Clinical Trial Protocol

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Questions and Answers

What is the primary purpose of a protocol in a Randomized Control Trial (RCT)?

To publish the results of the trial

To prevent bias and reduce errors (correct)

To select the experimental and control groups

To analyze the data collected during the trial

What is the main difference between a pilot study and a full-scale RCT?

Duration of the study

Objective of the study

Sample size (correct)

Type of intervention

What is the reference population in a RCT?

The population that is excluded from the trial

The population that is randomly selected for the trial

The population that participates in the trial

The population to which the trial results are intended to be applicable (correct)

Why is randomization important in a RCT?

To reduce bias and ensure that the groups are comparable Signup and view all the answers

What is the primary criterion for selecting participants in a RCT?

Informed consent of the participant Signup and view all the answers

What is the purpose of a feasibility study?

To test the feasibility of a larger RCT Signup and view all the answers

What is the term for the population that participates in a RCT?

Study population Signup and view all the answers

What is the goal of protocol development in a RCT?

To develop a protocol that outlines the objectives, methods, and procedures of the trial Signup and view all the answers

What is the primary purpose of randomized control trials in epidemiologic experiments?

To assess the effectiveness of new programs or therapies Signup and view all the answers

What is the key difference between randomized and non-randomized control trials?

The method of assigning participants to groups Signup and view all the answers

What is the first step in conducting a randomized control trial?

Drawing up a protocol Signup and view all the answers

What is the purpose of the World Health Organization's (WHO) code of practice in connection with human trials?

To ensure the safety of participants Signup and view all the answers

What is the main advantage of using animals in experimental studies?

They are not subject to the same ethical considerations as human subjects Signup and view all the answers

What is the purpose of the follow-up step in a randomized control trial?

To assess the outcome of the experiment Signup and view all the answers

What is the term for the process of assigning participants to either a reference or experimental group in a randomized control trial?

Randomization Signup and view all the answers

What is the primary goal of an epidemiologic experiment?

To identify the causes of a disease Signup and view all the answers

What is a major challenge in conducting epidemiologic experiments when the disease frequency is low and the natural history is long?

Following up with participants Signup and view all the answers

What is the purpose of allocation concealment in randomized control trials?

To minimize selection bias Signup and view all the answers

What type of bias occurs when there is a lack of blinding in a clinical trial?

Assessment bias Signup and view all the answers

What is the term for non-randomized trials that are used when it is not possible to conduct randomized control trials on humans?

Quasi-experimental study Signup and view all the answers

What is the primary reason why preventive measures can be applied only to groups or communities in some cases?

Administrative problems Signup and view all the answers

What is the term for the practice of dividing experimental subjects or specimens into different intervention groups?

Selection bias Signup and view all the answers

Why are randomized control trials not always possible to conduct on humans?

Due to all of the above Signup and view all the answers

What is the purpose of protocol development in epidemiologic experiments?

To set priorities for the implementation of activities Signup and view all the answers

Study Notes

The Protocol

A crucial feature of any RCT, specifying the study's aims, objectives, and criteria for selection of the study and control groups, sample size, and treatment to be applied.
The protocol aims to prevent bias and reduce sources of error.

Pilot Study

Also known as a feasibility study, conducted on a small sample size to check whether the study is feasible under certain conditions and environment.

Selecting the Reference and Experimental Populations

The reference population is the population to which the study's findings are expected to be applicable.
The experimental population is derived from the reference population and should be randomly chosen from it.

Participants' Criteria

Participants must give informed consent.
They should be representative of the population.
They should be qualified or eligible for the trial.

Randomization

The "heart" of a controlled trial, ensuring the study's integrity.

Experimental Studies

Involve some action, intervention, or manipulation of a variable to observe the outcome.
Aims to provide "scientific proof" of etiological factors and measure the effectiveness of health services.
Can be conducted on animals or human beings.

Types of Experimental Studies

Randomized control trials
Non-randomized control trials (quasi-experimental studies)

Randomized Control Trials

An assessment method for new programs or therapies.
Basic steps include: drawing up a protocol, selecting reference and experimental populations, randomization, manipulation/intervention, follow-up, and assessment of outcome.

Non-Randomized Trials

Conducted due to ethical or administrative problems.
Also called quasi-experimental studies.

Types of Bias

Selection bias: occurs when experimental subjects or specimens are divided into different intervention groups.
Assessment bias: occurs when bias in the assessment of the outcome exists.

Assessment Bias

Also called ascertainment bias, diagnostic bias, or detection bias.
Caused by lack of blinding (triple blinding).

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Description

A protocol is a crucial element of a Randomized Controlled Trial (RCT) that outlines the aims, objectives, and methodology of the study. It ensures that the trial is conducted with minimal bias and error.