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.
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.
Authors: Patricia McGettigan; Carla Alonso Olmo; Kelly Plueschke; Mireia Castillon; Daniel Zondag; Priya Bahri; Xavier Kurz; Peter G M Mol Journal: Drug Saf Date: 2019-12 Impact factor: 5.606
Authors: Patricia McGettigan; Carla Alonso Olmo; Kelly Plueschke; Mireia Castillon; Daniel Nogueras Zondag; Priya Bahri; Xavier Kurz; Peter G M Mol Journal: Drug Saf Date: 2019-11 Impact factor: 5.606
Authors: Jane Moseley; Spiros Vamvakas; Michael Berntgen; Alison Cave; Xavier Kurz; Peter Arlett; Virginia Acha; Simon Bennett; Catherine Cohet; Solange Corriol-Rohou; Emma Du Four; Christelle Lamoril; Anja Langeneckert; Maren Koban; Muriel Pasté; Susan Sandler; Karin Van Baelen; Agnese Cangini; Sonia García; Mercè Obach; Emmanuel Gimenez Garcia; Leonor Varela Lema; Hanna-Mari Jauhonen; Piia Rannanheimo; Deborah Morrison; Marc Van De Casteele; Anna Strömgren; Anders Viberg; Amr Makady; Chantal Guilhaume Journal: Br J Clin Pharmacol Date: 2020-04-24 Impact factor: 4.335
Authors: Carla J Jonker; Sieta T de Vries; H Marijke van den Berg; Patricia McGettigan; Arno W Hoes; Peter G M Mol Journal: Drug Saf Date: 2021-06-06 Impact factor: 5.606