Balancing Phase II and III Efficacy Trials

被引：0
|
作者：
Bobby W. Sandage
机构：
[1] Interneuron Pharmaceuticals,
[2] Inc.,undefined
来源：
Drug information journal : DIJ / Drug Information Association | 1998年 / 32卷 / 4期
关键词：
Efficacy trials; Phase II and III;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
This paper compares the traditional drug development pathways with an innovative method for combining objectives and study designs within one trial. Evidence is offered in support of combining Phase II and Phase III trials for certain diseases and drugs. Newer regulations and guidelines are encouraging drug developers to be efficient and creative in conducting clinical trials.
引用
收藏
页码：977 / 980
页数：3
相关论文
共 50 条
  • [41] Efficacy and safety of tofacitinib in patients with rheumatoid arthritis by previous treatment: post hoc analysis of phase II/III trials
    Tesser, John
    Gul, Ahmet
    Olech, Ewa
    Oelke, Kurt
    Lukic, Tatjana
    Kwok, Kenneth
    Ebrahim, Abbas
    [J]. ARTHRITIS RESEARCH & THERAPY, 2023, 25 (01)
  • [42] Efficacy, tolerability and management of raltitrexed (Tomudex™) monotherapy in patients with advanced colorectal cancer:: a review of phase II/III trials
    Cunningham, D
    Zalcberg, J
    Maroun, J
    James, R
    Clarke, S
    Maughan, TS
    Vincent, M
    Schulz, J
    Barón, MG
    Facchini, T
    [J]. EUROPEAN JOURNAL OF CANCER, 2002, 38 (04) : 478 - 486
  • [43] EFFICACY OF PEMAFIBRATE ON ATHEROGENIC DYSLIPIDEMIA: RESULTS OF A POOLED ANALYSIS OF PEMAFIBRATE PHASE II/III CLINICAL TRIALS COMPARED WITH PLACEBO
    Ishibashi, Shun
    Arai, Hidenori
    Yokote, Koutaro
    Araki, Eiichi
    Suganami, Hideki
    Yamashita, Shizuya
    [J]. ATHEROSCLEROSIS SUPPLEMENTS, 2018, 32 : 25 - 26
  • [44] Phase II and III clinical trials of toremifene for metastatic breast cancer
    Vogel, CL
    [J]. ONCOLOGY-NEW YORK, 1998, 12 (03): : 9 - 13
  • [45] Minimizing efficacy differences between phase II and III RCTs
    Strand, Vibeke
    [J]. NATURE REVIEWS RHEUMATOLOGY, 2020, 16 (07) : 359 - 360
  • [46] Sample size planning for phase II trials based on success probabilities for phase III
    Goette, Heiko
    Schueler, Armin
    Kirchner, Marietta
    Kieser, Meinhard
    [J]. PHARMACEUTICAL STATISTICS, 2015, 14 (06) : 515 - 524
  • [47] Minimizing efficacy differences between phase II and III RCTs
    Vibeke Strand
    [J]. Nature Reviews Rheumatology, 2020, 16 : 359 - 360
  • [48] Emerging drugs for hemophilia A: insights into phase II and III clinical trials
    Kizilocak, Hande
    Young, Guy
    [J]. EXPERT OPINION ON EMERGING DRUGS, 2021, 26 (04) : 337 - 350
  • [49] Hepatic profile analyses of tipranavir in Phase II and III clinical trials
    Mikl, Jaromir
    Sulkowski, Mark S.
    Benhamou, Yves
    Dieterich, Douglas
    Pol, Stanislas
    Rockstroh, Juergen
    Robinson, Patrick A.
    Ranga, Mithun
    Stern, Jerry O.
    [J]. BMC INFECTIOUS DISEASES, 2009, 9
  • [50] Current phase II and phase III clinical trials for pancreatic cancer - Referral resource
    Mooney, MM
    Schoenfeldt, M
    [J]. ONCOLOGY-NEW YORK, 2004, 18 (08): : 1008 - +
12345