Guidelines_for_phase_1_clinical_trials_2012.pdf

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1、Guidelinesforphase1clinicaltrials2012editionForewordThedevelopmentofnewandbettermedicinesisvitalforthepublichealth.Akeystepinmedicinesdevelopmentisthetransitionfromthelaboratorytothehumansubjectinaphase1clinicaltrial,whenpotentialnewmedicinesaregiventohumansforthefirsttime.Phase1isthegatew

2、aybetweenscientificresearchandclinicalmedicine.Thephase1trialfallswithintherealmofexperimentalscience,andrequiresarangeofskillsandexpertiseofthehigheststandard.Confidenceintheresultsdependsupontheclarityandunderstandingofthequestionsasked,anduponthequalityofthetrialdesignedtoanswerthem.How

3、ever,thesafetyandwell-beingofthesubjects–whethertheybehealthyindividualsorpatients–mustalwayshavepriority.Thetranslationofadvancesinthebiologicalsciencesintohealthbenefits,viathedevelopmentofnewmedicines,islikelytooccuratanincreasingpaceinthecomingyears.Newmedicineswillbebasedonprogressive

4、lyrefinedbiologicalandbiochemicalinsights.Theremaybenopriorexperienceinhumansofmanyofthenewtypesofmedicinethatadvancesinmolecularpharmacologyshouldyield.Thechallengesforphase1trialsinclude:findingmethodstoassessthepotencyandeffectivenessofthesenewmedicines;sharingofsafetyinformation;calcul

5、ationofthestartingdose;designofdose-escalationprotocols;and,intheinterestsofthewell-beingandsafetyofthesubjects,ever-vigilantattentiontoriskreductionandriskmanagementintheconductofthetrial.This2012editionoftheABPIGuidelinesforPhase1ClinicalTrialsissciencebased,andisaremarkablythoroughandno

6、tablyclearcompilationofupdatedinformationandguidanceonbestpractice.Itcoversallofthekeypoints,andwarrantsclosereadingandfrequentreferencebythoseinvolvedinthedevelopment,investigationandregulationofnewmedicines.Asweenteraneraofhighexpectationintheprovisionofmuch-neededinnovativemedicines,the

7、ABPIistobecommendedonthetimelyproductionofprofessionalguidancethatwillunderpinthesafeandeffectiveconductoffuturephase1trials.SirGordonDuffFloreyProfessorofMolecularMedicine,UniversityofSheffieldChairman,UKCommissiononHumanMedicines1PrefaceThefirsteditionofthes