Interpretation of subgroup analyses in medical device clinical trials

被引:0
|
作者
Scott, PE [1 ]
Campbell, G [1 ]
机构
[1] US FDA, Div Biostat, Off Surveillance & Biometr, Ctr Devices & Radiol Hlth, Rockville, MD 20850 USA
来源
DRUG INFORMATION JOURNAL | 1998年 / 32卷 / 01期
关键词
subgroup; clinical trials; gender effect; medical devices;
D O I
暂无
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
One purpose of a clinical trial is to evaluate the safely and effectiveness of a medical treatment or device based an a representative sample of people from the targeted population. An additional issue of interest to many researchers, however; is: for what patient group a given treatment is most beneficial or poses an increased risk. Subgroup analyses are usually performed to attempt to answer these questions. The results of subgroup analyses must be interpreted bearing in mind the conditions under which the clinical trial was designed and analyzed and the limitations associated with such analyses. This article discusses interpretation of subgroup analyses in clinical trials with emphasis on special considerations related to medical devices. The questions of interest are: under what conditions should subgroup analyses be performed and how, should the results be interpreted from a regulatory perspective for medical device clinical trials?
引用
收藏
页码:213 / 220
页数:8
相关论文
共 50 条
  • [1] Interpretation of Subgroup Analyses in Medical Device Clinical Trials
    Pamela E. Scott
    Gregory Campbell
    [J]. Drug information journal : DIJ / Drug Information Association, 1998, 32 (1): : 213 - 220
  • [2] Subgroup analyses in clinical trials - Reply
    Wang, Rui
    Lagakos, Stephen W.
    Drazen, Jeffrey M.
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2008, 358 (11): : 1199 - 1200
  • [3] Subgroup Analyses in Nephrology Clinical Trials
    Fishbane, Steven
    Shah, Hitesh H.
    Kataria, Ashish
    Shirazian, Shayan
    Agarwal, Rajiv
    [J]. CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY, 2012, 7 (11): : 1872 - 1876
  • [4] Therapeutic trials: interpretation of subgroup and composite criteria analyses
    Touze, Emmanuel
    Trinquart, Ludovic
    [J]. SANG THROMBOSE VAISSEAUX, 2011, 23 (08): : 416 - 425
  • [5] On problems related to subgroup analyses in clinical trials
    Schmoor, C
    [J]. ONKOLOGIE, 2000, 23 (04): : 346 - 351
  • [6] More on subgroup analyses in clinical trials - Reply
    Wang, Rui
    Lagakos, Stephen W.
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2008, 358 (19): : 2076 - 2077
  • [7] CLINICAL-TRIALS - SUBGROUP ANALYSES - REPLY
    NOWAK, R
    [J]. SCIENCE, 1994, 265 (5176) : 1158 - 1158
  • [8] Issues in subgroup analyses and meta-analyses of clinical trials
    Bigger, JT
    [J]. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, 2003, 14 (09) : S6 - S8
  • [9] AN OVERVIEW OF STATISTICAL AND REGULATORY ISSUES IN THE PLANNING, ANALYSIS, AND INTERPRETATION OF SUBGROUP ANALYSES IN CONFIRMATORY CLINICAL TRIALS
    Hemmings, Robert
    [J]. JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2014, 24 (01) : 4 - 18
  • [10] Adjusted significance levels for subgroup analyses in clinical trials
    Spiessens, Bart
    Debois, Muriel
    [J]. CONTEMPORARY CLINICAL TRIALS, 2010, 31 (06) : 647 - 656