The European Medicines Agency (EMA) has released an addendum to the ICH E6 (R2) guideline on good clinical practice (GCP) for a six-month public consultation. GCP is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that clinical-trial data are credible.
The current ICH E6 guideline provides a unified standard on GCP. It describes responsibilities and activities of sponsors, monitors, investigators and ethics committees.
Since the finalisation of this guideline in 1996, the scale, complexity and costs of clinical trials have increased. Developments in technology and risk management processes offer new opportunities to increase their efficiency by allowing sponsors to focus on relevant activities. With this in mind, the guideline has been amended to:
- encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure the protection of clinical trial participants, and data integrity
- update standards regarding electronic records and essential documents intended to increase the quality and efficacy of clinical trials
Updates have been made to several sections of the guideline. Stakeholders are invited to send their comments by 3 February 2016.
Author: Patrick Ginty