2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of...

26
!"#$%"%&'()*& ,%-%(./0 10% 2($3% *4 5678 9& ( :9;0 <.%=($%&/% 8%>&; 8("3%$ ?@ 8/03"(/0%.A 58/ <07 8'3B%&' C#9B%"9*$*;DA 5/?9$$ E&9=%.-9'D -("3%$@-/03"(/0%.F"(9$@"/;9$$@/(

Transcript of 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of...

Page 1: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

!"#$%"%&'()*&+,%-%(./0+

10%+2($3%+*4+5678+9&+(+:9;0+<.%=($%&/%+8%>&;+

8("3%$+?@+8/03"(/0%.A+58/+<07+8'3B%&'+C#9B%"9*$*;DA+5/?9$$+E&9=%.-9'D+

-("3%$@-/03"(/0%.F"(9$@"/;9$$@/(+

+

Page 2: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

G(/H;.*3&B+

8*3./%I+J:6A+(&B+5(B03H(.+<(9@+K5(##9&;+'0%+$(&B-/(#%+(&B+L3($9'D+*4+1G+B9(;&*-)/+.%-%(./0M+NO*=%"P%.+QRA+RSSTUI+QVRW@+

!"#$%&$'()*+,(-.$+/0*12$$NQU  5(X*.9'D+*4+-'3B9%-+%=($3()&;+

B9(;&*-)/+'%-'-+4*.+1G+(.%+%(.$D+#0(-%+-'3B9%-+*4+'%-'+(//3.(/D+

NRU  2%.D+$9Y$%+B('(+*&+#()%&'+*3'/*"%-A+/*-'Z%[%/)=%&%--+(&B+9"#(/'+9&+.%($+\*.$B+-%>&;-@+

0.5%

0.5%

0.5%34.0%

34.0%

34.0%19.4%

19.4%

19.4%33.4%

33.4%

33.4%3.2%

3.2%

3.2%1.2%

1.2%

1.2%9.3%

9.3%

9.3%Phase 0: Pre-clinical stage, development of new diagnostic tools

Phase 0: Pre-clinical stage, development of new diagnostic tools

Phase 0: Pre-clinical stage, development of new diagnostic toolsPhase I: Discriminatrory ability, normal range of values for the test

Phase I: Discriminatrory ability, normal range of values for the test

Phase I: Discriminatrory ability, normal range of values for the testPhase II: Accuracy in a case-control setting

Phase II: Accuracy in a case-control setting

Phase II: Accuracy in a case-control settingPhase IIIa: Accuracy in a population where the test is clinically indicated

Phase IIIa: Accuracy in a population where the test is clinically indicated

Phase IIIa: Accuracy in a population where the test is clinically indicatedPhase IIIb: Incremental or added value

Phase IIIb: Incremental or added value

Phase IIIb: Incremental or added valuePhase IVa: Clinical consequences of introducing the test, clinical trial or impact study

Phase IVa: Clinical consequences of introducing the test, clinical trial or impact study

Phase IVa: Clinical consequences of introducing the test, clinical trial or impact studyPhase IVb: Optimizing an existing test

Phase IVb: Optimizing an existing test

Phase IVb: Optimizing an existing testStudy design of studies evaluating markers and technologiesStudy design of studies evaluating markers and technologies

Study design of studies evaluating markers and technologies

Page 3: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

8'3BD+7%-9;&+

•  7%-9;&+–  ,%'.*-#%/)=%+(&($D-9-+*4+'%-'Z.%-3$'-+–  ]*$$*\Z3#+*4+/%.'(9&+;.*3#-+–  ^*&-%/3)=%$D+%&.*$$%B+#()%&'-+–  _$$+.%-3$'-+(.%+#%.+#()%&'+N&*'+#%.+-("#$%`'%-'U+–  5678+(-+(&+(BBZ*&+'%-'+'*+RZa+bO+

•  <.(;"()/+#0(-%+!!!+`+!2(+-'3BD+–  79(;&*-)/+3&/%.'(9&'D++–  !&/.%"%&'($+=($3%+–  ^*-'+#%.+/$9&9/($$D+9"#*.'(&'+*3'/*"%+–  N^$9&9/($+9"#(/'U++

