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[分享] Clinical Trials in Oncology (2nd edition, 2003)

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sampson2010 发表于 2014-8-25 13:45:09 | 显示全部楼层 |阅读模式

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本帖最后由 sampson2010 于 2014-8-25 13:47 编辑 $ L0 x  b3 ]& ^- m/ B/ C; x

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: r& A3 q$ e2 M) V+ u+ k/ ^% ?& ]对于本书的详细介绍看这里:http://www.epiman.cn/thread-13369-1-2.html9 R5 h) z6 I4 f7 s" |" H

6 e8 p, H( e, q$ X7 S( s鉴于上面帖子里的附件是分章节挂出,不便于下载阅读,现将整本挂出供大家下载学习~~
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2 P* ^! o9 e# U6 g0 b) l7 MTable of contents :
+ G8 B9 Q/ K5 ?, i  SInterdisciplinary Statistics CLINICAL TRIALS in ONCOLOGY, Second Edition......Page 2
( v# a+ i7 y7 m& B- o5 S- m+ MAcknowlegdments......Page 29
7 J. f0 t' _! S; `. W: XContents......Page 24/ Z9 K( L' q' p& `
Contents......Page 0
8 Z6 o" n. s5 o+ p0 G# a1.1 A brief history of clinical trials......Page 306 ^9 b3 X' X( p! W7 i
1.2 The Southwest Oncology Group......Page 35
* }1 f, z: C- Z# }1 \) K* N; J' l1.3 Example trials......Page 36/ n) ~& p6 G1 v* Y
1.4 The reason for this book......Page 38
' n* V" Y5 i. K" f: w  e7 A( g2.1 Introduction......Page 39
' V* z" t! j, ~. r1 c2.2 The Phase II trial — estimation......Page 473 o( m9 b- c8 v( U% p
2.3 The Phase III trial – hypothesis testing......Page 51
( [$ Q5 @2 r7 o8 P# M2.3.1 Response as the outcome......Page 52
, U2 C" E0 y+ ~3 }  t2.3.2 Survival as the outcome......Page 58& V" I5 u' y2 U3 W- m2 A0 H9 V, d
2.4 The proportional hazards model......Page 65+ J9 Y: u  f1 {  {
2.5 Sample size calculations......Page 671 ]0 p2 p+ F2 v, b. I4 v" h  W3 \
2.6 Concluding remarks......Page 68
8 p, Q' W' w( q3 ?. m2 p$ L3.1 Introduction......Page 69
4 ^/ V& `2 V8 c; x; D/ QRYRY3 Uligibility treatments endpoints......Page 70
/ K: m; x. m3 M& u9 |0 PRYRYM Assumptions for sample size calculation......Page 71
# \& n( h: e! j( h$ a$ P8 eRYRYR Traditional designs......Page 76
# E* J: f; O: z; m' IRYRY3 Newer Phase I designs......Page 772 u$ w/ j# {, _& W+ N
RYRY: Eonsiderations for biologic agents......Page 804 ^9 W1 }; \: k' ~4 V! _
3.4 Phase II trials......Page 81: e  L9 d/ U6 ]
RY:YR The Standard Southwest Oncology roup Phase II design......Page 82
6 g# {& x# X- u  i/ O. VactivityY......Page 844 c% c6 [- _9 R7 F
not......Page 86
! [" B; x# h+ x: L/ I3 Z7 ]; W$ Kpilot studiesj......Page 89
' _7 k2 o' R4 i% |$ F/ P; g) lStratiYcation factors......Page 90
% V. k* ]3 Z1 T( O0 _/ hRandomization schemes......Page 91. c2 U/ |* k2 F
adaptive allocation......Page 92
) p: s* h& b; X+ A- Y5 Cintent to treat principle......Page 93
0 @  [( K2 G  e3 grandomized consent designs......Page 941 U* p% h% \; i$ V3 O5 d
