Implementation of the ICH E6(R3) Guideline for Good Clinical Practice:an opportunity to decentralize and democratize clinical research in Peru
DOI:
https://doi.org/10.37711/rpcs.2025.7.3.7Keywords:
GCP, Ethics, Good Clinical Practice, R3Abstract
The letter discusses how the new ICH E6(R3) guideline can help improve clinical research in Peru. It highlights that its implementation would allow the development of decentralized clinical trials, making it easier for more people to participate from different locations. This represents an opportunity to make research more inclusive, accessible, and better adapted to the country’s reality.
Downloads
References
1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Guideline. Guideline for Good Clinical Practice [Internet]. Geneva: ICH; 6 de junio de 2025 [Consultado el 17 de junio del 2025]. Disponible en: https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf
2. Vayena E, Blasimme A, Sugarman J. Ensayos clínicos descentralizados: oportunidades y desafíos éticos. Lancet Digit Health [Internet]. 2023 [Consultado el 17 de junio del 2025];23(6):43-51. doi: 10.1016/S2589-7500(23)00052-3
3. Jean-Louis G. Seixas AA. The value of decentralized clinical trials: Inclusion, accessibility, and innovation. Science [Internet]. 2024 [Consultado el 17 de junio del 2025];385(6711):eadq4994. doi: 10.1126/science.adq4994
4. Heads of Medicines Agencies. Recommendation paper on decentralised elements in clinical trials [Internet]. 2022 [Consultado el 10 de junio del 2025]. Disponible en: https://health.ec.europa.eu/system/fles/2023-03/mp_decentralisedelements_clinical-trials_rec_en.pdf
5. Kaye J. Whitley EA. Lund D. Morrison M. Teare H. Melham K. Dynamic consent: a patient interface for twenty-first century research networks. Eur J Hum Genet. [Internet]. 2015 [Consultado el 10 de junio del 2025];23(2):141-6. doi: 10.1038/ejhg.2014.71
6. Heads of Medicines Agencies. Guideline on computerized systems and electronic data in clinical trials [Internet]. 2023 [Consultado el 16 de junio del 2025]. Disponible en: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-computerised-systems-electronic-data-clinicaltrials_en.pdf
7. Ponce de León Sierra J, Merma-Pillaca A. Transformación digital en el sector salud peruano: retos y avances recientes. Rev Panam Salud Publica [Internet]. 2024 [Consultado el 10 de junio del 2025];48:e138. doi: 10.26633/RPSP.2024.138
8. Dai H, Young P, Durant T, Gong G, Kang M, Krumholz HM, et al. TrialChain: A Blockchain-Based Platform to Validate Data Integrity in Large, Biomedical Research Studies [Internet]. 2018. [Consultado el 10 de junio de 2025]. Disponible en: https://arxiv.org/abs/1807.03662
9. Bhatt A. The revamped Good Clinical Practice E6(R3) guideline: Profound changes in principles and practice! Perspect Clin Res.
[Internet]. 2023 [Consultado el 10 de junio de 2025];14(4):167- 71. doi: 10.4103/picr.picr_184_23
10. Reglamento de ensayos clínicos. Decreto Supremo N.° 021-2017/AS (30 de junio de 2017). Disponible en: https://www.digemid.minsa.gob.pe/webDigemid/normas-legales/2017/decreto-supremo-n-021-2017-sa/

Downloads
Published
Issue
Section
License
Copyright (c) 2025 Heydee Lisbet Diaz Martinez

This work is licensed under a Creative Commons Attribution 4.0 International License.