David Machin - Randomised Clinical Trials

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).

1 AHCC01 (1997). Randomised trial of tamoxifen versus placebo for the treatment of inoperable hepatocellular carcinoma. Clinical Trials and Epidemiology Research Unit, Singapore.

2 ENSG5 (1990). Comparison of high dose rapid schedule with conventional schedule chemotherapy for stage 4 neuroblastoma over the age of one year. UKCCSG, Leicester, UK.

3 COMPLIANCE (2015). Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: study protocol of a randomised controlled trial to evaluate the effect of short message service (SMS) reminder.

4 EXPEL (2016). Extensive peritoneal lavage after curative gastrectomy for gastric cancer (EXPEL): an international multicentre randomised controlled trial.

5 PRESSURE (2000). Pressure relieving support surfaces: a randomised evaluation. University of York, York and Northern and Yorkshire Clinical Trials Research Unit, Leeds, UK.

6 SQCP01 (2006). A randomised controlled trial comparing speech and growth outcomes between 2 different techniques and 2 different timings of surgery in the management of clefts of the secondary palate. KK Women’s & Children Hospital, Singapore and Chang Gung Memorial Hospital, Taiwan.

7 SQGL02 (1999). Brimonidine as a neuroprotective agent in acute angle closure glaucoma. Clinical Trials and Epidemiology Research Unit, Singapore.

8 SQNP01 (1997). Standard radiotherapy versus concurrent chemo‐radiotherapy followed by adjuvant chemotherapy for locally advanced (non‐metastatic) nasopharyngeal cancer. National Medical Research Council, Singapore.

9 SQOLP01 (1999). A randomised controlled trial to compare steroid with cyclosporine for the topical treatment of oral lichen planus. Clinical Trials and Epidemiology Research Unit, Singapore.

10 UKW3 (1992). Trial of preoperative chemotherapy in biopsy proven Wilms’ tumour versus immediate nephrectomy. UKCCSG, Leicester, UK.

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