New ICH Topic M11 CeSHarP

A new ICH topic was endorsed by the ICH Management Committee in November 2018: ICH M11 Clinical electronic Structured Harmonized Protocol (CeSHarP).

Current Status

The clinical protocol describes the processes and procedures directing the conduct and analysis of a clinical study. According to ICH, there is currently no internationally harmonized standard template for the format and content of the clinical protocol document, though. But only that would support consistency across sponsors and exchange of protocol information. Hence, there is a lack of harmonization. And this makes it more difficult and inefficient for regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders to review and assess clinical protocols. An international ICH guideline and template would therefore support consistency in the development of structured and unstructured protocol content. In addition, a technical specification will facilitate its electronic exchange.

In order for ICH to develop an internationally harmonized guideline, including a template, and a technical specification for the protocol, some issues have to be resolved first:

• Alignment and coordination with other ICH E-topics including (but not limited to) E3 (Structure and Content of Clinical Study Reports), E5 (Ethnic Factors in the Acceptability of Foreign Clinical Data), E6 (Good Clinical Practice, GCP), E8 (General Considerations for Clinical Trials), E9 (Statistical Principles for Clinical Trials), E11 (Clinical Investigation of Medicinal Products in the Pediatric Population) and E17 (General principles for planning and design of Multi-Regional Clinical Trials),
• The guideline, template, and technical specification will cover a broad range of study types (alignment with the ICH “GCP Renovation” initiative),
• The need for consistency must be balanced with flexibility to comply with local regulations and practices.

Background to the Proposal

The ICH M2 (Electronic Standards for the Transfer of Regulatory Information) Expert Working Group (EWG) identified the need for harmonized protocol structure and content. They further indicated the agreement on perceived value from a broadly adopted harmonized document organization supported by electronic content structured for exchange. This would increase efficiencies anticipated in most steps of study conduct (e.g., trial design, investigator on-boarding, study setup, study reporting, and review). The multidisciplinary EWG will combine the relevant clinical study protocol and electronic technical expertise (e.g. from the M2 EWG).

The Concept Paper supports a proposal for a new harmonized guideline. It would specify comprehensive clinical protocol organization with standardized content with both required and optional components. The new ICH M11 guideline will outline two main sets of harmonized approaches:

• a template to include identification of headers, common text and a set of data fields and terminologies which will be the basis for efficiencies in data exchange,
• a technical specification that uses an open, non-proprietary standard to enable electronic exchange of clinical protocol information.

The possible Step 2a/2b endorsement is currently expected for June 2020. More information can be found on the ICH Multidisciplinary Guidelines webpage.