Drug­mak­ers seek tweaks to FDA guid­ance on mea­sur­ing de­vel­op­ment in pe­di­atric tri­als

Bris­tol My­ers Squibb, No­var­tis, As­traZeneca and in­dus­try group BIO are all seek­ing al­ter­ations to the FDA’s re­cent draft guid­ance to help spon­sors mea­sure the growth and eval­u­ate the pu­ber­tal de­vel­op­ment in pe­di­atric clin­i­cal tri­als.

The 10-page draft guid­ance, re­leased last Oc­to­ber, ex­plains how if a drug could have an im­pact on the growth or pu­ber­tal de­vel­op­ment of par­tic­i­pants in a tri­al, such tri­als should in­clude ac­cu­rate, se­r­i­al mea­sure­ments and record­ings of growth pa­ra­me­ters. The FDA calls on and ex­plains how spon­sors should look in­to par­tic­i­pants’ changes in age, length/height, weight, head cir­cum­fer­ence in some cir­cum­stances, and more.

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