Clinical research methodology introduction

1. clinical research methodology
PART I: INTRODUCTION
Boniface NSENGIYUMVA
August 3, 2017
Rwanda Military Hospital
Clinical Education and Research Division

2. Outlines
Introduction
Study Design
Data Collection
Data Management
Data analysis and interpretation of results
Publication and dissemination Knowledge
Translation
Ethical Principles
Important references
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3. Introduction
⇒ The branch of medical science that determines the safety and
effectiveness of medications, devices, diagnostic products, and
treatments intended for human use; for prevention, treatment,
diagnosis or for relief of symptoms in a disease.
Source: Ximena, P.(2012-2013). Conducta Responsable en la
Investigación, Course Note, Universidad de los Andes, Colombia
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4. Introduction
Clinical research uses scientific methods to answer a precise and
relevant question
Careful reading on existing materials is need for identified topic to
avoid replication
All prior preparations have to be done before the study starts
(study protocol, design, data collection, data analysis,
dissemination and knowledge translation)
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5. Study Design
Identification of the Study Design has to be done before data
collection process
The choice of the study design is guided by the objective to be
achieved
e.g: objective: to study the efficiency of the new treatment
proposed to be used in the treatment of TB. Study design:
Prospective study
Experimental study design: Randomized trial, Cross-over trial,
factorial design, etc
Observational Study design: case-control design, cohort study
design, case series, cross-sectional, etc
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6. Data Collection
Data collection stage is the cornerstone of the study since it
provides the facts to deduct the conclusions wrt to the study
objectives
Qualitative or/and quantitative measures i.e. data on variables are
more important
Data have to be of high quality: Representative sample, blinding,
well designed CRF or questionnaire, relevant endpoints
Primary data collection: CRF, Interview, Questionnaire, FGD, etc
Secondary data collection: stored data on pc, documents, etc
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7. Data Management
This stage is needed to avoid incorrect study conclusions
Data has to be available, complete, consistent, timely, accurate,
reliable, unique, internally and externally valid
Entering the collected data using softwares such as Excel, SPSS,
Access, etc
Data cleaning: Detecting and correcting (or removing) incomplete,
incorrect, inaccurate or irrelevant parts of the data
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8. Data analysis and interpretation of results
use of descriptive data analysis to have insight into data: Mean,
variance, std, quartiles, tables, graphics, etc
The choice of data analysis method is guided by the research
question and the kind of data collected:
OLS (Ordinary Least Squares) method i.e. linear regression is used
for continuous data of the dependent variable
ANOVA is used for continuous dependent variable and categorical
independent variables
Logistic regression is used for discrete data of the dependent
variables
Clustering is used to detect latent group into data
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9. Publication and dissemination
careful review of the research report to be published
Publishing results of research projects enables the scientific
community to evaluate the findings themselves or facilitate
replication if necessary
Publishing research results plays an important role of moving the
science forward while directly or indirectly rewarding authors.
The published findings should reach the targetted audience, in
way to get the expected results. e.g. informing the public about
the recent research findings about STD prevantion i.e. use of
PREPEX and surgical circumcision.
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10. Knowledge Translation
⇒ Assessment, review, and utilization of scientific research.
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11. Ethical Principles
Every researcher has to comply with ethical guidelines that are
well specified in the protocol: Respect of persons, Beneficence
and Justice.
Source:http://adrienneshnier.com/blog/category [Accessed on 31/07/2017]
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12. Questions and comments
Source:http://www.tamuk.edu/finance/fpc/fpc-qcc.html [Accessed on
01/08/2017]
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13. Important References
1. Kothari, C.R., (2004). Research Methodology, Methods and
Techniques. New Delhi: NEW AGE INTERNATIONAL (P) LIMITED,
PUBLISHERS.
2. Rosenbaum, D., (2002). Clinical Research Coordinator Handbook,
GCP Tools and Techniques, 2nd Edition. Boca Raton: CRCPress
3. Knowledge Translation:
http://ktdrr.org/ktlibrary/articles_pubs/ncddrwork/focus/focus10/Focus
[Accessed on 31/07/2017]
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14. ENDOF PRESENTATION
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