Basics of Clinical Research

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Questions and Answers

What is the definition of Clinical Research?

Any activity designed to test a hypothesis, permit conclusions to be drawn and thereby to develop or contribute to generalizable knowledge only for observational studies.

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to individualized knowledge.

Any activity designed to test a hypothesis, permit conclusions to be drawn and thereby to develop or contribute to generalizable knowledge but only for drug studies. (correct)

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (correct)

What are Good Clinical Practices known as?

Good Research Ethics

Good Study Ethics

Good Research Practices

Good Clinical Practices (GCP's) (correct)

What type of study design involves following a group of subjects over time?

Case-Control Studies

Cohort Studies (correct)

Experimental Designs

Cross-Sectional Studies

What is the purpose of Cross-Sectional Studies?

To describe variables and their distribution patterns. Signup and view all the answers

What is the main difference between Cohort Studies and Cross-Sectional Studies?

Cohort Studies have follow-up while Cross-Sectional Studies do not. Signup and view all the answers

What is the purpose of Case-Control Studies?

To compare the prevalence of risk factor(s) in subjects with the disease versus subjects without the disease. Signup and view all the answers

What are the two groups of people examined in Case-Control Studies?

Cases and Controls Signup and view all the answers

What type of study design involves an intervention or manipulation of a variable?

Experimental Designs Signup and view all the answers

What is the main advantage of Cross-Sectional Studies?

They are fast and inexpensive since there is no follow-up or waiting time for outcome. Signup and view all the answers

What is the scope of Good Clinical Practices?

For all research studies Signup and view all the answers

What is the primary purpose of Phase I studies in experimental design?

To test the safety of a treatment in a small number of healthy volunteers Signup and view all the answers

What is the main difference between observational and experimental studies?

The level of researcher involvement Signup and view all the answers

What is the purpose of a Phase IV study?

To assess the performance of a treatment after it has been approved by the FDA Signup and view all the answers

What is the first step in launching a research project?

Generatng a research idea Signup and view all the answers

What is the primary purpose of a study question in research?

To guide the design of the study and determine the type of study that should be used Signup and view all the answers

What is the PICO component that refers to the group of people being studied?

Population of interest Signup and view all the answers

What type of studies are Phase III studies an example of?

Experimental studies Signup and view all the answers

What is the purpose of a Phase II study?

To test dose ranges and/or efficacy of a treatment in a relatively small number of people with the disease Signup and view all the answers

What is the role of the FDA in experimental studies?

To regulate the use of investigational drugs and devices Signup and view all the answers

What is the purpose of a detailed literature review in launching a research project?

To identify gaps in current knowledge and develop a research question Signup and view all the answers

Study Notes

What is Clinical Research?

Clinical research is a systematic investigation designed to develop or contribute to generalizable knowledge.
It involves research development, testing, and evaluation.

Good Clinical Practices (GCPs)

GCPs are rules and regulations for conducting research.
They provide a standard for the design, conduct, performance, monitoring, analysis, and reporting of research.
GCPs are also known as "Good Research Practices" and dictate the appropriate conduct for all research.

Types of Study Designs

There are two main types of study designs: observational and experimental.

Observational Study Designs

Cohort studies: a group of subjects is followed over time to define the incidence and investigate potential causes of a condition.
Cohort studies can be prospective (investigator chooses a sample group and measures characteristics over time) or retrospective (data collection and follow-up have already happened in the past).
Cross-sectional studies: similar to cohort studies, but all measurements are made at one time point with no follow-up.
Case-control studies: two groups of people are examined for the same outcome to compare the prevalence of risk factors in subjects with and without the disease.

Experimental Study Designs

Experimental studies evaluate the effects of an intervention, such as behavior modification, drugs, or devices.
Types of interventions: behavior modification, drugs, and devices.

Phases of Experimental Studies

Phase I: unblinded studies of a small number of healthy volunteers to test safety of treatment.
Phase II: randomized studies of a relatively small number of people with the disease to test dose ranges and/or efficacy of treatment.
Phase III: randomized studies of a large number of people with the disease to test efficacy of treatment.
Phase IV: large experimental studies or observational studies conducted after treatment has been approved by the FDA to assess performance of treatment (post-market studies).

Steps in Launching a Research Project

Idea: generate a research idea.
Detailed literature review: conduct a thorough review of existing research.
Study question: develop a well-structured clinical research question or hypothesis.
Detailed study protocol: create a detailed plan for the study.
Funding (if needed): secure funding for the study.
Approval: obtain approval from physicians, IRB, and hospital.
Implementation: conduct the study.

Stating the Question/Hypothesis

A research idea should be structured into a well-built clinical research question or hypothesis with PICO components.
PICO components: population of interest, intervention to be tested, comparison strategy, and outcome(s).
The type of question determines the study design that should be used to answer the question.