Randomised Clinical Trials. David Machin
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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).
3.18 Protocols
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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