id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-348244-1py0k53e	Buyse, Marc	Central statistical monitoring of investigator-led clinical trials in oncology	2020-06-23		.txt	text/plain	4050	181	45	We describe the principles of central statistical monitoring, provide examples of its use, and argue that it could help drive down the cost of randomized clinical trials, especially investigator-led trials, whilst improving their quality. Yet, there is no evidence showing that extensive data monitoring has any major impact on the quality of clinical-trial data, and none of the randomized studies assessing more intensive versus less intensive monitoring has shown any difference in terms of clinically relevant treatment outcomes [18] [19] [20] [21] [22] . Both types of trials may benefit from central statistical monitoring of the data; industry-sponsored trials to target centers that are detected as having potential data quality issues, which may require an on-site audit, and investigatorled trials as the primary method for checking data quality. An evidence-based study of the cost for data monitoring in clinical trials A statistical approach to central monitoring of data quality in clinical trials	./cache/cord-348244-1py0k53e.txt	./txt/cord-348244-1py0k53e.txt