The global guidance for the conduct of clinical trials is currently undergoing a major revision. As part of the worldwide consultation process, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is organising a public meeting to review its draft E8 (R1) Guideline ‘General Considerations for Clinical Trials’. EMA is encouraging its stakeholders to register for this meeting, which will be held on 31 October 2019 at the United States Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland, United States of America. Participants will be able to attend in person or via webcast.
The ICH E8 guideline sets out general scientific principles for the conduct, performance and control of clinical trials. In recent years, clinical trials have undergone a radical transformation with a wider range of both trial designs and data sources being used in drug development. Therefore, ICH initiated a revision of the E8 guideline to address all the aspects that were not covered by the current version of the guidance.
The revision aims to provide up-to-date and flexible guidance on clinical trial designs and data sources that can support regulatory and other health-policy decisions while ensuring that fundamental principles, such as the protection of clinical trial participants and assurance of data quality, are maintained. More info here.