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>