FDA of­fers sta­tis­ti­cal guid­ance for tri­als im­pact­ed by Covid-19

The FDA on Wednes­day is­sued im­me­di­ate­ly ef­fec­tive guid­ance of­fer­ing sta­tis­ti­cal ad­vice to clin­i­cal tri­al spon­sors with the aim of main­tain­ing tri­al in­tegri­ty and mit­i­gat­ing the ef­fects of Covid-19 pub­lic health emer­gency on clin­i­cal tri­als.

The new doc­u­ment fol­lows the agency’s guid­ance on the con­duct of clin­i­cal tri­als amid the pan­dem­ic, which has been up­dat­ed sev­er­al times to in­clude ad­di­tion­al ques­tions and an­swers since be­ing is­sued in March.

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