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Related Concept Videos

Observational Studies01:11

Observational Studies

11.3K
Observational studies are a type of analytical study where researchers observe events without any interventions. In other words, the researcher does not influence the response variable or the experiment's outcome.
There are three types of observational studies – Prospective, retrospective, and cross-sectional.
Prospective Study
Prospective studies, also known as longitudinal or cohort studies, are carried out by collecting future data from groups sharing similar characteristics. One...
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Naturalistic Observations02:30

Naturalistic Observations

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If you want to understand how behavior occurs, one of the best ways to gain information is to simply observe the behavior in its natural context. However, people might change their behavior in unexpected ways if they know they are being observed. How do researchers obtain accurate information when people tend to hide their natural behavior? As an example, imagine that your professor asks everyone in your class to raise their hand if they always wash their hands after using the restroom. Chances...
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Data Collection by Observations01:08

Data Collection by Observations

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Data collection refers to a systematic way of obtaining, observing, measuring, and analyzing accurate information. Observational studies are one of the most widely used methods of data collection. It involves collecting data by observing the behavior and physical characteristics of a sample without making any modifications to the sample.
An astronomer viewing the motion and brightness of stars in the sky and recording the data is an example of observational data collection. A botanist recording...
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Study Designs in Epidemiology01:20

Study Designs in Epidemiology

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Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
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Blind Procedures02:07

Blind Procedures

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Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
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Observational Studies Fill a Void Left by RCTs.

Thomas Reinke

    Managed Care (Langhorne, Pa.)
    |January 26, 2017
    PubMed
    Summary

    Observational studies are increasingly used to assess medication safety and effectiveness. Pharmaceutical companies leverage these studies for pricing and formulary negotiations with healthcare payers.

    Area of Science:

    • Pharmacovigilance
    • Health Economics
    • Real-World Evidence

    Background:

    • Growing interest in utilizing observational studies for drug evaluation.
    • Application of real-world data in pharmaceutical value assessment.

    Purpose of the Study:

    • To highlight the increasing use of observational studies in drug development and market access.
    • To underscore the role of these studies in pharmaceutical pricing and reimbursement strategies.

    Main Methods:

    • Analysis of current trends in real-world evidence generation.
    • Review of industry practices in leveraging observational data.

    Main Results:

    • Observational studies are gaining traction for evaluating medication safety and efficacy.

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  • Drug manufacturers are employing these studies to demonstrate drug value to payers.

    • Conclusions:

    • Real-world evidence from observational studies is becoming crucial for market access.
    • These studies influence negotiations on drug pricing, rebates, and formulary placement.