共 16 条
[1]
Guidelines for good pharmacoepidemiology practice (GPP)
[J].
Andrews, Elizabeth B.
;
Arellano, Felix M.
;
Avorn, Jerry
;
Bortnichak, Edward A.
;
Chen, Robert
;
Dai, Wanju S.
;
de Abajo, Francisco J.
;
Dieck, Gretchen S.
;
de Vries, Corinne
;
Edlavitch, Stanley
;
Freiman, Joel
;
Hallas, Jesper
;
Jones, Judith K.
;
Koo, Linda
;
Kaufman, David W.
;
Kurz, Xavier
;
Lanes, Stephan
;
Mitchell, Allen A.
;
Moride, Yola
;
Nelson, Robert C.
;
Neutel, Ineke
;
Park, Byung-Joo
;
Perez-Gutthann, Susana
;
Reynolds, Robert
;
Sacks, Susan
;
Santanello, Nancy
;
Stang, Paul
;
Stergachis, Andrew
;
Strom, Brian L.
;
Stuermer, Til
;
Toh, Darren
;
Trontell, Anne
;
Walker, Alexander M.
;
Waller, Patrick
;
Watson, Douglas J.
;
West, Suzanne
;
Wilcock, Karen
;
Wise, Robert P.
.
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY,
2016, 25 (01)
:2-10

Andrews, Elizabeth B.
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Arellano, Felix M.
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Avorn, Jerry
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Bortnichak, Edward A.
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Chen, Robert
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Dai, Wanju S.
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

de Abajo, Francisco J.
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Dieck, Gretchen S.
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

de Vries, Corinne
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Edlavitch, Stanley
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Freiman, Joel
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Hallas, Jesper
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Jones, Judith K.
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Koo, Linda
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Kaufman, David W.
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Kurz, Xavier
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Lanes, Stephan
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Mitchell, Allen A.
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Moride, Yola
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Nelson, Robert C.
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Neutel, Ineke
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Park, Byung-Joo
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Perez-Gutthann, Susana
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Reynolds, Robert
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Sacks, Susan
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Santanello, Nancy
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Stang, Paul
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Stergachis, Andrew
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Strom, Brian L.
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Stuermer, Til
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Toh, Darren
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Trontell, Anne
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Walker, Alexander M.
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Waller, Patrick
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Watson, Douglas J.
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

West, Suzanne
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Wilcock, Karen
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark

Wise, Robert P.
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark Univ Southern Denmark, Dept Clin Pharmacol, JB Winslowsvej 19,2, DK-5000 Odense C, Denmark
[2]
[Anonymous], Cancer Moonshot
[3]
[Anonymous], 2018, Framework for FDA's Real-World Evidence Program
[4]
[Anonymous], 2023, Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products
[5]
[Anonymous], 2021, Data Standards for Drug and Biological Product Submissions Containing Real-World Data, Draft Guidance for Industry
[6]
[Anonymous], 2023, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products
[7]
[Anonymous], 2022, PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027
[8]
Exploring the ethical and regulatory issues in pragmatic clinical trials
[J].
Califf, Robert M.
;
Sugarman, Jeremy
.
CLINICAL TRIALS,
2015, 12 (05)
:436-441

Califf, Robert M.
论文数: 0 引用数: 0
h-index: 0
机构:
Duke Univ, Sch Med, Dept Med, Div Cardiol, Durham, NC 27706 USA
Duke Univ, Duke Translat Med Inst, Durham, NC USA Duke Univ, Sch Med, Dept Med, Div Cardiol, Durham, NC 27706 USA

Sugarman, Jeremy
论文数: 0 引用数: 0
h-index: 0
机构:
Johns Hopkins Univ, Berman Inst Bioeth, Baltimore, MD USA
Johns Hopkins Univ, Sch Med, Dept Med, Baltimore, MD 21205 USA Duke Univ, Sch Med, Dept Med, Div Cardiol, Durham, NC 27706 USA
[9]
Raising the Bar for Real-World Data in Oncology: Approaches to Quality Across Multiple Dimensions
[J].
Castellanos, Emily H.
;
Wittmershaus, Brett K.
;
Chandwani, Sheenu
.
JCO CLINICAL CANCER INFORMATICS,
2024, 8

Castellanos, Emily H.
论文数: 0 引用数: 0
h-index: 0
机构:
Flatiron Hlth Inc, 233 Spring St, New York, NY 10013 USA Flatiron Hlth Inc, 233 Spring St, New York, NY 10013 USA

Wittmershaus, Brett K.
论文数: 0 引用数: 0
h-index: 0
机构:
Flatiron Hlth Inc, 233 Spring St, New York, NY 10013 USA Flatiron Hlth Inc, 233 Spring St, New York, NY 10013 USA

