ライフサイエンスコーパス: surrogate end point

1 umab, using reduction of amyloid plaque as a surrogate end point.

2 hose episodes requiring health care use as a surrogate end point.

3 PTE) explained are requisites for a suitable surrogate end point.

4 clinical events, and may not be a sufficient surrogate end point.

5 emission computed tomographic) imaging as a surrogate end point.

6 red twenty-one primary end points (81%) were surrogate end points.

7 led, and most primary outcomes were based on surrogate end points.

8 n between treatment effects on OS and on the surrogate end points.

9 pancies in reporting, and an overreliance on surrogate end points.

10 shed more quickly than those that focused on surrogate end points.

11 FS, suggesting that these biomarkers are not surrogate end points.

12 e needed for identifying the most predictive surrogate end points.

13 were a focus on clinical events rather than surrogate end points (adjusted publication rate ratio, 2

14 enefits of earlier treatment access based on surrogate end points against the risks of clinical uncer

15 y oncology RCTs now largely measure putative surrogate end points and are almost exclusively funded b

16 lesser albuminuria emphasized the fallacy of surrogate end points and argue against nephroprotective

17 n in long-term studies, including the use of surrogate end points and biomarkers.

18 gly relevant in clinical trials as potential surrogate end points and for patient management as clini

19 utcome was the correlation between candidate surrogate end points and OS.

20 f COPD Longitudinally to Identify Predictive Surrogate End-points), and Framingham Heart studies.

21 ents in cardiovascular disease risk factors, surrogate end points, and mortality in blacks and other

22 ing access to new treatments on the basis of surrogate end points, and PFS in particular, likely vari

23 Surrogate end points are commonly used to estimate treat

24 reserved ejection fraction (HFpEF), feasible surrogate end points are needed for phase II trials.

25 Surrogate end points are needed to assess whether treatm

26 to March 2022, all approvals were based on a surrogate end point as the primary end point, with no tr

27 Pivotal trials using surrogate end points as their primary outcome formed the

28 F, IGFBP-3, and IGF-I/IGFBP-3 could serve as surrogate end point biomarkers of 9-cis-RA treatment.

29 n development of prostate carcinogenesis and surrogate end point biomarkers related to prostate cance

30 ventive targets and drugs, risk markers, and surrogate end point biomarkers; new preclinical drug-tes

31 standard practice, because a well validated surrogate end point can accelerate the outcome assessmen

32 Here, we evaluate how analyses of certain surrogate end points can be used for inferring clinicall

33 bly portend prognosis and treatment benefit (surrogate end points) can accelerate therapy development

34 Although surrogate end point candidates have been evaluated in th

35 The prime motivation for the use of a surrogate end point concerns the possible reduction in s

36 f COPD Longitudinally to Identify Predictive Surrogate End-points) COPD cases with microarray data fo

37 Such proposed surrogate end points could overcome limits of pCR and pr

38 f COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE) cohort with 3 years of cl

39 f COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE) study.ResultsA total of 7

40 ements for the FDA to adopt a biomarker as a surrogate end point for a clinical trial, and to inform

41 tality, evidence validating nonfatal MI as a surrogate end point for all-cause or cardiovascular (CV)

42 protein model has potential as a "universal" surrogate end point for cardiovascular risk.

43 ion using brachial-artery FMD may serve as a surrogate end point for cardiovascular risk.

44 To assess the use of GFR slope as a surrogate end point for CKD progression, we performed a

45 the distal common carotid artery is a useful surrogate end point for clinical coronary events.

46 f coronary artery disease is assumed to be a surrogate end point for clinical coronary events.

47 nse to therapy has never been validated as a surrogate end point for clinical events in pulmonary art

48 atment effect, has only modest validity as a surrogate end point for clinical events, and may not be

49 nce the current Banff system and be a useful surrogate end point for clinical intervention trials.

50 MRS data may serve as a useful biomarker and surrogate end point for clinical trials of FM.

51 ducible, this technique may provide a useful surrogate end point for clinical trials with appreciable

52 trials does not support the use of pCR as a surrogate end point for DFS and OS in patients with brea

53 opics include use of MRD as a prognostic and surrogate end point for drug testing; selection of the t

54 30%-40% decline in eGFR after AKI could be a surrogate end point for ESRD in trials of AKI prevention

55 s has been widely accepted as an appropriate surrogate end point for HIV disease progression, and it

56 e response (pCR) is an optimal outcome and a surrogate end point for improved disease-free and overal

57 CR) is supported by regulatory agencies as a surrogate end point for long-term patients' clinical out

58 e investigated whether eGFR can be used as a surrogate end point for measured GFR (mGFR) when searchi

59 d not establish short-term OPL response as a surrogate end point for oral cancer-free survival.

