toxcast revisited: a comprehensive statistical analysis of

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ToxCast Revisited: A Comprehensive Statistical Analysis of the In Vitro-to-In Vivo Predictive Capacity of High-Throughput Toxicity Screens Russ Wolfinger Director of Scientific Discovery and Genomics SAS Institute Inc., Cary, NC SRP Meeting October 24, 2012

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Page 1: ToxCast Revisited: A Comprehensive Statistical Analysis of

ToxCast Revisited: A Comprehensive Statistical

Analysis of the In Vitro-to-In Vivo Predictive

Capacity of High-Throughput Toxicity Screens

Russ Wolfinger

Director of Scientific Discovery and GenomicsSAS Institute Inc., Cary, NC

SRP Meeting October 24, 2012

Page 2: ToxCast Revisited: A Comprehensive Statistical Analysis of
Page 3: ToxCast Revisited: A Comprehensive Statistical Analysis of

ToxCast Data from the EPA

Activity of the

Chemical Based on

Concentration in

the Well

Predictive

Combinations

of Assays

In Vivo Hazard

Prediction and

Prioritization

In Vivo

Endpoints

A_51_P108645 <= -0.80

Terminal

Node 1

N = 3

A_51_P161890 <= 0.01

Terminal

Node 2

N = 6

A_51_P161890 > 0.01

Terminal

Node 3

N = 10

A_51_P108645 > -0.80

Node 2

A_51_P161890 <= 0.01

Node 1

A_51_P108645 <= -0.80 In Vitro High

Throughput

Screens

~300 Biochemical

Assays

~200 Cellular

Assays

9 Phase I Chemicals

(Pesticides/HPV)

30

Page 4: ToxCast Revisited: A Comprehensive Statistical Analysis of

Reproductive toxicity signature

74% Balanced Accuracy

Pre-filtered assays and lumped subset

into into 6 classes based on genes and

functional grouping

Only study with external validation set

Rat liver tumor signature

No formal classification statistical analysis

cross-validation) (

Developmental toxicity signature

71% Balanced Accuracy

Pre-filtered assays and aggregated

assays based on genes and GO

categories

Vascular development signature

80% Accuracy

Currently Published Work on Predictive Toxicity Signatures in ToxCast

Signature Development

Page 5: ToxCast Revisited: A Comprehensive Statistical Analysis of

Why is a Software Company Getting Involved with ToxCast?

Our life sciences team has collaborated with the EPA, Hamner

Institute, NIEHS, UNC, and NC State for many years, and has its

roots in toxicology-based microarray data analysis.

The ToxCast data is highly valuable and presents numerous

analytical challenges, several of which JMP Genomics software can

help address.

We wanted to test and stretch the software in new directions and

participate in the project by providing, as much as possible, a

“neutral third party” assessment of the predictive performance of the

assays.

Previous work in collaboration with Fred Wright at UNC; current

work in collaboration with Rusty Thomas at Hamner.

Page 6: ToxCast Revisited: A Comprehensive Statistical Analysis of

-

- -

1,224 Chemical >600 In Vitro High 60 In Vivo Endpoints from Structure Throughput Workflow

ToxRef Database Descriptors Screens

5-Fold Cross Validation

8 Classification Algorithms, ~12 Feature Selection

Approaches, 84 Classification Range and Central

Model Combinations Tendency of In Vivo

Predictive Performance Regardless of Statistical

Model Repeat 10X

Partition Data

into 5 Equal

Sets

Set 1 Set

Aside

Select

Features

Build

Model

Predict

Hold Out

Set

Model #1

...

Model #84

Repeat

5X

Aggregate Aggregate No

Based on GO

Category Genes

Based on Aggregation

No

Pre Filter Pre Filter

Page 7: ToxCast Revisited: A Comprehensive Statistical Analysis of

Workflow Details

60 Endpoints x 84 Models x 10 Iterations x 5 Folds = 252,000

separate model fits; computationally intensive.

