The International Council for Harmonization (ICH) released an updated version of its guideline on general considerations for clinical trials, RAPS reports. ICH released the guideline, E8(R1), earlier this May for public consultation on the draft.
The revised guideline “identifies critical-to-quality factors…that can be adapted to different types of trials, address a broader range of trial designs and data sources, and provides an updated cross-referencing of other relevant ICH guidelines related to planning clinical studies.”¹ ICH puts forth four objectives for E8(R1), which include:
- “Describe internationally accepted principles and practices in the design and conduct of clinical studies that will facilitate acceptance of data and results by regulatory authorities
- Provide guidance on the consideration of quality in the design and conduct of clinical studies across the product lifecycle, including the identification during study planning of factors that are critical to the quality of the study, and the management of risks to those factors during study conduct
- Provide an overview of the types of clinical studies performed during the product lifecycle, and describe the aspects of those studies that support the determination of which quality factors are critical to ensuring the protection of study subjects, the integrity of the data, the reliability of results, and the ability of the studies to meet their objectives
- Provide a guide to the ICH efficacy documents to facilitate user’s access.”²
The guideline emphasizes that the likelihood that a clinical study will reliably answer the research questions posed in a manner that is meaningful for patients can be dramatically improved through prospective attention to the design of all components of the study protocol, procedures, and associated operational plans. Quality should “rely on good design and its execution rather than overreliance on retrospective document checking, monitoring, auditing, or inspection.”² The guideline goes on to define and describe critical to quality factors the approach to identify these factors, such as establishing a culture that supports open dialogue and engaging key stakeholders (e.g., patients and physicians) in the study design.
Future status updates on the ICH E8(R1) guideline as it progresses through the standard ICH process can be found here. If your team is in the process of planning a clinical trial for your drug, device, or diagnostic, Pearl Pathways can help you through every step of the process, from study design to enrolling the last patient and closing out the study. To learn more, read about our CRO services.