ONCOLOGY

SDTM, ADAM
DOMAINS
What is
Oncology?
Oncology is the branch of medicine that
researches, identifies and treats cancer. A
physician who works in the field of
oncology is an oncologist.
What is Cancer?
The term “cancer” refers to more than
100 different diseases that begin in
the cells, the body’s basic unit of life.

Benign Tumors
>> Are not cancer.
>> Do not spread to other parts of the
body.
>> Are usually not a threat to life.

Malignant Tumors

>> Are cancer.

>> Have cells that can grow without
control and invade or damage other
parts of the body.
>> When cancer (malignant tumor)
spreads from the original site to
another part of the body it is called
metastasis.
Types of Cancer
>> Solid Tumors

• Carcinomas
• Sarcomas

>> Cancers of the Blood & Bone

Marrow

• Leukemia
• Lymphoma
• Myeloma

Stages
The common stages of cancer are:
• In situ
• Localized
• Regional
• Distant
• Recurrent
• Unknown
Cancer Treatment
The treatment team
• Patient
• Surgeons
• Medical oncologists
• Radiation oncologists
• Nurses
• Others

The treatment plan

• Surgery
• Chemotherapy
• Radiation therapy
• Hormone therapy
• Biological therapy
• Stem cell transplant
• Clinical trial
Local or systemic treatment?

Local treatment affects cancer cells in the tumor

and the area near it
• Surgery
• Radiation therapy
Systemic treatment travels through the
bloodstream reaching cancer cells all over the
body
• Chemotherapy
• Hormone therapy
• Biological therapy
• Targeted therapy
CDISC
CDISC (Clinical Data Interchange Standards
Consortium) has spent the past decade
developing and establishing standards that
facilitate the collection, exchange, reporting
and submission of clinical data along with the
underlying standard terminology.

Why CDISC?
The Submissions Data Standards team of CDISC
prepared the Submission Data
Standards (SDS). SDS is intended to guide the
organization, structure and format of
standard clinical trial tabulation datasets
submitted to a regulatory authority such as
the US Food and Drug Administration (FDA).The
main use of CDISC is portability of data.
This can be done by establishing data standards
and applying them to all the projects.
CONTENT OF DATASETS:
While conducting a clinical trial, clinicians collect
all kinds of patient data. Section K of the FDA’s
Guidance for NDAs describes criteria for CRTs and,
in particular, outlines the contents of datasets
submitted as part of the CRTs. In general, the
following data (grouped on what were formerly
known as CRF domains) should be provided as
individual datasets.

Demographics
Inclusion criteria
Exclusion criteria
Concomitant medication
Medical history
Drug exposure
Disposition
Efficacy results
Human pharmacology and
bioavailability/bioequivalence data
Microbiology data
Adverse Events
Lab – chemistry
Lab – hematology
Lab – urinalysis
ECG
Vital signs
Physical examination
BENEFITS OF CDISC :

>> CDISC standards can significantly improve processes,

thus saving time and cost.
>> Increase data quality.
>> Enable data integration, enhancing re-usability in
‘knowledge’ warehouses to improve science, marketing
and safety surveillance.
>> Streamline data interchange among partners.
>> Facilitate review of regulatory submissions.
>> Enable integration of data from disparate
tools/technologies.

CDISC CAPABILITIES:

The CDISC performs the following checks on domain

content of the source.

>> It verifies that all required variables are present in

the dataset.
>> It reports as an error if any variable in the dataset
that are not defined in the domain.
>> It reports a warning for any expected domain
variables that are not in the dataset.
>> It notes any permitted domain variables that are not
in the dataset.
>> It verifies all domain variables that are of expected
data type and proper length.
>> It detects any domain variable that are assigned a
control terminology specifications by the domain and do
not have a format assign to them.
CDISC DATA MODELS :
CDISC is developing standard data models to support
the electronic acquisition, exchange, submission and
archiving of clinical trial data and metadata (data about
data).

The main CDISC models are as follows:

Operational Data Model (ODM) - Developed to support

the acquisition, interchange and archiving of
operational data

Submission Data Model (SDTM) - Standard metadata

models being developed to support the data flow from
the operational database to regulatory submission.

LAB Model - Covers the exchange of laboratory

information

AdaM Model - Guidelines for the creation of analysis

data sets to ease the FDA statistical review process.

SEND Model - Standard for exchange of non-clinical

data.