Predictive models include discriminant, distance scoring, k-nearest

neighbors, logistic regression, general linear model, partial least

squares, partition trees, and radial basis machine.

Various Sets of Predictor Variables:

1. In Vitro Assays, optionally aggregated

2. Chemical Structural Descriptors, computed by Dragon

All endpoints are binary, so performance criteria include: Accuracy,

Balanced Accuracy, Sensitivity, Specificity, Negative Predictive Value

(NPV), Positive Predictive Value (PPV), and Area Under the Curve

(AUC)

Page 8: ToxCast Revisited: A Comprehensive Statistical Analysis of

Predictive Performance Criteria for Binary Endpoints

Prediction Based on In Vitro

Assays or

Chemical

Structure

In Vivo Animal Response

Positive Negative

Positive

Negative

Sensitivity

= TP / (TP + FN)

TP FP

FN TN

PPV

= TP / (TP + FP)

NPV

= TN / (FN + TN)

Specificity

= TN / (FP + TN)

Se

nsitiv

ity

AUC = 0.5

Not Predictive

AUC > 0.5

Predictive

1 - Specificity

Accuracy = (TP + TN)/(TP + FP + FN + TN)

Balanced Accuracy = (Sensitivity + Specificity)/2,

adjusts for prevalence

RMSE = square root (average (true value – predicted

probability)2)

AUC is area under the Receiver Operating

Characteristic (ROC) curve; it measures sorting

efficiency and is directly related to the Mann-

Whitney rank-sum statistic; a value of 1

indicates perfect sorting.

Page 9: ToxCast Revisited: A Comprehensive Statistical Analysis of

Prevalence of Positive Chemicals Among Endpoints Should be Kept in Mind

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Page 10: ToxCast Revisited: A Comprehensive Statistical Analysis of

In Vitro Assays

Chemical Structure

Page 11: ToxCast Revisited: A Comprehensive Statistical Analysis of

In Vitro Assays

Chemical Structure

Page 12: ToxCast Revisited: A Comprehensive Statistical Analysis of

In Vitro Assays

Chemical Structure

Page 13: ToxCast Revisited: A Comprehensive Statistical Analysis of

In Vitro Assays

Chemical Structure

Page 14: ToxCast Revisited: A Comprehensive Statistical Analysis of

In Vitro Assays

Chemical Structure

Page 15: ToxCast Revisited: A Comprehensive Statistical Analysis of

In Vitro Assays

Chemical Structure

Page 16: ToxCast Revisited: A Comprehensive Statistical Analysis of

A. F

req

uen

cy

Fre

qu

en

cy

Fre

qu

en

cy

UQ 0.028 (1.020)

Median -0.078 (0.948)

LQ -0.201 (0.870)

Log2 Ratio Median AUCIn Vitro Assays/ Median AUCChemical Structure Log2 Ratio Median AUCIn Vitro Assays + Chemical Structure/

Median AUCIn Vitro Assays

UQ 0.151(1.110)

Median 0.043 (1.030)

LQ -0.009 (0.994)

UQ 0.023 (1.016)

Median -0.009 (0.994)

LQ -0.053 (0.964)

B.

C.

Log2 Ratio Median AUCIn Vitro Assays + Chemical Structure/Median AUCChemical Structure

Page 17: ToxCast Revisited: A Comprehensive Statistical Analysis of

0.65

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~ c 0.55

! f i 0.5

~

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OA

• • •

OA

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0.45

C_Aet_a.. . _HMdf...-llX.O.W1, Ylii0.1014

o.s o.ss 0.6 0.65 0.7

Chemical Sltuctute Madilll

Chronic Mouse Developmental Rabbit

Chronic Rat Multi-generational Rat

Developmental Rat

Page 18: ToxCast Revisited: A Comprehensive Statistical Analysis of

UQ 0.179 (1.132)

Median 0.075 (1.053)

LQ -0.044 (0.970)

