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Background <p>The new European Regulation No. 536/2014 simplified and harmonized the procedures for the submission, assessment and monitoring of clinical drug trials across Europe, with the aim of improving efficiency and accelerating patient access to innovative therapies.</p> Purpose <p>This study aims to compare clinical trial submission and approval timelines at two Italian oncology centres, before and after the implementation of the European Regulation, to evaluate its impact.</p> Methods <p>We retrospectively analysed interval times of submission and approval of interventional clinical trials approved in two timeframes: 2021–2022 (pre-implementation of Regulation) and 2023–2024 (post-implementation). Key timepoints were recorded: submission, Ethics Committee approval, contract signing or local administrative authorization, and site activation. Time intervals were compared using the Wilcoxon test. Results: The analysis included 40 studies approved pre-implementation of European Regulation and 18 post-implementation. Under the new Regulation, a trend toward reduced time from approval to site activation was observed (median 75.5 vs. 106 days, p=0.078; mean difference -33.0 days, 95% CI -75.0; 2.0), with a significant time reduction from contract signing to activation (median 8 vs. 22.5 days, p=0.024; mean difference -10.0 days, 95% CI -23.0; -1.0). Overall time from submission to activation remained similar (168 vs. 169 days, p=0.5; mean difference 14.0 days, 95% CI −26.0 to 62.0), with a significant increase in the time from submission to approval (median 112 vs. 41 days, p=0.003; 73.7 days, 95% CI 37.0 to 101.0) under the new Regulation.</p> Conclusion <p>These results suggest a promising effect of EU Regulation 536/2014 on the final administrative stages, between contract signing and site activation. To confirm these issues, a longer observation period and a larger, multicentre dataset are needed, allowing stratification by study type and specific time intervals.</p>

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Impact of Regulation (EU) No. 536/2014 on clinical trial approval processes in two Italian oncology centers

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月2日

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  • Daniela Bencardino,
  • Fabiana Marchetti,
  • Cristina Mazzi,
  • Marianna Ferrari,
  • Francesca Garibaldi,
  • Giulia Ferrera,
  • Giulia Ponti,
  • Chiara Altavilla,
  • Laura Rossi,
  • Matteo Verzè,
  • Vanda Salutari,
  • Vincenzina Mora,
  • Elvia Malo,
  • Alessandro Inno,
  • Anna Fagotti,
  • Federico Giovanni Gobbi,
  • Stefania Gori

摘要

Background

The new European Regulation No. 536/2014 simplified and harmonized the procedures for the submission, assessment and monitoring of clinical drug trials across Europe, with the aim of improving efficiency and accelerating patient access to innovative therapies.

Purpose

This study aims to compare clinical trial submission and approval timelines at two Italian oncology centres, before and after the implementation of the European Regulation, to evaluate its impact.

Methods

We retrospectively analysed interval times of submission and approval of interventional clinical trials approved in two timeframes: 2021–2022 (pre-implementation of Regulation) and 2023–2024 (post-implementation). Key timepoints were recorded: submission, Ethics Committee approval, contract signing or local administrative authorization, and site activation. Time intervals were compared using the Wilcoxon test. Results: The analysis included 40 studies approved pre-implementation of European Regulation and 18 post-implementation. Under the new Regulation, a trend toward reduced time from approval to site activation was observed (median 75.5 vs. 106 days, p=0.078; mean difference -33.0 days, 95% CI -75.0; 2.0), with a significant time reduction from contract signing to activation (median 8 vs. 22.5 days, p=0.024; mean difference -10.0 days, 95% CI -23.0; -1.0). Overall time from submission to activation remained similar (168 vs. 169 days, p=0.5; mean difference 14.0 days, 95% CI −26.0 to 62.0), with a significant increase in the time from submission to approval (median 112 vs. 41 days, p=0.003; 73.7 days, 95% CI 37.0 to 101.0) under the new Regulation.

Conclusion

These results suggest a promising effect of EU Regulation 536/2014 on the final administrative stages, between contract signing and site activation. To confirm these issues, a longer observation period and a larger, multicentre dataset are needed, allowing stratification by study type and specific time intervals.