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Introduction to Basic Research Methods

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1 Introduction to Basic Research Methods
BST 245 Spring, 2018

2 Course Introduction Write 2 objectives that you might want this course to achieve. Define “research” Define quantitative research Define qualitative research

3 Course Main Objectives
To enhance your ability to read and understand pharmaceutical and related journal articles To learn how to organize, summarize, and display quantitative data To learn how to calculate bio-statistical summary estimates and measures of variability To better understand and learn how to participate in qualitative and quantitative research projects.

4 Research It is a organized process aims at investigating a question in order to find a valid answer that confirms or disputes existing knowledge or generates a new knowledge.

5 Why Research? Basic research helps us learn how our bodies work, and why we get sick. Applied or clinical research generates scientific (pharmaceutical, medical, etc.) evidence to advance our knowledge and treat and/or prevent diseases.

6 Types of Research Research is classified in many different ways (applied, basic, experimental, translational, etc.). In this course we will adopt the broadest classification of research: Quantitative research Qualitative research

7 I. Quantitative Research
In the following we will introduce the basics of quantitative research. Later, we will cover some of the basic aspects of qualitative research.

8 The Research Process Before you start a research study:
Formulate a question and a hypothesis (if needed). Write a proposal to answer the study question and test the hypothesis, if any. Carry out a thorough literature review Determine study design and sample size Obtain an IRB (ethics) approval After you start the research study: Collect and analyze data Produce, interpret and disseminate results Make conclusions and restart the process

9 Results Interpretation
The Research Cycle Questions/ Hypotheses Data Collection Data Analysis Results Interpretation Conclusions

10 Introduction to Study Design
Quantitative research studies are divided into two general categories: Preclinical Clinical

11 Population Sampling Sample Inference

12 Preclinical Research It is an essential step in the process of understanding the complexity and mechanisms of disease. It allows scientists, pharmacists, and clinicians to create models of disease states to uncover the behavioral and cellular processes responsible for the development of disease. Once preclinical research shows a medicine (drug) or treatment to be safe and that it works, the research moves to  the clinical phase.

13 Clinical Research (Trials)
Performed to: Discover best ways to treat or prevent diseases. Test new drugs, vaccines, or medical devices.

14 Food & Drug Administration (FDA)
In the USA, pharmaceutical companies are required to conduct clinical trials to prove to the Food & Drug Administration (FDA) that medications they produce to treat diseases are both safe and effective before they can be sold in pharmacies.

15 Saudi Food & Drug Authority (SFDA)
The main purpose of the SFDA establishment is to regulate, oversee, and control food, drug, medical devices, as well as to set mandatory standard specifications thereof, whether they are imported or locally manufactured. Learn more:

16 Translational Research: Bench to Bed
“Translational research” applies findings from basic science to enhance human health and well-being. It aims to "translate" findings in fundamental research into techniques and tools for treating human disease, i.e., bench to bedside. Accelerating translational research and improving healthcare effectiveness quality are top priorities.

17 References http://www.cebm.net/study-designs/


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