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Chapter 4: Problem 94

Select the best answer The drug manufacturer Merck recently stopped testing a promising new drug to treat depression. It turned out that in a randomized, double-blind trial, a dummy pill did almost as well as the new drug. The fact that many people respond to a dummy treatment is called (a) confounding. (b) non response. (c) comparison. (d) the placebo effect. (e) bias.

Short Answer

Expert verified
The best answer is (d) the placebo effect.

Step by step solution

01

Understanding the Question

The problem describes a situation where a new drug and a dummy pill are being tested in a randomized, double-blind trial. The primary focus of the problem is the phenomenon where the dummy pill (placebo) showed similar results to the new drug.
02

Identifying Key Terms

The key phenomenon here is that a dummy pill produced results similar to the actual drug, which implies a response to the dummy treatment. We need to identify the term used to define this response.
03

Evaluating Multiple-Chance Options

Let's analyze the options: - (a) **Confounding**: Not applicable here as confounding relates to external factors affecting outcomes. - (b) **Non response**: Unrelated because this term involves participants not responding to the survey/questionnaire. - (c) **Comparison**: This is a general term and doesn't specifically address the dummy effect. - (d) **Placebo effect**: This refers to a condition where the patient experiences improvement despite taking a non-active substance, matching the scenario in the problem. - (e) **Bias**: Indicates deviation in results due to systematic errors, irrelevant here.
04

Selecting the Best Answer

The definition in the context of response to a dummy treatment is precisely captured by the "placebo effect", which is option (d).

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Key Concepts

These are the key concepts you need to understand to accurately answer the question.

Randomized Trial
A randomized trial is a scientific experiment that aims to reduce bias and ensure reliable results. Participants are randomly assigned to different groups to compare the effects of a treatment. This random assignment helps to ensure that each group is similar in all significant ways, except for the treatment they receive.

In drug testing, randomized trials are essential for determining a drug's efficacy. They help to eliminate selection bias, meaning that the results will be more representative of the general population.
  • Random assignment ensures each participant has an equal chance of being placed in any group.
  • Randomized trials often involve a control group that receives a placebo or standard treatment.
  • This method helps differentiate between real effects of the drug and those caused by external factors.
Overall, randomized trials are a foundational element of modern clinical research and are instrumental in supporting regulatory approval of new medications.
Double-Blind Study
Double-blind studies are designed to eliminate bias by ensuring that neither the participants nor the experimenters know which group the participants belong to. This is crucial in drug trials to prevent expectations from affecting the results.

In a double-blind study, both participants and researchers are unaware of who receives the real treatment and who receives a placebo. This method helps in several ways:
  • Increases the validity of the results by removing both participant and researcher biases.
  • Ensures that changes in participants' conditions are due to the treatment itself, not other influences like researchers鈥� expectations.
  • Improves objectivity as the data analysts interpret results without preconceived notions.
Double-blind studies are considered the gold standard in clinical trials, especially in trials where subjective assessment of outcomes can affect the results.
Drug Testing
Drug testing involves a series of scientific trials to evaluate the safety, efficacy, and side effects of a new therapy before it reaches the public.

The process is rigorous and can take many years to complete, involving several phases:
  • **Preclinical Testing**: Laboratory and animal testing to assess safety and biological activity.
  • **Phase I Trials**: Focus on safety and dosage in a small group of healthy volunteers.
  • **Phase II Trials**: Examine effectiveness and continue safety assessment in a larger group.
  • **Phase III Trials**: Confirm effectiveness, monitor side effects, and compare with standard treatments in large groups.
  • **Phase IV Trials**: Conducted after a drug is marketed to gather further safety and effectiveness information.
This thorough testing process is crucial to ensure that new drugs are both safe and effective for treating specific conditions.
Statistical Terms
Statistical terms are the backbone of understanding and interpreting data from studies. They provide a framework for decision-making based on the results of experiments.

Some key terms used in contexts like double-blind, randomized clinical trials include:
  • **Placebo Effect**: Improvement seen in patients given a non-active treatment because of belief in the treatment's effectiveness.
  • **Bias**: Systematic errors that can skew results, often minimized by randomization and blinding.
  • **Confounding Variables**: External variables that can affect the results, making it difficult to distinguish between the true effect of the treatment and the effect of these variables.
  • **Non-response**: A phenomenon in which participants' lack of response can affect study outcomes.
Understanding these terms helps interpret the results of clinical trials and can clarify the limitations and strengths of studies involving new treatments.

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Most popular questions from this chapter

Select the best answer Corn variety 1 yielded 140 bushels per acre last year at a research farm. This year, corn variety 2, planted in the same location, yielded only 110 bushels per acre. Unfortunately, we don鈥檛 know whether the difference is due to the superiority of variety 1 or to the effect of this year鈥檚 drought. This is an example of (a) bias. (b) matched pairs design. (c) confounding. (d) the placebo effect. (e) replication.

A corporation employs 2000 male and 500 female engineers. A stratified random sample of 200 male and 50 female engineers gives each engineer 1 chance in 10 to be chosen. This sample design gives every individual in the population the same chance to be chosen for the sample. Is it an SRS? Explain your answer.

A study sought to determine whether the ancient Chinese art of acupuncture could help infertile women become pregnant.41 One hundred sixty healthy women undergoing treatment with artificial insemination were recruited for the study. Half of the subjects were randomly assigned to receive acupuncture treatment 25 minutes before embryo transfer and again 25 minutes after the transfer. The remaining 80 subjects were instructed to lie still for 25 minutes after the embryo transfer. Results: In the acupuncture group, 34 women became pregnant. In the control group, 21 women became pregnant. (a) Describe how the three principles of experimental design were addressed in this study. (b) The difference in the percent of women who became pregnant in the two groups is statistically significant. Explain what this means to someone who knows little statistics. (c) Explain why the placebo effect prevents us from concluding that acupuncture caused the difference in pregnancy rates.

A recent online poll posed the question 鈥淪hould female athletes be paid the same as men for the work they do?鈥欌�� In all, 13,147 (44%) said 鈥淵es,鈥欌�� 15,182 (50%) said 鈥淣o,鈥欌�� and the remaining 1448 said 鈥淒on鈥檛 know.鈥� In spite of the large sample size for this survey, we can鈥檛 trust the result. Why not?

Select the best answer A report in a medical journal notes that the risk of developing Alzheimer鈥檚 disease among subjects who (voluntarily) regularly took the anti-inflammatory drug ibuprofen (the active ingredient in Advil) was about half the risk among those who did not. Is this good evidence that ibuprofen is effective in preventing Alzheimer鈥檚 disease? (a) Yes, because the study was a randomized, comparative experiment. (b) No, because the effect of ibuprofen is confounded with the placebo effect. (c) Yes, because the results were published in a reputable professional journal. (d) No, because this is an observational study. An experiment would be needed to confirm (or not confirm) the observed effect. (e) Yes, because a 50% reduction can鈥檛 happen just by chance.
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