Placebo’controlled......Page 950 g" @3 L, `7 X/ H! M6 W: \
RYMY3 Two’arm trials......Page 97
, Y2 y! _" `' g% J- W' r- }) x" Cprove......Page 98
9 ^8 z" h& r* i2 @proportional hazards assumptionY......Page 991 A* K, B2 l+ ^8 m! p0 [$ V
Multiple endpoints......Page 100( b1 H! b! x" s) N+ B. {5 D; z
proving......Page 1014 p% C  a* G: Y5 _8 i
3.6 Conclusion......Page 1049 Y9 U" Q, m/ E$ E" W
4.1 Introduction......Page 106
5 d4 E6 i2 Y- r3 @; Q& |' X4.2 Types of multi-arm trials......Page 107
, V+ i4 T8 x. M2 D9 f" m4.3 Significance level......Page 110
1 b- J6 ^- B& J4.4 Power......Page 1112 q3 I2 k4 u9 H$ Z% @+ V) g
5.1 Planned interim analyses......Page 1232 ]! E' g$ p; D  M9 a
5.2 Data monitoring committees: Rationale and responsibilities......Page 129
; _8 I7 r% X+ ]6 T/ p% c5.3 Monitoring committees: Composition......Page 133
9 K6 K& B: E" R" J4 p9 _8 J- \5.4 Examples......Page 1383 x& {! j  [$ E( j3 v4 ?/ N% k
5.5 Concluding remarks......Page 148
9 {6 ?8 K9 I! P+ G* }/ _8 i6.1 Introduction: Why worry?......Page 149
' v: D7 r- _$ r6.2 Protocol development......Page 1545 ?& U1 W! w; e0 C% f5 ]
6.3 Data collection......Page 162! J5 H' g" Y9 z% V3 W! J2 h
6.4 Protocol management and evaluation......Page 169
! @: }: G# T% z2 E! D, u6.5 Quality assurance audits......Page 175
. j+ ]3 u2 A$ O; Q7 @$ `* e* z- V8 X6.6 Training......Page 176$ J& z, q; \2 s/ T
6.7 Data base management......Page 177
: z: G+ x( N1 u' l9 c! @: E$ s6.8 Conclusion......Page 180
4 M+ O7 K, \) x9 A: w6 ^8 K& o6.9 Appendix: Examples......Page 181
; i# e1 [, X6 {, {1 M7 N. t2 ]CHAPTER 7: Reporting of Results......Page 190
2 s/ P, L$ I+ j. I4 \7.1 Timing of report......Page 191+ }5 p3 W- ]; h
7.2 Required information......Page 193
8 n; A0 |3 F/ q4 u7.3 Analyses......Page 195
/ w) G( T  J* y0 h  g. l7.4 Conclusion......Page 204# m3 v- z- Q: z" `- q3 R4 _% u
8.2 Historical controls......Page 205
2 `; T. o' j- l8 r) P  M) i8.3 Competing risks......Page 212
0 ]; e# {; ]: i2 P  t8.4 Outcome by outcome analyses......Page 219) f* g8 O7 ^$ w
8.5 Subset analyses......Page 227
4 ?. y: V% \( M% @; @8.6 Surrogate endpoints......Page 230
4 T( q* R* l3 F9.1 Introduction......Page 233# M) N: l; ~$ l; ?8 Q, u- B' w
9.2 Some background and notation......Page 234
4 ~2 G0 v) O) A  @7 H* Q9.3 Identification of prognostic factors......Page 236
. ]* P6 K. Y' \# d# y1 N5 \9.4 Forming prognostic groups......Page 243
2 F" _8 d- Z+ h3 l/ q* O9.5 Analysis of microarray data......Page 2488 W" L' t9 S+ A% x5 O
9.6 Meta-Analysis......Page 250
1 S$ t7 b6 a5 G" A3 |' q9.7 Concluding remarks......Page 256
5 O, H* r/ S6 E9 W6 D& ], JCHAPTER 10: Summary and Conclusions......Page 257
1 X2 D+ F' ?* XBibliography......Page 4# Q/ g$ S3 r( p8 H5 z+ b) F
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