+•  2($3%+*4+5678+'*+'%-'+4*.+

Q@  57, + +9&+ + +1GZ#()%&'-+R@  8Z+1G + +9& + +1GZ-3-#%/'-++

Page 4: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

8'3BD+8%>&;+c+<*#3$()*&+

•  340.5'6+$768.).+9$60/+:*.$;:<($–  <*#3$()*& + +dSSASSS+–  1G+9&/9B%&/% + +QeR`QSSASSS+–  f+P%$*\+gQ`B + +Wef+h1G+#()%&'-i+

+

•  4.=0$

–  1GZ#.%=($%&/%+ +QRe`QSSASSS+–  :!2Z#.%=($%&/% +R@df+h1G+#()%&'-i+

–  57,Z#.%=($%&/% +j@jfh($$+1G+#()%&'-i+

Samuel Schumacher
Samuel Schumacher
Photos by Curtis McElhinney - http://www.curtisvision.com/
Samuel Schumacher
Samuel Schumacher
Page 5: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

8'3BD+<(.)/9#(&'-+c+<.*/%--+

O1^<+B9(;&*-%-+#()%&'+

1%("+.%/%9=%-+

&*)k/()*&+

O3.-%+=9-9'-+#()%&'+

1(H%-+(+-("#$%+4.*"+

#()%&'+

8D"#'*"()/+:*3-%0*$B+^*&'(/'-+

5678+

RZa+bO+8"%(.-+c+++++Q+5678+

•  RSSRZRSQS+•  ^(-%Z/*&'(/'+-%'3#+•  ^*$$(P*.()*&+\9'0+<%.3=9(&+O1^<+•  RZa+bO+-"%(.-+l+Q+5678+`+#()%&'+

Page 6: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

63'/*"%+5%(-3.%-+

5678+4*.+57,+

5678+4*.++

8Z+1G+

63'/*"%+5%(-3.%-+

•  !&/.%"%&'($+D9%$B+5678+*=%.+-"%(.+

•  OO78Z+•  ^*-'`(BB9)*&($+

/(-%+B%'%/'%B+

•  OO757,+

•  ^*-'`/(-%+B%'%/'%B+

1G+<()

%&'-+

1G+83-#%

/'-+

]*$$*\ZE#+

79B+57,+/(-%-+.%/%9=%+57,+,mn+

79B++bOZ+5678l+

/(-%-+.%/%9=%+,mn+

Page 7: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

?%&%.($9o(P9$9'D+c+p9"9'()*&-++

•  8'3BD+#*#3$()*&+–  _B3$'+#3$"*&(.D+1G+–  p*\+:!2+–  :9;0+57,+–  1G+-3-#%/'-+q+1G+0*3-%0*$B+/*&'(/'-+

•  1G+'%-)&;+– 5678+–  Q+/3$'3.%`#()%&'+–  7*&%+9&+E&9=%.-9'D+$(P+

•  8*"%+(&($D-%-+&*'+k&($+•  O*+B('(+*&+:!2Z-'('3-+

Page 8: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

8'3BD+#(.)/9#(&'-+

Contaminated n=131

Missing sample or culture-result

n=72

TB-Patients included in analysis n=2,557

Contaminated n=162

TB-suspects included in analysis n=1,453

No cough n=11,128

TB-Patients n=2,629

Contacts of TB-patients identified n=12,581

Negative by culture n=964

Positive by culture n=1,431

Negative by culture n=1,203

Positive by culture n=119

1G+<()%&'-+ 1G+83-#%/'-+

Page 9: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

,%-3$'-+Q`a+

5678+4*.+781+

_BB9)*&($+=($3%+*4+5678+*=%.+ambO+

63'/*"%+5%(-3.%-+

•  !&/.%"%&'($+D9%$B+5678 +aWf+NTdf^!+RefZWafU+•  OO78Z + + +ad+NTdf^!+ReZWrU+•  ^*-'`(BB9)*@+/(-%+B%'%/'@ +gWTr+

•  OO757, + +QS+NTdf^!+TZQRU+•  ^*-'`/(-%+B%'%/'%B +gQWR+

1G+<()

