Making Prospective Registration of Observational Research a Reality

被引：79

作者：

Dal-Re, Rafael ^{[1
]}

Ioannidis, John P. ^{[2
,3
,4
,5
]}

Bracken, Michael B. ^{[6
,7
]}

Buffler, Patricia A. ^{[8
]}

Chan, An-Wen ^{[9
,10
]}

Franco, Eduardo L. ^{[11
,12
]}

La Vecchia, Carlo ^{[13
,14
]}

Weiderpass, Elisabete ^{[15
,16
,17
,18
]}

机构：

[1] Pasqual Maragall Fdn, Clin Res Program, E-08003 Barcelona, Spain

[2] Stanford Univ, Sch Med, Dept Med, Stanford Prevent Res Ctr, Stanford, CA 94305 USA

[3] Stanford Univ, Sch Med, Dept Hlth Res & Policy, Stanford, CA 94305 USA

[4] Stanford Univ, Sch Humanities & Sci, Dept Stat, Stanford, CA 94305 USA

[5] Meta Res Innovat Ctr Stanford METRICS, Stanford, CA USA

[6] Yale Univ, Sch Publ Hlth, Ctr Perinatal Pediat & Environm Epidemiol, New Haven, CT 06510 USA

[7] Yale Univ, Sch Med, Ctr Perinatal Pediat & Environm Epidemiol, New Haven, CT 06510 USA

[8] Univ Calif Berkeley, Sch Publ Hlth, Div Epidemiol, Berkeley, CA 94720 USA

[9] Univ Toronto, Womens Coll Hosp, Dept Med, Womens Coll,Res Inst, Toronto, ON M5G 1N8, Canada

[10] Univ Toronto, Inst Hlth Policy Management & Evaluat, Toronto, ON M5G 1N8, Canada

[11] McGill Univ, Dept Oncol, Montreal, PQ H2W 1S6, Canada

[12] McGill Univ, Dept Epidemiol & Biostat, Montreal, PQ H2W 1S6, Canada

[13] Univ Milan, Ist Ric Farmacol Mario Negri, Dept Epidemiol, I-20156 Milan, Italy

[14] Univ Milan, Dept Clin Sci & Community Hlth, I-20156 Milan, Italy

[15] Karolinska Inst, Dept Med Epidemiol & Biostat, SE-17177 Stockholm, Sweden

[16] Canc Registry Norway, Dept Res, NO-0304 Oslo, Norway

[17] Univ Tromso, Dept Community Med, Fac Hlth Sci, NO-9037 Tromso, Norway

[18] Samfundet Folkhalsan, FI-00014 Helsinki, Finland

来源：

SCIENCE TRANSLATIONAL MEDICINE | 2014年 / 6卷 / 224期

关键词：

CLINICAL-TRIAL REGISTRATION; CANCER-EPIDEMIOLOGY; PREREGISTRATION; STATEMENT; PROTOCOLS; HEALTH;

D O I：

10.1126/scitranslmed.3007513

中图分类号：

Q2 [细胞生物学];

学科分类号：

071009 ; 090102 ;

摘要：

The vast majority of health-related observational studies are not prospectively registered and the advantages of registration have not been fully appreciated. Nonetheless, international standards require approval of study protocols by an independent ethics committee before the study can begin. We suggest that there is an ethical and scientific imperative to publicly preregister key information from newly approved protocols, which should be required by funders. Ultimately, more complete information may be publicly available by disclosing protocols, analysis plans, data sets, and raw data.

引用

页数：4

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