id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-004647-0fuy5tlp	Patson, Noel	Systematic review of statistical methods for safety data in malaria chemoprevention in pregnancy trials	2020-03-20		.txt	text/plain	5666	266	39	METHODS: The search included five databases (PubMed, Embase, Scopus, Malaria in Pregnancy Library and Cochrane Central Register of Controlled Trials) to identify original English articles reporting Phase III randomized controlled trials (RCTs) on anti-malarial drugs for malaria prevention in pregnancy published from January 2010 to July 2019. This review, therefore, aims at identifying applied statistical methods and their appropriateness in the analysis of safety data in anti-malarial drugs for malaria prevention during pregnancy clinical trials. This review sought to provide a detailed overview of the actual practice of the statistical analysis of safety data in the unique setting of drug trials for the preventions of malaria in pregnancy as reflected published literature. Advantageously, methods based on causal inference framework, such as mediation analysis [28] [29] [30] [31] could be adapted/extended to assess the influence of the AEs on non-adherence in RCTs. Despite about three-quarters of the trials reporting p-values after comparing safety outcomes by treatment arms, only about half of the reviewed trials adhered to International Harmonisation Conference Guideline E9 in reporting of confidence intervals in quantifying the safety effect size [3, 4] .	./cache/cord-004647-0fuy5tlp.txt	./txt/cord-004647-0fuy5tlp.txt