Lessons learned for data harmonization and integration from secondary use of randomized controlled trial (RCT) and realworld data in the context of a study to evaluate external comparator arm study results versus RCT results

被引:0
|
作者
Hoogendoorn, Wilhelmina E. [1 ]
Sanz, Hector [1 ]
Quinten, Chantal [2 ]
Largent, Joan [1 ]
Rippin, Gerd [1 ]
机构
[1] IQVIA, Durham, NC USA
[2] European Med Agcy, Amsterdam, Netherlands
关键词
D O I
暂无
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
564
引用
收藏
页码:262 / 262
页数:1
相关论文
共 9 条
  • [1] A methodology study to evaluate external comparator arm study results versus randomized controlled trial results: Multiple myeloma case study
    Hoogendoorn, Lisette
    Sanz, Hector
    Quinten, Chantal
    Pignatti, Francesco
    Largent, Joan
    Rippin, Gerd
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2022, 31 : 437 - 438
  • [2] A methodology study to evaluate external comparator arm study results versus randomized controlled trial results: Metastatic hormone-sensitive prostate cancer case study
    Hoogendoorn, Wilhelmina E.
    Sanz, Hector
    Quinten, Chantal
    Largent, Joan
    Rippin, Gerd
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2023, 32 : 62 - 62
  • [3] EFFECTS OF BENZODIAZEPINE AND OTHER HYPNOTIC USE ON EFFICACY RESULTS IN PLACEBO CONTROLLED ANTIPSYCHOTIC TRIALS: LESSONS LEARNED FROM THE NEWMEDS REPOSITORY OF RCT DATA FROM ASTRAZENECA, JANSSEN, ELI LILLY, LUNDBECK, AND PFIZER
    Rabinowitz, Jonathan
    Werbeloff, Nomi
    Kinon, Bruce
    Mandel, Francine
    Stauffer, Virginia
    Menard, Francois
    Jaeger, Judith
    Kapur, Shitij
    SCHIZOPHRENIA RESEARCH, 2012, 136 : S77 - S77
  • [4] FACTORS CONTRIBUTING TO ENTRUSTMENT DECISIONS IN EGD AND COLONOSCOPY AMONG GASTROENTEROLOGY (GI) TRAINEES: RESULTS FROM A CLUSTER RANDOMIZED CONTROLLED TRIAL (RCT) ON COMPETENCE IN EGD AND COLONOSCOPY - THE ENCOMPAS STUDY
    Han, Samuel
    Obuch, Joshua C.
    Keswani, Rajesh N.
    Patel, Swati
    Ezekwe, Ezenwanyi
    Simon, Violette C.
    Hall, Matt
    Carlin, Linda
    Ellert, Swan
    Ahmad, Asyia S.
    Pietrak, Stanley J.
    Lunsford, Tisha
    Morigeau, Kirsten J.
    Duloy, Anna
    Piper, Michael
    Cooley, David M.
    Kerman, David H.
    Goyal, Jatinder
    Shergill, Amandeep K.
    Kathpalia, Priya
    Lee, Robert H.
    Mittal, Mohit
    Di Palma, Jack
    Sonnier, William
    Early, Dayna
    Alghamdi, Saad A.
    Vignesh, Shivakumar
    Shapiro, Alan
    Broy, Charles
    Gaumnitz, Eric
    Austin, Kerstin
    Shah, Anand
    Wani, Sachin B.
    Menard-Katcher, Paul
    GASTROENTEROLOGY, 2019, 156 (06) : S952 - S952
  • [5] Prognostic stratification using the nomogram sarculator and its impact on study results in a randomized controlled trial (RCT) for localized soft tissue sarcomas (STS): A secondary analysis of the EORTC-STBSG 62931.
    Pasquali, Sandro
    Pizzamiglio, Sara
    Touati, Nathan
    Litiere, Saskia
    Marreaud, Sandrine
    Kasper, Bernd
    Gelderblom, Hans
    Stacchiotti, Silvia
    Verderio, Paolo
    Casali, Paolo Giovanni
    Woll, Penella
    Gronchi, Alessandro
    JOURNAL OF CLINICAL ONCOLOGY, 2018, 36 (15)
  • [6] A randomized controlled trial to evaluate laparoscopic versus open complete mesocolic excision (CME) for stage II, III colorectal cancer (CRC): First efficacy results from Japan Clinical Oncology Group Study JCOG0404.
    Inomata, Masafumi
    Katayama, Hiroshi
    Mizusawa, Junki
    Watanabe, Masahiko
    Sugihara, Kenichi
    Konishi, Fumio
    Yamamoto, Seiichiro
    Saito, Shuji
    Fujii, Shoichi
    Saida, Yoshihisa
    Hasegawa, Hirotoshi
    Etoh, Tsuyoshi
    Moriya, Yoshihiro
    Kitano, Seigo
    JOURNAL OF CLINICAL ONCOLOGY, 2015, 33 (03)
  • [7] A randomized controlled trial to evaluate laparoscopic versus open with Japanese D3 dissection for stage II,III colorectal cancer (CRC): First efficacy results from Japan Clinical Oncology Group Study JCOG0404
    Akagi, Tomonori
    Inomata, Masafumi
    Katayama, Hiroshi
    Mizusawa, Junki
    Yamaguchi, Takashi
    Masaki, Tadahiko
    Fukunaga, Yosuke
    Murata, Kohei
    Okajima, Masazumi
    Munakata, Yasuhiro
    Sato, Takeo
    Bandou, HIroyuki
    Yasui, Masayoshi
    Sekimoto, Mitsugu
    Watanabe, Masahiko
    Sugihara, Kenichi
    Konishi, Fumio
    Etoh, Tsuyoshi
    Shimada, Yasuhiro
    Kitano, Seigo
    JOURNAL OF CLINICAL ONCOLOGY, 2015, 33 (15)
  • [8] Azacitidine in Acute Myeloid Leukemia with >30% Bone Marrow Blasts and <15 G/L White Blood Cell Count: Results from the Austrian Azacitidine Registry of the AGMT Study Group Versus Randomized Controlled Phase III Clinical Trial Data
    Pleyer, Lisa
    Burgstaller, Sonja
    Stauder, Reinhard
    Girschikofsky, Michael
    Sill, Heinz
    Schlick, Konstantin
    Thaler, Josef
    Halter, Britta
    Machherndl-Spandl, Sigrid
    Zebisch, Armin
    Pichler, Angelika
    Pfeilstoecker, Michael
    Autzinger, Eva-Maria
    Lang, Alois
    Geissler, Klaus
    Voskova, Daniela
    Geissler, Dietmar
    Sperr, Wolfgang R.
    Hojas, Sabine
    Rogulj, Inga Mandac
    Andel, Johannes
    Greil, Richard
    BLOOD, 2015, 126 (23)
  • [9] RESULTS OF HRQOL DATA FROM PALETTE: A RANDOMIZED DOUBLE BLIND PHASE III TRIAL OF PAZOPANIB VERSUS PLACEBO IN METASTATIC SOFT TISSUE SARCOMA (STS) PATIENTS. AN EORTC STBSG GLOBAL NETWORK STUDY (EORTC 62072)
    Coens, C.
    van der Graaf, W. T. A.
    Blay, J.
    Chawla, S. P.
    Kim, D.
    Sanfilippo, R.
    Manson, S.
    Ouali, M.
    Marreaud, S.
    Bottomley, A.
    ANNALS OF ONCOLOGY, 2012, 23 : 483 - 483