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As we have indicated GCP, set out in ICH E6 (R2) (2016), will dictate in full the items that are mandatory for such a protocol. Similarly, the SPIRIT 2013 statement provides recommendations for a minimum set of scientific, ethical and administrative elements that should be addressed in a clinical trial protocol. It is particularly important, and especially for clinical trials seeking formal registration of a new product, that investigators check local, national and even international requirements for what has to be included in the protocol itself. The definition of what is a ‘protocol’ given by Day (2007) and slightly amended in our Glossary includes the phrase ‘important details’ so it is imperative to check the current status of exactly what current versions of the guidelines are suggesting as they are continually changing. For example, the ICH E6 (R2) (2016, Section 6) specifies for protocols sections on: Direct access to source data/documents; Quality control and quality assurance; Data handling and record keeping: Financing and insurance which we do not include in Figure 3.1. In this document Section 8 also includes: Before the clinical phase of the trial commences; During the conduct of the trial; After completion or termination of the trial. Although these sections may be more appropriate to trials for products seeking regulatory approval, they contain many items pertinent in a wider context. Day (2007) in Appendix 1 of his dictionary lists 18 ICH ‘Efficacy’ Guidelines. The latest updates of these can be obtained from the ICH official website: http://www.ich.org.

1 ICH E6 (R2) (2016). Guideline for Good Clinical Practice. EMA/CHMP/ICH/135/1995.

2 ICH E9 (R1) (2018). Statistical Principles for Clinical Trials. CPMP/ICH/363/96.

3 SPIRIT 2013 Statement (2013). Defining Standard Protocol Items for Clinical Trials. http://www.spirit‐statement.org (see Chan, Tetzlaff, Gøtzsche, et al., 2013).