2019Pediatric InvestigationOpen access

Clinical research study designs: The essentials

Ambika G. Chidambaram, Maureen B. Josephson

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Abstract

In clinical research, our aim is to design a study which would be able to derive a valid and meaningful scientific conclusion using appropriate statistical methods. The conclusions derived from a research study can either improve health care or result in inadvertent harm to patients. Hence, this requires a well-designed clinical research study that rests on a strong foundation of a detailed methodology and governed by ethical clinical principles. The purpose of this review is to provide the readers an overview of the basic study designs and its applicability in clinical research.

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What this paper is about

In clinical research, our aim is to design a study which would be able to derive a valid and meaningful scientific conclusion using appropriate statistical methods. The conclusions derived from a research study can either improve health care or result in inadvertent harm to patients. Hence, this requires a well-designed clinical research study that rests on a strong foundation of a detailed methodology and governed by ethical clinical principles. The purpose of this review is to provide the readers an overview of the basic study designs and its applicability in clinical research.

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Available abstract

In clinical research, our aim is to design a study which would be able to derive a valid and meaningful scientific conclusion using appropriate statistical methods. The conclusions derived from a research study can either improve health care or result in inadvertent harm to patients. Hence, this requires a well-designed clinical research study that rests on a strong foundation of a detailed methodology and governed by ethical clinical principles. The purpose of this review is to provide the readers an overview of the basic study designs and its applicability in clinical research.

Key concepts: Harm, Management science, Foundation (evidence), Research design, Clinical study design, Clinical research, Computer science, Engineering ethics

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