%&'-+

1G+83-#%

/'-+

Page 10: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

,%-3$'-+R`a+

]*$$*\ZE#++++++

+++++++++++++++++++

jf+($.%(BD+*&+57,+,m+

dQf+,m+\(-+&%=%.+(B(#'%B+

WRf+$*&;+B%$(D+

erf+9&9)('%B+,m+

af+B9%B+P%4*.%+,m+

RTf+-D"#'*"-+

.%-*$=%B+\`*+,m+

63'/*"%+5%(-3.%-+1G

+<()

%&'-+

1G+83-#%

/'-+

•  !&/.%"%&'($+D9%$B+5678 +aWf+NTdf^!+RefZWafU+•  OO7 + + +ad+NTdf^!+ReZWrU+•  ^*-'`(BB9)*@+/(-%+B%'%/'@ +gWTr+

•  OO7 + + +QS+NTdf^!+TZQRU+•  ^*-'`/(-%+B%'%/'%B +gQWR+

Page 11: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

,%-3$'-+a`a+

($.%(BD+jf+

&%=%.+dQf+

Q+"*&'0+af+R+"*&'0-+df+

a+"*&'0-+ef+

W+"*&'0-+Wf+

d+"*&'0-+rf+

e+"*&'0-+df+

T+"*&'0-+df+QR+"*&'0-+af+RW+"*&'0-+af+

6'0%.+WRf+

Page 12: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

^*&/$3-9*&-+c+s3%-)*&-+NQ`aU+

+J%+&%%B+'*+;*+P%D*&B+(//3.(/D+

+

c+

+

E&B%.-'(&B+P%Y%.+\0('+0(##%&-++

P%'\%%&+(//3.(/D+(&B+#()%&'+9"#(/'+

Page 13: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

^*&/$3-9*&-+c+s3%-)*&-+NQ`aU+

+>.$)..*$/6$?6$5.16)*$(,,0=(,1$

:*\+B9.%/'+`+9&B9.%/'+9-+'0%+$9&H+P%'\%%&++(//3.(/D+(&B+#()%&'+*3'/*"%-n+

++!+E&B%.-'(&B+P%Y%.+\0%.%+'09&;-+;%'+++ +Kp*-'+9&+1.(&-$()*&M+(&B+0*\+\%+/(&+ + + ++ +"9&9"9o%+$*--+

–  B9(;&*-)/+'09&H9&;+–  /$9&9/($+B%/9-9*&Z"(H9&;+–  #()%&'+c+#.*=9B%.+#.%4%.%&/%-+

Page 14: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools
Page 15: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

5678+4*.+^(-%Z]9&B9&;+

1G+-3-#%/'-+

8l+

8Z^l+t-%$4Z/3.%Bu+

,m+P%4*.%+5678+.%-3$'+p*-'+'*+4*$$*\Z3#+

G%&%k'+4.*"+5678+

8Z^Z+

O*'%I+k;3.%+4*.+9$$3-'.()=%+#3.#*-%-v+&*'+'*+-/($%+

Kp*-'+9&+1.(&-$()*&Mn+

Page 16: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

5678+4*.+57,+

1G+<()%&'-+.%/%9=9&;+

781+

,%-9-'(&'+1G+ G%&%k'+4.*"+781+

8%&-9)=%++1G+

O*'%I+k;3.%+4*.+9$$3-'.()=%+#3.#*-%-v+&*'+'*+-/($%+

,m+&*'+"*B9k%B+

57,+,m+P%4*.%+5678+.%-3$'+p*-'+'*+4*$$*\Z3#+

Kp*-'+9&+1.(&-$()*&Mn+

Page 17: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

^*&/$3-9*&-+c+s3%-)*&-+NR`aU+

+J%+&%%B+"*.%+-'3B9%-+`+&%\+"%(-3.%-+'*+0%$#+

#.9*.9)o%+++ + + + + +w+\0('+'%-'-++

+ + + + + +w+\0('+'%-)&;+(&B++

+ + + + + +w+\0('+;.*3#-++

.%-*3./%-+(.%+"*-'+%x/9%&'$D+-#%&'+*&+

Page 18: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

0

50

100

150

200

250

300

0 10 20 30 40 50 60 70 80 90 100

For TB prevalence in TB-suspects of 2%

For TB prevalence in TB-suspects of 4%

For TB prevalence in TB-suspects of 8%

For TB prevalence in TB-suspects of 16%

For TB prevalence in TB-suspects of 32%

Num

ber o

f liq

uid-

cultu

res

need

ed to

dia

gnos

e

one

smea

r-ne

gativ

e/cu

lture

-pos

itive

cas

e

Proportion of TB-patients with smear-negative/culture-positive disease [%]

