Clinical Data Management

DH308: NIRMAL PUNJABI
DH 308 – Class 2
06th January 2023
Clinical Data
Management
- Nirmal Punjabi, Ph.D.
Welcome to the course. We will start at 11:05 am.

Today’s Agenda (Class 2)

• Revisit Class 1 Class 2:
• Introduction to Clinical Data • Background
Management • Clinical Trials
• Course Logistics • Types
• Purpose
• Time line
• Size of the cohort
• Control
• Some Terms
• Examples
• Vital Parameters
10-01-2023 2
Introduction to
Clinical Data Management
Etymology of Course Name
CLINICAL DATA MANAGEMENT
10-01-2023 4
Introduction to Clinical Data Management
“Management of Clinical Data”

Clinical Data Management= Clinical Data + Data Management
5
10-01-2023 Image Ref: https://ocrc.net/; Wikipedia ‘Data’; https://trendythingy.in/
Clinical Data
Sources, Types, Significance
Clinical Data
• Data generated from Clinical Research/Studies/Trials
• Clinical Research
• Patient-oriented research
10-01-2023 Source: US FDA 7

Clinical Research
• To understand the effect of drug
/ medicine / vaccine
• New
• Repurposing
• To check the effectiveness of

medical device.
• Diagnosis
• Treatment
• Functional
10-01-2023 8
Image Reference: Volkmann et al, 2020. https://doi.org/10.1371/journal.pone.0241497; https://neuralink.com/approach/
Clinical Research
• Validation of diagnostic tests
• To understand the mechanism

of disease progression.
10-01-2023 Image Reference: https://breathonix.com/; : Hosseini et al, DOI: https://doi.org/10.1016/j.virol.2020.08.011 Virology, 2020 9
Clinical Research
• Preclinical (in vitro)
• Preclinical (in vivo)
• Clinical Trials
• Exclusions:
• Only on tissues/organ in vitro and
without mapping it to patient.
10-01-2023 10
Image Reference: Dobrovolskaia, 2013; https://doi.org/10.1016/j.jconrel.2013.05.025
Clinical Trials (Phases)
10-01-2023 11
Image Reference: https://lupustrials.org/about-trials/phases-of-a-trial/
Examples of Clinical Trials
• WHO's Solidarity Plus trial

• 52 countries involved (as
of 2nd January 2023)
• 14200 hospitalized
patients
• 600 hospitals
• 2000 researchers
• Total : 7 drugs (4
repurposed & 3 now)
10-01-2023 Image Reference: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-

for-covid-19-treatments
12
Examples of Clinical Trials

• Recovery Trial
• 48348 Participants (as of 3rd January 2023)
• 200 sites in UK & some international sites
• Testing treatments for COVID-19 and Influenza
• The RECOVERY Trial is registered at ISRCTN50189673

• EU Clinical Trials Register: EudraCT 2020-001113-21
• Clinical Trials.gov: NCT04381936
• Randomised, Embedded, Multifactorial Adaptive Platform Trial for

Community-Acquired Pneumonia (REMAP-CAP; NCT02735707)
• 10000 participants (estimated as on 3rd January 2023)
10-01-2023 13
Clinical Data Types/Sources

Basic
Parameters
Other
Clinical
Pathology
medical
instruments
Data Tests
Source
Medical
Imaging
10-01-2023 14
Conventional: Case Report Forms (Paper

forms)
10-01-2023 Image Reference: https://stoptb.org/wg/new_diagnostics/assets/documents/case-report-form.pdf 15

Challenges with Clinical Data

• Large data sets
• Interdependent parameters
• Confounding factors
10-01-2023 Image Reference: https://www.theverge.com/2020/10/5/21502141/uk-missing-coronavirus-cases-excel-spreadsheet-error 16

Challenges with Clinical Data

• Large data sets
• Interdependent parameters
• Confounding factors
• Long life cycle
10-01-2023 Image Reference: https://pubmed.ncbi.nlm.nih.gov/32450107/ 17

Generation / Collection
Representation
Formatting
Documentation
Data Quality Control
Life-Cycle Transformation
Access and sharing
Security & Back-up
Archiving
10-01-2023 18

Clinical Data + Data Management
10-01-2023 19

• Data Planning
• Case report form (CRF) design,
• Clinical trials database design and programming
• Data standards,
• Data acquisition,
• Data integration into the clinical trials database,
• Data review for quality control
• Database creation and maintenance
• Regulations
• Audit trails
10-01-2023 20
10-01-2023 21
Image Reference: https://www.healthcatalyst.com/insights/5-reasons-healthcare-data-is-difficult-to-measure
Standard Tools for Clinical Research Data

Capture
10-01-2023 22
Objective of the course

• Overview of the domain of Clinical Data Management
• Why is it needed?
• Where is it applicable?
• Provide understanding of the process of Clinical Data Management

