Safety assessment in radomized controlled clinical trials / 中华男科学杂志

ABSTRACT

<p><b>OBJECTIVE</b>To introduce some methods of safety assessment in randomized controlled clinical trials.</p><p><b>METHODS</b>Recent advances and current parctice in normalized safety assessment were reviewed and relevant data analyzed. RESTULTS The statistical issues including analysis and presentation of adverse events data and laboratory data were involved and summed up.</p><p><b>CONCLUSION</b>With the progressive development of randomized controlled clinical trials in China, the methods introduced in this paper are sure to prove of consultative value for the safety assessment.</p>