关于药物临床试验方案中纳入、排除标准的若干思考

ChinJClinPharmacol99Vol.33No.2January2017SerialNo.232、Someopinionofinclusionandexclusioncriteriainthedrugclin[e-mail]anzhouGeneralHospitalofLanzhouCommandLanzhou730050China2．InstituteofClinicalPharmacologyFirstHospitalPekingUniversityBeijing100034China、。、、。72、、。。DOI10.13699/j.cnki.1001－6821.2017.02.001Ｒ97A1001－6821201702－0099－03AbstractTherehavenounifiedstandardsforinclusionandexclusioncriteriaofthedrugclinicaltrialprotocalinChinawhichmakestheinclu-sionandexclusioncriteriaindrugclinicaltrialprotocalisnotsuchscien-tificandrigoroussothattherehavesomedifficultforresearchersinchoosingtherightsubjects.Inthisarticlewehavesummarizeandcon-cludetheinclusionandexclusioncriteriaof72trialprotocalmeanwhilewereferencesomeinternationalmulticentertrialprotocal.Thenweputforwardourideasandsuggestionsforwhichitemsshouldbewrittenintoinclusioncriteriaorexclusioncriteriaandwhensignedinformedcon-sent.Ingeneralwethinktheinclusioncriteriashouldbethebasiccon-ditionswhenwedecidewhichonecouldtakepartinthetrialandexclu-sioncriteriaisalsoshouldbemeettheinclusioncriteriaotherwisethatcontainotherspecialconditionwhichdosenotmeettheexperimentcondi-tion.Insummaryinclusioncriteriashouldjustcontainsmaindiagnosisandotheraspectsshouldbewritteninexclusioncriteria.Keywordsdrugclinicaltrialinclusioncriteriaexclusioncriteriainformedconsent、、、。《》31、《》2、10033220171232、。1、3－5“”“”。。、。2、72、、1。7262106516633、6、7、48、156128571。、、。、。、、、、、。。3“”、“”、。1、72、Table1Concludeandsummarizetheinclusionandexclusioncriteriaof72drugclinicaltrialprojects/6201065165610/、//74815/6336/2011645861310＊＊/18283/＊＊23400612、/115378571/1311＊＊/17100400ChinJClinPharmacol101Vol.33No.2January2017SerialNo.2321“”212“”。、、。1。4、、。“”“、、”“、”。“、、”“、”6。。5、。72、、、、、。。“”、。。、“”1、。。1．3EB/OL．2003－08－062016－12－01．http//．sda．gov．cn/WS01/CL0053/24473．html．2．EB/OL．2007－07－102016－12－01．http//．sda．gov．cn/WS01/CL0053/24529．html．3．GCPJ．2014308746－749．4．J．2008246561－563．5．J．2010269707－710．6．J．2016328681－683．