DH308: NIRMAL PUNJABI

DH 308 – Class 5
18th January 2023

Clinical Data
Management
- Nirmal Punjabi, Ph.D.

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

 DH308: NIRMAL PUNJABI

Today’s Agenda (Class 5)

• Revisit Class 4 Class 5:
• Clinical Data • Clinical Trial
• Sources
• Websites
• Basic Parameters
• Pathology Data
• Medical Imaging • Clinical Data Management
• Other Instruments
• Clinical Data Plan
• Types
• Qualitative / Quantitative • Study Startup
• Text / Images / Tabular / …

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Clinical Data
Types, Information, Source

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ECG basics: Cardiac Electrophysiology

• ECG

• ECG signal
• Limb Leads
• Einthoven’s Triangle
• Chest Leads

21-01-2023 Image reference: https://link.springer.com/article/10.1007/s10462-021-09999-7; https://geekymedics.com/understanding-an-ecg/; https://ecgwaves.com/topic/ekg-ecg-

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leads-electrodes-systems-limb-chest-precordial/
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Health basics: Cardiovascular

Cardiac disorders
• Important parameters
• Blockage
• Heart muscle damage
• Movements
• Sound

• ECG signal
• Shape

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Image Reference: https://ib.bioninja.com.au/options/option-d-human-physiology/d4-the-heart/electrocardiography.html
 DH308: NIRMAL PUNJABI

Health basics: Cardiovascular

Cardiac disorders
• Important parameters
• Blockage
• Heart muscle
damage
• Movements
• Sound

• ECG signal

21-01-2023 Video Reference: https://giphy.com/gifs/transparent-picture-dump-nRrlFdWcd9cbu;

6 https://www.pond5.com/stock-
footage/item/142677764-cardiac-arrhythmias-ventricular-rhythms-v-tach-vs-v-fib-anim;
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Clinical Data: Data Types …

• Data Types: • Data Types:
• Quantitative • Tabular Data
• Time Series
• Qualitative • Free Text
• Images & Videos

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Clinical Data
Data Types

Qualitative Quantitative

Nominal Ordinal Binary Discrete Continuous

Patient History Number of Hemoglobin

Skin color Pain/Discomfort
(Yes/No) visits level

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Clinical Data Types: Practice

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Reference: https://www.who.int/tdr/diseases/tuberculosis/case-report-form.pdf
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Clinical Data: Data Types …

• Tabular Data • Free Text
• Rows / Columns • Example:
• Dependent and independent • Physician Notes, Radiology
parameters reports
• Multiple variables
• Example:
• Pathology lab reports
• Images and Videos
• Time Series • Gray Scale / Color
• Same variable over different • Example:
time • X-ray / CT /
• Example: • Thermal Image / fMRI
• ECG, EEG, Heart Rate, PPG

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Clinical Data v/s Clinical Outcome

• Clinical/Study Outcome • Clinical/Study Outcome
• Defined important parameter at • Primary
the end-point of the study
• Parameter that will have the • “the planned outcome measure
maximum effect of the that is the most important for
Invervention. evaluating the effect of
an intervention/treatment.”
• Parameter/Event that will be
important to know the • Usually 1 or 2. Can be more.
effectiveness of intervention.
• Secondary
• SHOULD be defined ‘a priori’ • “ a planned outcome measure
that is not as important as the
primary outcome measure for
• Types evaluating the effect of an
• Primary intervention but is still of
• Secondary interest”
• Usually multiple.
21-01-2023 Reference: https://clinicaltrials.gov/ct2/about-studies/glossary; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5790671/ 11
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Clinical Trials Database

• United States of America / US FDA
• https://clinicaltrials.gov/

• India / CDSCO
• https://ctri.nic.in/Clinicaltrials/login.php

• EU
• https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en

• WHO
• https://trialsearch.who.int/

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Clinical Trials Database

• Example of Clinical Trial
• https://clinicaltrials.gov/ct2/show/NCT04707534?term=dexamethasone&cond
=covid&draw=2&rank=1

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Clinical Trials Database

• Example (ctd..)
• https://clinicaltrials.gov/ct2/show/NCT04707534?term=dexamethasone&cond
=covid&draw=2&rank=1

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1
5

Clinical Data
Planning
Why Clinical Data planning?
• Data
• “Data is the new gold” “Data is the new oil”

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Image Reference: qad.com
Clinical Data planning
• Why data should be collected?
• What data will be collected?
• How data will be collected?
• How data will be processed?
• How data will be stored/protected/archived/destroyed?

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Why Clinical Data planning?
• In perspective of clinical trials
• Deciding factor
• Product/therapy: Useful or Junk?
• Regulatory
• Enter different geographies
• Cost Involved
• Investment on clinical trials to generate data
• Marketing
• Promotion
• Legal
• Defense against accusation of credibility

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 Clinical Data Planning
• Individuals involved
• Doctors/Researchers
• Biostatistician
• Clinical Data Manager
• Ethics committee members
• …….

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 Clinical Data Planning
• Begin with the process/end in mind
• What is the aim of the study?
• What factors should be controlled?
• Confounding / Interfering factors

• Real-world challenges
• Limited access to electricity
• Limited access to digital tools
• Error in noting data
• Seasonal effects
• Sharing challenges

• Spend as much time at this step to reduce problems in future.

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 Clinical Data Planning
Clinical Research Theme/Idea : FINER
• Feasible
• Adequate number of subjects
• Affordable in time and money
• Manageable in scope
• Interesting
• Intrigues investigator, peers and community
• Novel
• Confirms, refutes or extends previous findings
• Ethical
• Accordance to ethical guidelines
• Relevant
• To scientific knowledge, clinical and health policy, future research

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Reference: Farrugia et al, 2010