When can real-world data generate real-world evidence?

被引：6

作者：

Rahman, Motiur ^{[1
]}

Dal Pan, Gerald ^{[2
]}

Stein, Peter ^{[3
]}

Levenson, Mark ^{[4
]}

Kraus, Stefanie ^{[5
]}

Chakravarty, Aloka ^{[6
]}

Rivera, Donna R. ^{[7
]}

Forshee, Richard ^{[8
]}

Concato, John ^{[1
,9
,10
]}

机构：

[1] US FDA, Off Med Policy, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[2] US FDA, Off Surveillance & Epidemiol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[3] US FDA, Off New Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[4] US FDA, Off Biostat, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[5] US FDA, Off Regulatory Policy, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[6] US FDA, Off Commissioner, Silver Spring, MD USA

[7] US FDA, Oncol Ctr Excellence, Silver Spring, MD USA

[8] US FDA, Off Biostat & Pharmacovigilance, Ctr Biol Evaluat & Res, Silver Spring, MD USA

[9] Yale Univ, Sch Med, Dept Med, New Haven, CT USA

[10] 10903 New Hampshire Ave, Silver Spring, MD 20993 USA

来源：

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY | 2024年 / 33卷 / 01期

关键词：

biologics; cures act; drugs; real-world data; real-world evidence; study design;

D O I：

10.1002/pds.5715

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

引用

页数：4

共 50 条

[1] Real-world study: from real-world data to real-world evidence
Wen, Yi
[J]. TRANSLATIONAL BREAST CANCER RESEARCH, 2020, 1
[2] Translating real-world evidence/real-world data
Ravenstijn, Paulien
[J]. CTS-CLINICAL AND TRANSLATIONAL SCIENCE, 2024, 17 (05):
[3] Editorial: Real-world data and real-world evidence in lung cancer
Gristina, Valerio
Eze, Chukwuka
[J]. FRONTIERS IN ONCOLOGY, 2024, 14
[4] Data Science Methods for Real-World Evidence Generation in Real-World Data
Liu, Fang
[J]. ANNUAL REVIEW OF BIOMEDICAL DATA SCIENCE, 2024, 7 : 201 - 224
[5] Editorial: Real-world data and real-world evidence in hematologic malignancies
Malagola, Michele
Ohgami, Robert
Greco, Raffaella
[J]. FRONTIERS IN ONCOLOGY, 2023, 13
[6] Real-World Battles with Real-World Data
Brown, Jeffrey
Bate, Andrew
Platt, Robert
Raebel, Marsha
Sauer, Brian
Trifiro, Gianluca
[J]. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2017, 26 : 254 - 255
[7] Assessing Real-World Data Quality: The Application of Patient Registry Quality Criteria to Real-World Data and Real-World Evidence
Gliklich, Richard E.
Leavy, Michelle B.
[J]. THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2020, 54 (02) : 303 - 307
[8] Assessing Real-World Data Quality: The Application of Patient Registry Quality Criteria to Real-World Data and Real-World Evidence
Richard E. Gliklich
Michelle B. Leavy
[J]. Therapeutic Innovation & Regulatory Science, 2020, 54 : 303 - 307
[9] Turning real-world data into real-world evidence: some practical guidance
Schneeweiss, Sebastian
[J]. PRAVENTION UND GESUNDHEITSFORDERUNG, 2023,
[10] Advancing regulatory science through real-world data and real-world evidence
Cure, Pablo
Fessel, Joshua P.
Hartshorn, Christopher M.
Steele, Scott J.
[J]. JOURNAL OF CLINICAL AND TRANSLATIONAL SCIENCE, 2024, 8 (01)

← 1 2 3 4 5 →