Clinical trials and the regulation of drugs

Paul Leber Introduction

Whyandhowlhe United States, Federal Government., .came, to...exe.rcis,e ..control., over, thequality., ofthe

Securing., .theaims, .ofreguiation

Principles., iof..iciliiniicali, .tria.l.„d,es.i„gn, ..c.on.d„u.c,t,„an.d.., interpretation Th£.„ch,oi£e.., of. . control. , conditions Assay., .sensitivity

Problems.of, bias

What, .is ..'substantial: evidence?

Approval., as,, a,..risk—benefit., determination

The.., future ..of., c.o.nt.roile,d...c,lini,cal .regulatory., trials C.h.apte.r.,Refe.rence.s

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