Chandwani, Sheenu
论文数: 0 引用数: 0
h-index: 0
机构:
Flatiron Hlth Inc, 233 Spring St, New York, NY 10013 USA Flatiron Hlth Inc, 233 Spring St, New York, NY 10013 USA
[10]
New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)
[J].
Eisenhauer, E. A.
;
Therasse, P.
;
Bogaerts, J.
;
Schwartz, L. H.
;
Sargent, D.
;
Ford, R.
;
Dancey, J.
;
Arbuck, S.
;
Gwyther, S.
;
Mooney, M.
;
Rubinstein, L.
;
Shankar, L.
;
Dodd, L.
;
Kaplan, R.
;
Lacombe, D.
;
Verweij, J.
.
EUROPEAN JOURNAL OF CANCER,
2009, 45 (02)
:228-247

Eisenhauer, E. A.
论文数: 0 引用数: 0
h-index: 0
机构:
Queens Univ, Natl Canc Inst Canada, Clin Trials Grp, Kingston, ON, Canada Queens Univ, Natl Canc Inst Canada, Clin Trials Grp, Kingston, ON, Canada

Therasse, P.
论文数: 0 引用数: 0
h-index: 0
机构:
GlaxoSmithKline Biol, Rixensart, Belgium Queens Univ, Natl Canc Inst Canada, Clin Trials Grp, Kingston, ON, Canada

Bogaerts, J.
论文数: 0 引用数: 0
h-index: 0
机构:
European Org Res Treatment Canc, Ctr Data, Brussels, Belgium Queens Univ, Natl Canc Inst Canada, Clin Trials Grp, Kingston, ON, Canada

Schwartz, L. H.
论文数: 0 引用数: 0
h-index: 0
机构:
Mem Sloan Kettering Canc Ctr, New York, NY 10021 USA Queens Univ, Natl Canc Inst Canada, Clin Trials Grp, Kingston, ON, Canada

Sargent, D.
论文数: 0 引用数: 0
h-index: 0
机构:
Mayo Clin, Rochester, MN USA Queens Univ, Natl Canc Inst Canada, Clin Trials Grp, Kingston, ON, Canada

Ford, R.
论文数: 0 引用数: 0
h-index: 0
机构:
RadPharm, Princeton, NJ USA Queens Univ, Natl Canc Inst Canada, Clin Trials Grp, Kingston, ON, Canada

Dancey, J.
论文数: 0 引用数: 0
h-index: 0
机构:
NCI, Div Canc Treatment & Diag, Bethesda, MD 20892 USA Queens Univ, Natl Canc Inst Canada, Clin Trials Grp, Kingston, ON, Canada

Arbuck, S.
论文数: 0 引用数: 0
h-index: 0
机构:
Schering Plough Corp, Kenilworth, NJ 07033 USA Queens Univ, Natl Canc Inst Canada, Clin Trials Grp, Kingston, ON, Canada

Gwyther, S.
论文数: 0 引用数: 0
h-index: 0
机构:
E Surrey Hosp, Surrey, England Queens Univ, Natl Canc Inst Canada, Clin Trials Grp, Kingston, ON, Canada

Mooney, M.
论文数: 0 引用数: 0
h-index: 0
机构:
NCI, Div Canc Treatment & Diag, Bethesda, MD 20892 USA Queens Univ, Natl Canc Inst Canada, Clin Trials Grp, Kingston, ON, Canada

Rubinstein, L.
论文数: 0 引用数: 0
h-index: 0
机构:
NCI, Div Canc Treatment & Diag, Bethesda, MD 20892 USA Queens Univ, Natl Canc Inst Canada, Clin Trials Grp, Kingston, ON, Canada

Shankar, L.
论文数: 0 引用数: 0
h-index: 0
机构:
NCI, Div Canc Treatment & Diag, Bethesda, MD 20892 USA Queens Univ, Natl Canc Inst Canada, Clin Trials Grp, Kingston, ON, Canada

Dodd, L.
论文数: 0 引用数: 0
h-index: 0
机构:
NCI, Div Canc Treatment & Diag, Bethesda, MD 20892 USA Queens Univ, Natl Canc Inst Canada, Clin Trials Grp, Kingston, ON, Canada

Kaplan, R.
论文数: 0 引用数: 0
h-index: 0
机构:
Natl Canc Res Network, Leeds, W Yorkshire, England Queens Univ, Natl Canc Inst Canada, Clin Trials Grp, Kingston, ON, Canada

Lacombe, D.
论文数: 0 引用数: 0
h-index: 0
机构:
European Org Res Treatment Canc, Ctr Data, Brussels, Belgium Queens Univ, Natl Canc Inst Canada, Clin Trials Grp, Kingston, ON, Canada

Verweij, J.
论文数: 0 引用数: 0
h-index: 0
机构:
Erasmus Univ, Med Ctr, Rotterdam, Netherlands Queens Univ, Natl Canc Inst Canada, Clin Trials Grp, Kingston, ON, Canada