Data from this study

Setting with low TB- and HIV-rates

Setting with high TB- and HIV-rates

TB-prevalence in TB-suspects

2% 4% 8% 16% 32%

A

Page 19: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

0

50

100

150

200

250

300

350

400

450

500

0 10 20 30 40 50 60

For TB-suspects

For smear-negative patients

For smear-positive patients

Num

ber o

f liq

uid-

cultu

res

need

ed

to d

iagn

ose

one

MD

RTB

cas

e

Proportion of TB-patients with MDRTB [%]

Data from this study

Setting with low TB- and HIV-rates but high MDRTB-rates

Setting with high TB- and HIV- but low MDRTB-rates

B

Page 20: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

^*&/$3-9*&-+c+s3%-)*&-+Na`aU+

+:*\+"(&D+'%-'-+(.%+\%+\9$$9&;+'*+B*++

6,++0*\+"3/0+ggg+(.%+\%+\9$$9&;+'*+-#%&B+

+'*+B9(;&*-%+*&%+%m'.(+/(-%+*4+8Z+1G+*.+57,1Gn++c++

_.%+&%\+'%-'-+($\(D-+'0%+P%-'+3-%++*4+(=(9$(P$%+43&B-n+

Page 21: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

• ,%-3$'I+5(&D+#()%&'-+'%-'%B+($'0*3;0+yR+\%%H-+/*3;0+!+$*\%.+D9%$B+*4+-"%(.++

• ^*&/$3-9*&I+'%-)&;+'0%+#()%&'-+\9'0+yR+\%%H-+/*3;0+-0*3$B+&*'+P%+B*&%+

• GE1I+OO7+'*+B%'%/'+(+8l+/(-%+("*&;+1GZ-3-#%/'-+\9'0+yR+\%%H-+/*3;0+\(-z+aQ+

Page 22: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

@))68(A8.$(--=6(,B.+$/6$$<(C:)?$5.D.=$0+.$6E$.&:+A)?$/66'++

Page 23: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

@))68(A8.$(--=6(,B.+$/6$F(+.$G:)*:)?+

Page 24: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

>B(/$B(--.)+$5.E6=.$H.$/.+/I$+

•  J0*+;%'-+(+-"%(.n+

•  J0*+;%'-+(+P%Y%.+'%-'+*&+'*#`9&-'%(Bn+

•  J0%.%+(.%+($$+'0%+8l+/(-%-+\%+&%=%.+-%%n+

Page 25: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

_/H&*\$%B;%"%&'-+

!"#$%#&'()!*)+,-,!.(!*/).(0%11(2(341%#$5(65748(!9"#$5:9#.(;<=(>?4(;411@9A4(>B"87.(>?4(-%B(<5114C(-74D5B7(>B"87.(/*<(5#$(7?4(@?5B%7C(*!<E)(

Research group IFHAD: Innovation For Health And Development, a collaboration between: Peru: NGO A B PRISMA, Universidad Peruana Cayetano Heredia UK Imperial College London, London School of Hygiene & Tropical Medicine USA: Johns Hopkins Bloomberg School of Public Health, Tulane University

Page 26: 2011-07-07 DxCourse MyPPT web · 2018-05-01 · 9.3% Phase 0: Pre-clinical stage, development of new diagnostic tools Phase 0: Pre-clinical stage, development of new diagnostic tools

10(&H+D*3+4*.+D*3.+(Y%&)*&+

-("3%$@-/03"(/0%.F"(9$@"/;9$$@/(+

Samuel Schumacher
Samuel Schumacher
Samuel Schumacher
Photo by Brendan Hoffman - www.brendanhoffman.com/
Samuel Schumacher