60 but not event-free survival, is a validated surrogate end point for overall survival (OS) in men tre

61 d a decrease in interdialytic weight gain, a surrogate end point for patient self-management.

62 pCR is a suitable surrogate end point for patients with luminal B/HER2-neg

63 itiation of induction therapy as a potential surrogate end point for PFS in first-line FL therapy.

64 notherapy trials demonstrates that CR30 is a surrogate end point for PFS in first-line FL treatment t

65 e additional support for the use of MRD as a surrogate end point for PFS in patients receiving FCR.

66 Plaque inflammation is often used as a surrogate end point for plaque vulnerability in animals.

67 ction treatment with chemoimmunotherapy as a surrogate end point for progression-free survival (PFS)

68 ss and could potentially be used as an early surrogate end point for studies aiming at finite therapy

69 athologic treatment response is a meaningful surrogate end point for survival has yet to be determine

70 ete response (pCR) is increasingly used as a surrogate end point for survival in randomized clinical

71 ese results suggest that the use of pCR as a surrogate end point for survival should be reexamined an

72 measurement of infarct size is an attractive surrogate end point for the early assessment of new ther

73 Decline in eGFR is a biologically plausible surrogate end point for the progression of CKD in clinic

74 ether changes in CO reserve can be used as a surrogate end point for therapeutic response.

75 nfection during infancy and could serve as a surrogate end point for vaccine trials.

76 US Food and Drug Administration has approved surrogate end points for 120 conditions, but not for CAD

77 and partial remission (PR) of proteinuria as surrogate end points for a treatment effect on ESRD in p

78 2 years, making them potentially suitable as surrogate end points for clinical trials.

79 val in large patient populations, and offers surrogate end points for clinical trials.

80 RORA as risk factors for GA and as potential surrogate end points for future interventional studies i

81 ogress is needed to identify the most useful surrogate end points for future MF trials and better ser

82 ments during placental malaria might provide surrogate end points for interventional trials, but exis

83 the community as a novel method to generate surrogate end points for large-scale clinical studies.

84 f intermediate clinical end points (ICEs) as surrogate end points for OS in recurrent prostate cancer

85 Both rPFS and cPFS appear to be promising surrogate end points for OS.

86 onducted with varying designs and often with surrogate end points for overall survival (OS).

87 However, the use of surrogate end points for overall survival is increasingl

88 pted as optimal, the utility and validity of surrogate end points for predicting clinical coronary ev

89 gest that resting hemodynamics are not valid surrogate end points for short-term events in PAH clinic

90 rogate end points listed in the FDA table of surrogate end points for the same indication.

91 n of patient immunophenotyping and potential surrogate end points for vascular inflammation.

92 y important end point, but its validity as a surrogate end point has never been shown.

93 er assessment of response and PSA level as a surrogate end point have been widely adopted.

94 at a reduction in NfL is a reasonably likely surrogate end-point (i.e. reasonably likely to predict c

95 Incorporation of MRD as a surrogate end point in clinical trials would enable shor

96 value to the WFNS score, and is a promising surrogate end point in clinical trials.

97 estone for patient counseling and could be a surrogate end point in clinical trials.

98 sease activity in clinical practice and as a surrogate end point in clinical trials.

99 ture can be used for drug discovery and as a surrogate end point in HCC chemoprevention clinical tria

100 loss in AMD and could be used as an earlier surrogate end point in interventional trials targeting t

101 able data suggest that CR could be used as a surrogate end point in primary MN, whereas PR seems reas

102 Albuminuria has been proposed as a surrogate end point in randomized clinical trials of ren

103 oes not support pCR used alone as a reliable surrogate end point in regulatory neoadjuvant RCTs for B

104 Carotid B-mode ultrasound may serve as a surrogate end point in SLE intervention trials and clini

105 of mean maximum IMT in carotid arteries, the surrogate end point in this study, did not differ betwee

106 ffects on virus load and other postinfection surrogate end points in an efficacy trial is complicated

107 support clinical decision-making and provide surrogate end points in clinical heart failure trials.

108 Interest in the use of surrogate end points in clinical studies is increasing.

109 have analyzed the possible potentials of the surrogate end points in clinical studies of patients wit

110 udies, enhance patient selection and provide surrogate end points in clinical trials, and ultimately

111 outine and may support establishing anatomic surrogate end points in clinical trials.

