All the activity of a clinical study culminates in the production of a clinical study report (CSR). More than a written summary of the results of a study, among its contents are the protocol followed during study conduct, lists of investigators, and the statistical output and methods. If printed, a CSR could number 1000 pages or more.
As mandated by Good Clinical Practice, the structure and content of a CSR is governed by the International Conference on Harmonisation’s Guideline E3 (ICH E3). Since 1996, writers have followed ICH E3 so closely that its section numbers have become the template for most CSRs. Say “Section 12,” for example, to a group of medical writers in the pharmaceutical industry, and they’ll know you’re talking about the section for reporting the safety results of a study.
Developed when the CSR was required to be filed with the Food and Drug Administration (FDA) on paper, ICH E3 is due for an update. Some requirements, such as those for reporting of adverse events, were ambiguous from the outset. Now the CSR structure must meet new requirements for wider reporting of clinical data. The FDA requires that clinical study data be reported on ClinicalTrials.gov within a year of study conclusion, and the European Medicines Agency (EMA) requires that CSRs themselves be made available.
The process of updating ICH E3 is now underway. A team of members of the European (EMWA) and the American (AMWA) Medical Writers associations, including writers, a biostatistician, and a clinical pharmacologist, are developing the Clarity and Openness in Reporting: E3-based (CORE) Reference. The CORE Reference is intended to serve as a “user manual” to complement ICH E3. The process is explained in detail in an article in EMWA’s official journal, Medical Writing.
Beginning in March 2015, the draft CORE Reference will be reviewed by stakeholders as diverse as regulators, the Drug Industry Association (DIA), the Clinical Data Interchange Standards Consortium (CDISC), and patient interest groups. This review is intended to garner broad acceptance for the CORE Reference among all parties involved in drug development.
The CORE Reference is expected to be available in mid-2016. The clearer standards for CSRs are expected to assist streamlined review of new drugs and easier access to clinical study data. The effort will even produce another document, a regulatory guidance for the clinical study protocol. Stay tuned for further developments!