Clinical research methodology preparations

Clinical Research
Methodology II
Clinical Research Preparations
Boniface NSENGIYUMVA
Researcher−Biostatistician,
Rwanda Military Hospital
December 21, 2017
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Outlines
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Introduction
Study Identification
Research Question
Research Topic
Objectives
Methodology
Scope
Budget
Timeline
Research Protocol
Research Proposal
Concept note
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Why do we carry out clinical research?
 Building Knowledge and Efficient Learning;
 To Find and Seize Opportunities
 To answer questions and generate new
knowledge and practices

Motivating factors for clinical research
 Rewards from research findings and
publication;
 To give back to the community;
 Career development;
 Money and fun.
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Does data collection matter for you?
 Data collection phase 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 of
variables/ indicators are the most important for
research
 Data have to be of high quality: Representative
sample, blinding, well designed and filled
CRF,questionnaire or openclinic;
 Relevant endpoints need to be identified.

Research stages
A study is conducted in 3 stages:
 Study Preparation;
 Collection, organization and analysis of
data;
 Preparation and submission of the research
manuscript;

Study Identification
 Identifying the field within which a study
can be conducted;
 The choice has to be related to the expertize
and interest of researcher;
 Reading as many as possible materials
related to the field of interests to increase
and update the knowledge about it
Example of the field: Nephrology

Research Question
 Identifies the phenomenon to be studied;
 Filling the gap of existing knowledge and
understanding;
 Example: what are causes and treatment of
kidney failure?
”It is more important to science, namely to
formulate problems, to find solutions.” A Einstein

Research Topic
 The topic roughly represents the research
project;
 The topic should be unique;
 May reflect to other research problems;
Example: causes and treatment of kidney
failure at RMH

Objectives
 defines the specific aims of the
study;
 Must clearly be stated;
Example: To identify factors and treatment
of kidney failure

Methodology
 Study Design
 Data type
 Data Collection tools and Methods
 Sample Size
 Data Analysis and interpretation

Scope
Period of the Study
 Specifying the entire period the study will
cover;
 The period of time from which the data will
be collected from
Field of Interest (advantages)
 Managing efforts and resources;
 facilitate ensuring the quality of work;
 Building tough experience

Budget
 Ensures that sufficient resources are
available to complete the research work
to be undertaken.
 It should be based on a full
analysis of expected research
project costs;

Timeline
 Matching objective and available time;
 Small time unit such as week is preferred;
 Regular monitoring of time management is
important to do the study on time

Research Protocol
 It is a detailed set of research activities
proposed to be done
 Those activities should be supported by evidence
from other research accessed during preliminary
investigations
 Main Components: Rationale, study objectives,
methodology, safety consideration, ethics and
informed consent

Research Proposal
 Presenting and justifying the need to solve a
research problem
 Presenting the practical ways the proposed
study should be carried out.
 It includes the key elements involved in the
research process to be undertaken

Concept note
 It is a summary of the research proposal
containing a brief description of the idea of the
research project and the objectives to be
achieved.
 Main components: Title, problem statement,
literature review, objectives, research questions,
methodology, timeline and references

Your intervention
Comments & Questions

END
Thank you for your kind attention!

Clinical research methodology preparations

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