112 upport the strategy of using EAP measures as surrogate end points in early-stage procognitive interve

113 d other pathologic measures may be useful as surrogate end points in evaluating and understanding new

114 lly relevant outcomes, making them potential surrogate end points in follow-up studies.

115 t that rim area measurements may be suitable surrogate end points in glaucoma clinical trials.

116 parameters of right ventricular function as surrogate end points in multicentre clinical trials of n

117 sease-free survival are increasingly used as surrogate end points in oncology research, frequently se

118 recommendations on how to apply and evaluate surrogate end points in research and clinical practice.

119 muscle diseases and discuss their utility as surrogate end points in therapeutic trials.

120 es), gastric volume and pH have been used as surrogate end-points in many aspiration studies; however

121 Candidate surrogate end points included TTD; TTNT; PFS based on im

122 We also describe alternative surrogate end points, including combined end points that

123 A surrogate end point is defined as a measurement that can

124 g., mortality or quality of life), whereas a surrogate end point is one biologically closer to the di

125 perhaps more important, aspect of measuring surrogate end points is that they increase our understan

126 efficacy and 39 (64%) were approved based on surrogate end points listed in the FDA table for the sam

127 indications, 51 (98%) were approved based on surrogate end points listed in the FDA table of surrogat

128 l modifications to PGs can serve as in vitro surrogate end point markers for chronological age, the e

129 ; use of molecular and histologic markers as surrogate end point markers; collection of epidemiologic

130 Surrogate end points may be used as proxy for more robus

131 Decisions based on surrogate end points may expedite regulatory approval bu

132 f COPD Longitudinally to Identify Predictive Surrogate End-points), MESA (Multi-Ethnic Study of Ather

133 hat a progression event has occurred was the surrogate end point most highly correlated with OS for a

134 ue at trial level of potentially more robust surrogate end points needs to be urgently tested.

135 The association of MRD status as a surrogate end point of clinical outcome in chronic lymph

136 stigators accepted changes in PSA level as a surrogate end point of response.

137 ould, therefore, be of value to have a rapid surrogate end point of tumor response that could be used

138 This was supported by improvements in surrogate end points of anginal episodes, use of antiang

139 randomization and after 2 weeks, as primary surrogate end points of efficacy and safety, respectivel

140 to coronary lesion progression for all three surrogate end points (P<.05).

141 disease and amyotrophic lateral sclerosis as surrogate end points reasonably likely to predict clinic

142 in routine practice, and the use of MRD as a surrogate end point remains controversial to some.

143 ions for new agents and to develop validated surrogate end points, so that novel agents can be tested

144 For randomized trials using surrogate end points such as blood pressure, we selected

145 nodeficiency virus (HIV) disease, the use of surrogate end points such as HIV-1 RNA is becoming incre

146 from promising proof-of-concept trials with surrogate end points such as infarct size to larger clin

147 d based on overall survival (OS) or putative surrogate end points such as progression-free survival (

148 Surrogate end points, such as pathological response, are

149 Posttreatment surrogate end points, such as progression of disease wit

150 s have emerged regarding the use of putative surrogate end points, such as progression-free survival

151 g medical writers were more likely to report surrogate end points, such as progression-free survival,

152 Regardless of funding source, trials using surrogate end points, such as quantitative angiography,

153 Accelerated approval (AA) is based on a surrogate end point that is less well established but th

154 Concentrations of raxibacumab provide a surrogate end point that should be predictive of clinica

155 In the United States, surrogate end points that are reasonably likely to predi

156 ct, MRD measurements might well be used as a surrogate end point, thereby significantly shortening th

157 iDFS with sufficient FUP is an acceptable surrogate end point to confidently anticipate final OS r

158 development, the CS activity was chosen as a surrogate end point to conservatively assess hemostatic

159 ima-media thickness is used as a noninvasive surrogate end point to measure progression of atheroscle

160 It has the potential to serve as a surrogate end point to uncover advantages of new therapi

161 e nonrandomized, unblinded trial designs and surrogate end points to assess efficacy.

162 ol excluded adults older than 80 years, used surrogate end points to evaluate microvascular outcomes

163 Using surrogate end points to grant drug approvals is justifie

164 The primary outcome was correlation of surrogate end points to OS.

165 omatic and presymptomatic disease or provide surrogate end-points to demonstrate clinical efficacy of

166 this study serves to emphasize the need for surrogate end point validation in neoadjuvant endocrine

167 idence, such as single-arm trials focused on surrogate end points with short-term follow-up whose par