Mastering Clinical Research
Level - 1 (Coming Soon)
Course Content
Day 1
1. Introduction to Clinical Research (1.5 hours)
Objective: To familiarize participants with the basic concepts of clinical research and its importance in evidence-based healthcare.
Topics Covered (40-min)
- Definition of clinical research.
- The role of clinical research in improving patient care and healthcare decision-making: Evidence-based practice.
- Types of clinical research: Descriptive Studies, observational studies, experimental studies, and epidemiological studies
Q & A (20 min): Address and clear any issues about the topic.
Practical Exercise (30-min): Practice exercise with MCQs to identify the basic study design in the scenarios
Basic Study Designs (1.5 hours)
Objective: To give participants a fundamental understanding of different types of clinical study designs and their purposes.
Topics Covered (40-min):
- Review some common terms: Exposure, Outcome, Population, Sample
- Overview of common study designs with examples from literature: cohort studies, case-control studies, cross-sectional studies, and randomized controlled trials (RCTs).
- Strengths and limitations of each study design.
- How to choose the appropriate study design based on the research question.
Q & A (20-min): Address and clear any issues about the topic.
Practical Exercise (30-min): Participants will be asked to match research questions with the appropriate study design and explain their reasoning.
2. Research Ethics (1.5-hours)
Objective: To introduce the ethical principles that govern clinical research and ensure the protection of human subjects.
Topics Covered (40-min):
- Historical background of research ethics (e.g., Nuremberg Code, Belmont Report).
- Principles of research ethics: autonomy, beneficence, non-maleficence, and justice.
- Importance of informed consent: what it is, how it is obtained, and why it is crucial.
- Protection of vulnerable populations (e.g., children, pregnant women, patients with cognitive impairments).
- Ethical approval process through ABHATH.
Q & A (20-min): Address and clear any issues about the topic.
Practical Exercise (30-min): Introduction to ABHATH & Review of the sample consent forms templates.
3. Literature Review and Search (1-hour)
Objective: To teach participants how to search for clinical research articles effectively using databases like PubMed.
Topics Covered (40-min):
- What is a literature review and why it is important?
- Introduction to PubMed: its structure, functionality, and available tools.
- How to develop search strategies: keywords, Boolean operators (AND, OR, NOT), and filters.
- Accessing full-text articles and understanding different types of research papers (reviews, original research, meta-analyses).
Practical Exercise (20-min): Participants will conduct a PubMed search on a specific clinical topic, retrieve relevant articles, and summarize the main findings.
Day 2
1. Introduction to Data Collection (1.5 hours)
Objective: To introduce the importance of accurate data collection in clinical research and the methods used to collect research data.
Topics Covered (40-min):
- The role of data collection in clinical research.
- Types of data: qualitative vs. quantitative.
- Common methods for collecting data: surveys, interviews, electronic health records (EHR), and clinical measurements.
- Best practices for ensuring data accuracy and consistency.
Q & A (20-min): Address and clear any issues about the topic.
Practical Exercise (30-min): Participants will help enlist the items needed to populate a simple data collection form for a hypothetical study and why it is important.
2. Basic Statistics (1 hour 50 min)
Objective: To provide participants with a basic understanding of statistical concepts relevant to clinical research.
Topics Covered (1-hour):
- Introduction to variables: independent vs. dependent variables, categorical vs. continuous data.
- Descriptive statistics: measures of central tendency (mean, median, mode) and variability (range, standard deviation), frequencies and percentages.
- Introduction to graphical methods
- Introduction to statistical significance: understanding p-values and confidence intervals.
- Importance of sample size in clinical studies.
Q & A (20-min): Address and clear any issues about the topic.
Practical Exercise (40-min): Practice exercise with MCQs to assess the concepts learnt (20-min); Table review in research manuscripts- how to read the information.
3. Reading Research Papers (1.5 hours)
Objective: To teach participants how to read and critically appraise clinical research papers.
Topics Covered (40 min):
- Structure of a clinical research paper: abstract, introduction, methods, results, discussion, and conclusion.
- Introduction to Bias in research.
- Key questions to ask when reading a research paper: What was the study design? Were the methods appropriate? What were the main findings?
- How to assess the quality and relevance of a research paper.
Q & A (20-min): Address and clear any issues about the topic.
Practical Exercise (30-min): Participants will be provided with a sample clinical research article and asked to read and identify the key components of the study (e.g., design, methods, results).
4. Conducting a PubMed Search (40-mins)
Objective: To reinforce the concepts learned during the workshop by engaging participants in a hands-on exercise.
Exercise Details:
- Participants will be asked to develop a research question based on a clinical scenario.
- Using PubMed, they will perform a literature search to identify relevant articles.
- They will then retrieve an article and summarize its key findings, focusing on study design, sample size, and main outcomes.
- Participants will present their findings to the group, explaining how the article contributes to answering the clinical question.
Duration: 2 Days
Instructor: Dr Hina Akram
Target Audience: Healthcare professionals with little or no research experience
Focus: Fundamental concepts and research skills
Start Date: To be decided