Mastering Clinical Research
Level - 2 (Coming Soon)
Course Content
Day 1
1. Study Design in Detail (1.5 hours)
Objective: To deepen participants’ understanding of various study designs and how to choose the most appropriate one based on the research question.
Topics Covered (40-min):
- Overview of basic study designs: Cohort, case-control, and randomized controlled trials (RCTs).
- Prospective vs. retrospective studies and their applications.
- Comparing study designs: Strengths and weaknesses of cohort, case-control, and cross-sectional studies.
- Advanced study designs: Nested case-control studies
- Selecting the right study design based on the research question and available resources.
Q & A (20-min): Address and clear any issues about the topic.
Practical Exercise (30-min): Participants will be given clinical research questions and will select the most appropriate study design, justifying their choices.
2. Research Question, Hypothesis, and Objectives (1.5 hours)
Objective: To teach participants how to develop a clear research question, formulate hypotheses, and define measurable objectives.
Topics Covered (40-min):
- Formulating a research question using the PICO framework (Population, Intervention, Comparison, Outcome).
- Types of research questions: Descriptive, analytical, and exploratory.
- Developing null and alternative hypotheses.
- Writing clear, specific, and measurable research objectives aligned with the research question.
Q & A (20-min): Address and clear any issues about the topic.
Practical Exercise (30-min): Participants will be given a clinical scenario and tasked with developing a research question, hypothesis, and objectives.
3. Sampling Techniques (1.5-hours)
Objective: To familiarize participants with various sampling methods, how to calculate sample size, and minimize sampling bias.
Topics Covered (40-min):
- Introduction to sampling: Importance of appropriate sampling in clinical research.
- Probability sampling methods: Simple random, stratified, cluster sampling.
- Non-probability sampling methods: Convenience sampling, snowball sampling.
- Sample size calculation: Determining sample size and its importance for research validity.
- Minimizing sampling bias: Strategies to ensure representative samples.
Q & A (20-min): Address and clear any issues about the topic.
Practical Exercise (30-min): Practice questions related to sampling.
4. Data Collection Techniques (1.5-hour)
Objective: To introduce advanced techniques for collecting reliable data in clinical research and improving data quality.
Topics Covered (40-min):
- Variables needed for the research
- Use of Databases: Publicly available data
- Survey design: Developing effective questionnaires and the importance of using validated scales.
- Face and Content validation of questionnaires.
- Data collection using electronic health records (EHR): Strengths, limitations, and extraction techniques.
Q & A (20-min): Address and clear any issues about the topic.
Practical Exercise (30-min): Participants will search a data collection tool for a hypothetical study and discuss potential quality issues. Moreover, develop a data collection sheet for hypothetical research.
Day 2
1. Statistical Methods (2 hours)
Objective: To deepen participants’ understanding of statistical methods and introduce advanced tests for analyzing clinical research data.
Topics Covered (1-hour):
- Review of basic Biostatistics: quick snapshot of variable type
- Overview of basic statistical tests assumptions and details of parametric and non-parametric test: t-tests, chi-square, ANOVA, and correlation.
- Introduction to measure of association (OR, RR).
- Understanding and interpreting results of research, p-values and confidence intervals.
- Type 1 & Type 2 errors
Q & A (20-min): Address and clear any issues about the topic.
Practical Exercise (30-min): Participants will review the tables provided from published manuscripts: Discuss tests used, why used and what are the interpretations.
2. Data Management (1 hour)
Objective: To provide participants with tools and techniques for organizing and managing clinical research data.
Topics Covered (40-min):
- Data cleaning: Identifying and correcting data errors, handling missing data, and managing outliers.
- Data coding: How to code categorical and continuous variables for analysis.
- Data organization: best practices for structuring data in spreadsheets or statistical software.
- Creating data dictionaries: Ensuring consistency and documentation of variables
- Checking the distributions: transformation of the data.
Q & A (20-min): Address and clear any issues about the topic.
3. Protocol Development (1.5 hours)
Objective: To guide participants in developing a comprehensive research protocol
Topics Covered (40 min):
- Components of a research protocol: Title, background, objectives, study design, methodology, and timelines.
- Writing study aims and objectives: Creating specific, measurable, and achievable goals.
- Study methodology: Detailing study design, sampling methods, and data collection techniques.
- Ethical considerations: Ensuring informed consent, confidentiality, and IRB approval.
Q & A (20-min): Address and clear any issues about the topic.
Practical Exercise (30-min): Exercise using a hypothetical example relevant to the participant’s areas of expertise.
4. Manuscript Writing, Publication, and Authorship (1 hours)
Objective: To teach participants how to write a research manuscript, submit it for publication, and understand authorship responsibilities.
Topics Covered (40 min):
- Structure of a manuscript: Title, abstract, introduction, methods, results, discussion, and conclusion.
- Writing the introduction: Framing the research problem and providing background.
- Presenting results: Using tables, figures, and charts for data presentation.
- Discussion and conclusion: Interpreting results, addressing limitations, and proposing future directions.
- EQUATOR Reporting guidelines
- Overview of Publication and Authorship
Q & A (20-min): Address and clear any issues about the topic.
Duration: 2 Days
Instructor: Dr Hina Akram
Target Audience: Healthcare professionals with some research experience or those who have completed the beginner-level
Focus: Building on foundational knowledge and introducing more complex concepts
Start Date: To be decided