kurz Xavier
Publication year - 2018
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.4449
Subject(s) - postmarketing surveillance , medicine , pharmacoepidemiology , pharmacology , adverse effect , medical prescription
Purpose Building on previous research, we examined whether delayed study start and low patient accrual rates found in 31 postauthorization registry‐based studies requested by European Medicines Agency (EMA) are maintained after 2 additional years of follow‐up. Method The registries identified in the previous EMA study and the same methodology were used. The follow‐up was extended from June 2015 to November 2017. The information available for the following variables was updated: marketing authorization status, study and registry status, study end date, planned duration, number of patients planned to be enrolled, and actual patients enrolled. Data were collected from several nonpublic in‐house sources such as the study protocols, interim and final study reports, risk management plans, and periodic safety update reports. Results As of November 2017, 10 (32.2%) studies were finalized (vs. 9.7% as of June 2015), 14 (45.2%) were still ongoing (vs. 64.5%). Four of the ongoing studies had patients' accrual lower than 50%. Six of the finalized studies had a delayed completion, with a median delay of 3 years. As of November 2017, the median patients' accrual percentages were 24% for ongoing studies (vs. 8.5%) and 101% for finalized studies (vs. 24%). Conclusion Overall, the rate of recruitment and timely finalization were improved after 2 years of additional follow‐up but show that further work is needed to facilitate use of registry data for regulatory purposes, a work that has started via the EMA registry initiative.