Imposed registries within the European postmarketing surveillance system: Extended analysis and lessons learned for regulators
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.
|Persistent URL||dx.doi.org/10.1002/pds.4449, hdl.handle.net/1765/106389|
|Journal||Pharmacoepidemiology and Drug Safety: an international journal|
Păcurariu, A.C, Plueschke, K. (Kelly), Olmo, C.A. (Carla Alonso), & Kurz, X. (2018). Imposed registries within the European postmarketing surveillance system: Extended analysis and lessons learned for regulators. Pharmacoepidemiology and Drug Safety: an international journal. doi:10.1002/pds.4449