Clinical Trials: Overview

Module Overview

This module uses the concept of clinical trials to teach the scientific method. Students will have the opportunity to guide their own learning through a variety of “learning objects” intended to provide critical thinking about and application of required science standards.

Keywords: blind trial, clinical trial, conclusion, controlled variable, data, dependent variable, experiment, hypothesis, independent variable, placebo, randomization, reliability, scientific method, scientific question, validity, variable

Subject TEKS:

• Scientific Processes All Sciences

  • (2) Scientific investigation and reasoning. The student uses scientific practices during laboratory and field investigations.

• (B) design and implement experimental investigations by making observations, asking well defined questions, formulating testable hypotheses, and using appropriate equipment and technology;

• (C) collect and record data using the International System of Units (SI) and qualitative means such as labeled drawings, writing, and graphic organizers;

• (D) construct tables and graphs, using repeated trials and means, to organize data and identify patterns; and

• (E) analyze data to formulate reasonable explanations, communicate valid conclusions supported by the data, and predict trends.

  • (3) Scientific investigation and reasoning. The student uses critical thinking, scientific reasoning, and problem solving to make informed decisions and knows the contributions of relevant scientists.

    • analyze, evaluate, and critique scientific explanations by using empirical evidence, logical reasoning, and experimental and observational testing, so as to encourage critical thinking by the student;

    • (D) relate the impact of research on scientific thought and society, including the history of science and contributions of scientists as related to the content.

NGSS Science and Engineering Practices

• Ask questions that can be investigated within the scope of the classroom, outdoor environment, and museums and other public facilities with available resources and, when appropriate, frame a hypothesis based on observations and scientific principles.
• Plan an investigation individually and collaboratively, and in the design: identify independent and dependent variables and controls, what tools are needed to do the gathering, how measurements will be recorded, and how many data are needed to support a claim.
• Conduct an investigation and evaluate the experimental design to produce data to serve as the basis for evidence that can meet the goals of the investigation.
• Collect data to produce data to serve as the basis for evidence to answer scientific questions or test design solutions under a range of conditions.

Grades: 6^th – 9^th

Knowledge objectives:

1. Describe the steps in the scientific method.
2. Ask a scientific question that defines a problem.
3. Develop a hypothesis that shows cause and effect, correlation, or comparison.
4. Identify independent, dependent, and controlled variables.
5. Design an experiment that correctly uses variables.
6. Describe a clinical trial.
7. Explain the phases of clinical trials.
8. Compare clinical trials to the scientific method.
9. Contrast reliability and validity.
10. Explain how the research concepts randomization, blind trials, and placebos help prevent bias.
11. Describe how the clinical trials process contribute to the overall cost of pharmaceutical drugs.

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