Fre

qu

en

cy

Log2 Ratio Median AUCIn Vitro Assays No Aggregation/ Median

AUCIn Vitro Assays Gene Aggregation

Fre

qu

en

cy

Log2 Ratio Median AUCIn Vitro Assays No Aggregation/ Median

AUCIn Vitro Assays GO Biological Process Aggregation

Fre

qu

en

cy

UQ -0.101 (0.933)

Median -0.155 (0.898)

LQ -0.197 (0.873)

UQ 0.109 (1.078)

Median 0.041 (1.029)

LQ -0.023 (0.985)

A. B.

C.

Log2 Ratio Median AUCIn Vitro Assays No Pre-Filter/ Median AUCIn Vitro Assays With Pre-Filter

Fig. 12

Page 19: ToxCast Revisited: A Comprehensive Statistical Analysis of

Predictability

Mean

(Log2(1/RMSE))

Positive

Prediction

Negative

Prediction

Page 20: ToxCast Revisited: A Comprehensive Statistical Analysis of

Mean

(Log2(1/RMSE))

Positive

Prediction

Negative

Prediction

Page 21: ToxCast Revisited: A Comprehensive Statistical Analysis of

Learning Curves

An appropriate way to assess adequacy of sample size in a

predictive modeling context

Completely different from classic power and sample size

calculations, which are designed for hypothesis testing, not

predictive modeling

Constructed by taking subsets of different sizes and performing

cross-validation model comparison on each, then plot results with

sample size as the x-axis

An upward trend indicates that results would likely improve with

more samples; a flat curve indicates otherwise.

Page 22: ToxCast Revisited: A Comprehensive Statistical Analysis of

CHR_Rat_CholinesteraseInhibition Best model from CVMC = PT_075 (AUC = 0.75583) Worst model from CVMC = KNN_036 (AUC = 0.61631)

0.5

0.55

0.6

0.65

0.7

0.75

0.8

0.85

0.9

0.95

1

Ave

rage

Accu

racy T

est

Se

t

0 50 100 150 200

Training Set Size

Average Accuracy PT_075

KNN_036

Page 23: ToxCast Revisited: A Comprehensive Statistical Analysis of

MGR_Rat_ReproductiveOutcome Best model from CVMC = GLM_025 (AUC = 0.54170) Worst model from CVMC = PLS_057 (AUC = 0.49296)

0.2

0.25

0.3

0.35

0.4

0.45

0.5

0.55

0.6

0.65

0.7

0.75

0.8

0.85

0.9

Ave

rage

Accu

racy T

est

Se

t

0 50 100 150 200

Training Set Size

Average Accuracy

GLM_025 PLS_057

Page 24: ToxCast Revisited: A Comprehensive Statistical Analysis of

0.5

0.55

0.6

0.65

0.7

0.75

0.8

0.85

0.9

0.95

Ave

rage

Accu

racy T

est

Se

t

0 50 100 150 200

Training Set Size

MGR_Rat_Testis Best model from CVMC = PT_074_025 (AUC = 0.50620) Worst model from CVMC = GLM_020 (AUC = 0.44754)

Average Accuracy PT_074

GLM_020

Page 25: ToxCast Revisited: A Comprehensive Statistical Analysis of

Summary •

The current ToxCast in vitro high-throughput screening assays provide

somewhat limited ability to predict in vivo toxic responses.

Sensitivity and specificity of the in vitro assays is related to the balance

of positive and negative chemicals, but even for balanced endpoints,

the overall predictive performance is relatively low.

The in vitro assays provide somewhat lower predictive performance

than chemical structure.

Aggregating the assays based on gene and biological processes did

not appear to improve predictive performance.

Pre-filtering the in vitro assay data, as has been done in previous

studies, can significantly bias estimates of cross-validation performance

in an optimistic direction.

Analysis of predictability and learning curves can help in prioritizing

chemicals for further study and in assessing adequacy of sample sizes.