• Study Startup
• Study Conduct
• Study Close Out
10-01-2023 23
Course Contents
• Background: Clinical Trials, Technical Terms, Medical Data Types
• Different Domains
Section 1 • Clinical Trials
• Medical Terms
• Study Start up - Data Planning: Hypothesis, Validated Instruments, CRF • Planning
design, eCRF design, Defining codes/rules, SOPs; Building / selecting
Section 2 databases, Testing Databases • Research Planning
• Human Factors Design
• Study Conduct: Data retrieving, Data cleaning, Documentation of Adverse • Protocols
events,
Section 3 • Error mitigation
• Database selection
• Study Close Out: Data validation & lock, Send for Analysis
• Data-types
Section 4 • Regulations in Practice
• HIPAA
• Future application: Role of AI/ML in clinical trials
• CFR 21, 11
Section 5 • Bio-statistics
10-01-2023 24
Pre-requisites
• None
• Ready to catch up with new jargons across domains
• Data collection tools/forms
• Good to know:
• Basic understanding of common health parameters (Blood pressure, Heart
rate, etc.)
• Basic understanding of medical data from X-Ray, CT scan, ECG,
10-01-2023 25
Grading system *
• Assignments (Individual): 15 % • For Audit:
• ≥ 50% score in Assignments, Quiz,
• Quiz: 10 % Course Project, and Mid-Sem
• Course Project/Group Assignment: • End-Sem is optional
20 %
• Mid-Sem: 25%
• End-Sem: 30 %
• Attendance/Class interaction
• Attendance/Class interaction (expected): ≥ 70%
(expected): ≥ 70%
10-01-2023 26
* Tentative
Microsoft Teams for communication

• For Assignments / Online class / Discussions / Updates
• Teams code to join ‘DH308 Clinical Data Management 2023’
Code: tee4jwj
10-01-2023 27
Class Schedule for January

• Wednesday and Friday: 11:05am to 12:30 pm
• Exception:
• 20th January (Friday) : No class
• 21st January (Saturday): 11:05 am to 12:30 pm.
10-01-2023 28
Discussion / Doubts / Ideas / Feedback session

• Every Alternate Saturday from 11 am to 12 noon
• Optional & Online on Teams
• Schedule for January

• 7th January 2023 (Tomorrow)
• 28th January 2023
• In-person meeting:
• E-mail me (npunjabi@iitb.ac.in) to schedule.
• Schedule for January:
• 7th January
10-01-2023 • 21st January 29
Clinical Trials
Background: Phases, Types, ….
10-01-2023 30
Clinical Trials
• Research involving human subjects.
• “A prospectively planned experiment for the purpose of evaluating
potentially beneficial therapies or treatments”
• Any research:
• that prospectively assigns participants/groups (humans),
• to one or more health related interventions,
• to evaluate the effect on health outcomes.
10-01-2023 31
Clinical Trials (…)
• Types
• Observative
• Prospective
• Retrospective
• Intervention
• New treatment/medicine/
• New medical device
10-01-2023 32
Clinical Trials
• Controlled Conditions
• Participants
• Age Group
• Sex
• Ethnicity
• Present Health Status
• Diet
• Medical History
10-01-2023 33
Clinical Trials
• Site / Location
• Environmental
conditions
• Types:
• Single Site
• Multi-Site
• Hospitals
• Regional
• State
• Country
10-01-2023 34
Clinical Trials
• Intervention /Therapy
• Investigational Drug
• Control
• Gold standard /
Conventional
• Placebo
10-01-2023 Image Reference: Volkmann et al, 2020. https://doi.org/10.1371/journal.pone.0241497; 35

Types of Study Designs
1. Observational Designs
1. Experimental Designs – interventional studies

1. Observational Designs
Types of Observational Studies

• Cohort Studies
• A group of subjects followed over time
• Purpose: defining the incidence and investigating potential causes of a
condition (incidence)
• Can be prospective – investigator chooses a sample group and measures
characteristics in each subject over a period of time that might predict
outcomes
• Can be retrospective – same as prospective, except all data collection and
follow-up has happened in the past; only possible if adequate data is available

• Cross-Sectional Studies
• Similar to cohort studies except all the measurements are made at one time
point with no follow-up
• Purpose: describing variables and their distribution patterns (prevalence)
• Strength – fast and inexpensive since there is no follow-up or waiting time for
outcome

• Case-Control Studies
• Two groups of people examined for the same outcome
• Group 1 – “cases” or a population of people with a certain disease
• Group 2 – “controls” or a population of people without that same disease
• Purpose: compare prevalence of risk factor(s) in subjects with the disease
(cases) versus subjects without the disease (controls)
1. Experimental Designs
Experimental Studies
• These studies evaluate the effects of an intervention
• Types of interventions:
• Behavior modification (eg. a walking program to improve weight loss)
• Drug (eg. a new investigational drug or studying a drug for off-label use – subject to FDA
regulations)
• Device (eg. a new investigational stent – subject to FDA regulations)
• Strength: Can demonstrate causality
Phases of Experimental Studies

Phases of Experimental Studies

• Phase – 0
• First in human trial.
• Purpose is to streamline drug approval process.
• Target/biomarker analytical assays.
• Limited number of subjects (n < 15).
• Exposure to low & non‐toxic doses of the drug for a limited duration (≤ 7 days)
• Provide human PK/PD data.
• Pharmacokinetic : Absorption, Distribution, Metabolism, and excretion
• Pharmacodynamic: Biological processes respond to impacted by drug
• No therapeutic benefit to the participants.

Clinical Data Management - Class 2

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Clinical Data Management - Class 2

Uploaded by

Copyright:

Available Formats

DH308: NIRMAL PUNJABI

Welcome to the course. We will start at 11:05 am.

Today’s Agenda (Class 2)

Etymology of Course Name

Introduction to Clinical Data Management