CDASH Model – Clinical Data Acquisition Standards

Harmonization.
SDTM (STUDY DATA TABULATION
MODEL):

The CDISC Study Data Tabulation Model

(SDTM) defines the standard format for
tabulation data. Generally, there are three
approaches for implementing SDTM within
the pharmaceutical industry: pure SDTM,
submission-only, and database-only. The
pure SDTM approach means all study data
will be SDTM-compliant, starting from data
capture and ending with data analysis and
submission. The submission-only approach
leaves the current practice alone and
creates the SDTM-complaint datasets for
submissions. The database-only approach
feeds the study data into a clinical
database, which is SDTM-compliant.
ONCOLOGY SPECIFIC
SDTM DOMAINS
The oncology specific SDTM domains
were introduced in SDTMIG v3.1.3 in July
2012. The domains, TU, TR, RS are
intended to represent data collected in
clinical trials where tumors or lymph nodes
are identified at baseline visits and then
repeatedly measured or assessed at
subsequent time points.
TU DOMAIN (Tumor
Identification)
TU domain is used to represent the
identification of the tumor. Tumors are
usually identified in the baseline visit using
some of the methods like MRI Scan, CT
Scan or PET Scan. This information is
mapped into TUMETHOD variable and
anatomic location(TULOC),
Laterality(TULAT), Directionality(TUDIR)
are also mapped into SDTM database.
Each record in the TU domain
corresponds to a unique identification of
the tumor. TUORRES will be used to
capture the result, VISIT variable will be
used to represents the corresponding visit
and TUDTC is used to capture the date on
which the scan in done. The tumor
identified in the baseline is measured at
each subsequent visit and it is captured in
TR domain. In order to link the identified
tumors in TU domain to the corresponding
measurement results in the TR domain,
TULNKID/TRLNKID variable is used.
TR DOMAIN (Tumor Results
Domain)
The quantitative/qualitative assessment
for each tumor identified in the TU domain
is represented in the TR domain at each
subsequent visits. For consistency
purpose, the same method that is used for
the tumor identification is used across all
the visits for tumor measurements. So
Ideally TUMETHOD/TRMETHOD is
similar for a particular lesion throughout
the study.
Since Non Target lesions are not
measurable, a qualitative representation is
used in the result in TR domain. The
representation of TU and TR domain for
Non Target Lesion, Target Lesion and New
Lesion are represented.
RS DOMAIN (Disease
Response Domain)
RS domain contains the information about
response evaluation. This evaluation is
based on all the available information for
that subject and not restricted to TR
domain alone. LB, VS, PE datasets are
also can be used as an input to derive RS
dataset. Variable like RSLNKID,
RSLNKGRP can be used to link the RS
domain with the other domains. RSTEST
and RSTESTCD can be used to
categorize the response assessments like
Target Lesion Response, Non Target
Lesion Response and New Lesion
Response. The response result for each
type of lesion in a particular Visit is
captured in RSORRES variable.
RSLNKGRP variable can be used to
identify the type of lesion in a particular
visit. RSLNKGRP variable is usually
created by concatenating type of lesion
with the corresponding visit number since
the response is not derived based on
Individual lesion. RSCAT usually contains
the standardized response criteria used in
the study.
ADaM (ANALYSIS DATA MODEL):

The CDISC Analysis Data Model (ADaM)

defines a standard for AD’s to be
submitted to the regulatory agency.
Analysis datasets are datasets created
to support results presented in study
reports, ISS, ISE and other analyses
that enable a thorough regulatory
review. Analysis datasets contain both
raw and derived data. The underlying
principle of these models is to provide
clear and unambiguous communication
of the content, source, and quality of
the datasets submitted in support of
the statistical analysis performed by
the sponsor.

.
ONCOLOGY ADaM
Datasets (Time to Event
ADaM datasets)

• ADTR : Tumor Results

Analysis Dataset

• ADRS : Response
Analysis Dataset

• ADTTP : Time to
Progression Analysis
Dataset

• ADPSF : Progression Free

Survival Analysis Dataset
ONCOLOGY ADaM
Datasets (Time to Event
ADaM datasets)

• ADTR : Tumor Results

Analysis Dataset

• ADRS : Response
Analysis Dataset

• ADTTP : Time to
Progression Analysis
Dataset

• ADPSF : Progression Free

Survival Analysis Dataset