DH308: NIRMAL PUNJABI

DH 308 – Class 6
21st 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 6)

• Revisit Class 5 Class 6:
• Clinical Trial • Clinical Data Management
• Websites
• Clinical Data Planning
• Clinical Data Management
• Study Startup
• Clinical Data Planning

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DH308: NIRMAL PUNJABI

Clinical Data
Planning
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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 DH308: NIRMAL PUNJABI

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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
• 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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 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 (Wide interests)
• Novel
• Generates new solutions
• Confirms, refutes or extends previous findings
• Address Knowledge Gaps
• Ethical
• Accordance to applicable ethical guidelines
• Relevant
• To scientific knowledge, clinical and health policy, future research
• Practical consideration
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Reference: Farrugia et al, 2010
 Clinical Data Planning: Perspective
Similarity of Clinical Trial to Experiment

Results &
Background Aim/Objective Background Methods/Setup Observation Conclusion
Discussion

Research • Hypothesis • Associated • Tools • Data • Verification • Reporting

Topic Literature required generated • Feedback • Next step
• Outcomes • Reference • Samples • Analysis
methods required
• Conditions
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 Clinical Data Planning
Source of Clinical Research Theme/Idea Source of Clinical Research Theme/Idea
• Documented Information • Individual Clinical Experience
• Scientific Literature Review
• Available information of human body, • Patient Questions
disease, drugs,… • Lifestyle based
• Derived the problem using information and
common sense
• Missing information
• Contradicting studies • Traditional Knowledge
• Media / Blogs • Historically reported observation
• Observation, Claims
• Hearsay, Rumors, Rare events, Unknown • Ayurveda, Yoga, ….
science • Emergency situations like war, ship travel,
• Contemporary issues
etc.
• Individual Clinical Experience • Non-reported but known/practiced
• Expert Opinion
• Experience + Observation
• Lifestyle of Communities
• Non-conforming/conflicting observation • Tribal community
• Compared to the perceived notion • Regional
• Demographic / Ethnicity 11
 Clinical Data Planning
Hypothesis : PICOT
• Population
• Target patient population?
• Intervention
• Investigational intervention like drug/device/therapy
• Comparison Group
• Existing methods, control population, …
• Outcome
• Key parameter that will affected
• Time
• Duration of study
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Reference: Farrugia et al, 2010
 Clinical Data Planning
Hypothesis : PICOT
• Examples
• Dexamethasone is useful in covid-19 patients.

• Dexamethasone is as an effective treatment to improve oxygen saturation

levels in hospitalized covid-19 positive patients.

• Dexamethasone is as an effective treatment compared to placebo to

improve oxygen saturation levels in hospitalized covid-19 positive patients.

• Dexamethasone is more effective than placebo as an adjuvant treatment to

improve oxygen saturation levels within 14 days in hospitalized covid-19
positive adult patients who have had curative treatment for cancer.

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 Clinical Data Planning
Hypothesis OR Research Question
• PICOT is applicable to both.
• Hypothesis is statement
• Research Question is a question?

• Example:
• Is Dexamethasone more effective than placebo as an adjuvant treatment to improve
oxygen saturation levels within 14 days in hospitalized covid-19 positive patients who
have had curative treatment for cancer?
• Dexamethasone is more effective than placebo as an adjuvant treatment to improve
oxygen saturation levels within 14 days in hospitalized covid-19 positive patients who
have had curative treatment for cancer.

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 Clinical Data Planning
Practical Scenario:
• Literature will have mix of Hypothesis or Research Question
• Many literature will not completely follow the PICOT rule.
• PICO is seen in many literature
• PIO is also observed.
• ‘C’ is assumed to be placebo or standard care

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 Clinical Data Planning
What all should be planned? & Dependencies

• Research • Technical Details

Theme/Hypothesis/Clinical • Outcomes
Trial • Dosing Type
• Budget
• Methods
• Regulation
• Ethical Clearance • Parameters
• Historical
• Baseline
• Type of Trial • Monitored
• Randomization ??
• Blinded ??
• Multi-Centre ??
• …..
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 Clinical Data Planning
• Selection of parameters for the study
• ‘Protocol’
• Experimental Plan

• Statistical Analysis Plan

• Methods

• Regulatory requirements
• Country specific
• Protection of patient identity
• Standard format for storage of data

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 Basics
Diabetes
• Problems with glucose
management

21-01-2023 Image Reference: Pearson Education 18

 Basics
Diabetes
• Diabetes Types
• Type I
• No insulin produced by the body
• Prevalent: 5 to 10%
• Medication: Requires Insulin

• Type II
• Insulin is less or ineffective (resistant)
• Prevalent: 90 to 95%
• Medication: Insulin + Medicines

• Gestational Diabetes
• Developed during pregnancy

21-01-2023 Image Reference: https://www.integrativebodyworkeducation.com/post/seeing-past-the-wound-man 19

 Basics

Diabetes
• Need for regular monitoring
• Track the glucose changes
with activity
• Meals
• Lifestyle
• Medicine Intake
• Improve Treatment
• Optimize Insulin / medicine
dose
• Reduce/Delay Complications
• Loss of vision
• Kidney failure
• Amputation
• …….

21-01-2023 Image Reference: https://cmsw.mit.edu/stephen-truong-diabetes-when-going-bathroom-becomes-scary/; https://apdp.pt/clinica/consultas/bombas-de-insulina/; 20

https://revistadiabetespr.com/2021-centenario-del-descubrimiento-de-la-insulina/
 Basics
Diabetes
• What can be monitored?
• Blood Glucose
• Glycosylated hemoglobin
• Glucose in interstitial fluid

Image Reference: http://www.xlab.ro/en/Glycosylated-hemoglobin-assay/; Fig 15.9 from Essentials of Human Anatomy & Physiology, 13th Edition, Elaine N. Marieb and 21
21-01-2023 Suzanne M. Keller
 Basics
Diabetes
• What can be monitored?
• Blood Glucose
✓ Gold Standard
× Pricking: Pain / Swelling
• Glycosylated hemoglobin
✓ Average blood glucose levels
over 3 months
× Averaging: No data of short
term
× Not reliable: Anemia,
Pregnancy and blood disorders

• Glucose in interstitial fluid

✓ Helps in continuous monitoring
× Needs basic calibration with
blood glucose levels

21-01-2023 Image Reference: https://pubmed.ncbi.nlm.nih.gov/33389957/ 22

 Clinical Data Planning
What all should be planned? & Dependencies

• Research • Information needed

Theme/Hypothesis/Clinical • Parameters to be measured
Trial • Historical Data
• Budget
• Statistical Analysis Plan
• Regulation
• Parameter to be analyzed
• Ethical Clearance • Format of Data

• Type of Trial • Participants

• Randomization ??
• Informed Consent
• Blinded ??
• Multi-Centre ??
• …..
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