Scribd
Upload
17 views16 pages

Clinical Research in Surgery

The document outlines the principles and steps of clinical research in surgery, emphasizing the importance of patient-centered outcomes, multidisciplinary collaboration, and ethical conduct. It details a four-step process for conducting research: Define and Organize, Plan, Execute, and Evaluate and Disseminate, along with considerations for validity and ethics. The document also highlights the significance of continuous improvement and collaboration in advancing surgical techniques and patient care.

Uploaded by

shyampandhare7787
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
17 views16 pages

Clinical Research in Surgery

The document outlines the principles and steps of clinical research in surgery, emphasizing the importance of patient-centered outcomes, multidisciplinary collaboration, and ethical conduct. It details a four-step process for conducting research: Define and Organize, Plan, Execute, and Evaluate and Disseminate, along with considerations for validity and ethics. The document also highlights the significance of continuous improvement and collaboration in advancing surgical techniques and patient care.

Uploaded by

shyampandhare7787
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
You are on page 1/ 16

PRINCIPLES AND STEPS OF

CLINICAL RESEARCH IN
SURGERY
Dr Kumar Kaushik
INTRODUCTION
• Clinical research in surgery :
• improves patient outcomes
• advances techniques
• ensures evidence-based practice.
• Requires a systematic approach balancing scientific rigor, ethics, and
patient-centered care.
• Presentation overview:
• Key principles guiding surgical research
• Steps for conducting clinical research in surgery
• Additional considerations for validity and ethics
PRINCIPLES OF CLINICAL RESEARCH
1. Patient-Centered 2. Multidisciplinary
Outcomes Collaboration 3. Ethical Conduct
Focus: Quality of life, Involves: Surgeons, Standards:
functional capacity, relief anesthesiologists, nurses,
• Declaration of Helsinki (
from suffering statisticians, ethicists
website link),
Example: Postoperative Example: Developing
• local regulations
recovery or patient surgical devices or care
satisfaction with minimally pathways "Three Rs" in animal
invasive surgery studies: Reduction,
Refinement, Replacement
PRINCIPLES OF CLINICAL RESEARCH
5. Continuous
4. Evidence-Based Improvement 6. Systematic
Practice (Kaizen) Methodology
Generates sound evidence for Refines processes for future Ensures reliable results via
decision-making studies planning and execution
Example: Efficacy of new Example: Team feedback Example: Randomized
techniques or devices sessions controlled trials (RCTs)
STEPS OF CLINICAL RESEARCH IN
SURGERY
• Four main stages:

• Define and Organize


• Plan
• Execute
• Evaluate and Disseminate

• Each stage includes specific activities for systematic research.


STEP 1: DEFINE AND ORGANIZE
• Establish Research Protocol
• Define question, objectives, methodology
• Example: Laparoscopic vs. open surgery outcomes

• Form Multidisciplinary Team


• Experts: Surgeons, researchers, statisticians
• PI staffs experts into teams

• Define Communication Norms


• Protocols: Meetings, updates

• Secure Funding and Approvals


• Obtain funding and IRB approvals
• Follow Good Clinical Practice (GCP) by International Council of Harmonization
STEP 2: PLAN
• Develop Work Breakdown Structure (WBS)
• Tasks: Ethics approval, patient recruitment, statistical planning

• Create Timeline
• Tools: Gantt charts for milestones

• Plan Data Management


• Protocols: Naming, storage, security
• Example: Secure server with backups
STEP 3: EXECUTE
• Conduct Research
• Follow protocol for procedures/data collection
• Example: Controlled surgical settings

• Track Progress
• Use milestone charts

• Manage Data
• Collect, store, secure data

• Ensure Quality
• Review data for accuracy
STEP 4: EVALUATE AND
DISSEMINATE
• Analyze Data
• Statistical methods for results
• Example: Odds ratios in case-control studies; Hazard Ratios in RCT

• Evaluate Process
• Feedback sessions for improvement

• Publish Findings
• Share in peer-reviewed journals

• Apply Continuous Improvement


• Refine future research
PRECLINICAL STUDIES
• Purpose
• Test techniques/devices on animal models

• Types of Models
• Homologous, isomorphic, predictive

• Ethical Considerations
• "Three Rs": Reduction, Refinement, Replacement

• Regulatory Approval
• FDA approval for clinical trials
CLINICAL TRIALS
• Phases
• Phase 0: Exploratory, few volunteers
• Phase I: Safety, 20-80 volunteers
• Phase II: Efficacy, hundreds of patients
• Phase III: Confirmation, thousands
• Phase IV: Post-marketing surveillance

• Study Designs
• RCTs: Parallel groups, Matched Pairs, Crossover
• Blinding: Single, double, triple
OBSERVATIONAL STUDIES
• Purpose
• Assess outcomes without interventions
• Types
• Case-control, cohort, cross-sectional
• Analysis
• Odds ratios or risk ratios
• Design Considerations
• Stratified sampling for validity
BIAS AND CONFOUNDERS
• Common Biases
• Selection bias
• Detection bias
• Investigator bias
• Mitigation
• Randomization
• Blinding
• Adjustments
• Controlling Confounders
• Matched pairs design
GOOD CLINICAL PRACTICE (GCP)
• Purpose
• Ethical Standards
• Data Reliability
• Participant Protection
• Governance
• ICH Guidelines
• Declaration of Helsinki
• Key Focus
• Rights
• Safety
• Well-being of participants
CONCLUSION
• Clinical research in surgery advances patient care and techniques.
• Guided by patient-centered, ethical, and evidence-based principles.
• Four-step process:
• Define and Organize
• Plan
• Execute
• Evaluate and Disseminate
• Additional considerations ensure validity and ethics.
• Collaboration and improvement are key.

You might also like