Phases of a clinical trial
What is the purpose of a phase I trial?
The first phase tests of a drug in a small group of healthy volunteers. This phase determines if the treatment is safe and how it's distributed in the body.
What is a dependent variable?
The dependent variable is the variable that is measured and expected to change based on the intervention of the independent variable.
This study is looking at the efficacy of a Lyme Disease vaccine vs. placebo in preventing Lyme Disease. How might this trial be funded?
This study is funded by a biopharmaceutical company, Pfizer.
Participants in a vaccine trial don't know whether they received the vaccine or placebo, but the research staff know. This type of blinding is called:
Single Blind!
What is the sample of participants that does not receive the intervention during an experiment?
The Control Group!
What is the purpose of a phase II trial?
Phase II trials test both safety and efficacy. The treatment is given to hundreds of participants to further the research.
What is an independent variable?
The independent variable is the variable that is manipulated or changed by the researcher to see its impact on the dependent variable.
The American Psychological Foundation is one charity that uses philanthropy to advance psychological knowledge into progressive social causes. What are some causes that they might donate too? What types of studies?
The APF promotes studies in ending prejudice and stigma, serving marginalized communities, preventing violence, and addressing mind-body connections.
Dr. Jones is running an experiment to test whether her new drug is effective in relieving anxiety. Her participants are not told whether they have been given the drug or a placebo. The experimental staff who interview the participants after receiving treatment also do not know whether and individual was part of the experimental or control group. This type of blinding is called:
Double Blind!
What is a prediction of how two or more variables are likely related?
A Hypothesis!
What is the purpose of a phase III clinical trial?
Phase three trials focus primarily on efficacy while continuing the collection of adverse events and serious adverse events.
The treatment is given to a large group of participants with the target medical condition. This phase compares the treatment's safety and efficacy to the current standard of care.
What is the process of randomly sorting participants to different groups?
Random Assignment!
This study is looking at attendance of cardiac rehabilitation when incentivized with case management and financial incentives. Participants include those who experience low socioeconomic status. Who might fund this study?
Hint: grant funded
National Institutes of Health, specifically the National Heart, Lung, and Blood Institute within the NIH.
What is the gold standard for blinding in clinical trials?
Double Blinding!
What are the main components of an APA style journal article
title page, abstract, intro, method, results, discussion, references
What is the purpose of a phase IV clinical trial?
During phase four trials the treatment is studied after it's been approved by the FDA. This phase focuses on continuing to study side effects.
What is a correlation?
A correlation is a statistical measure that describes the strength and direction of the relationship between two variables
What does NIH stand for and what types of research do they do?
The National Institutes of Health (NIH) funds medical research to improve health and reduce illness and disability. The NIH is the largest public funder of biomedical and behavioral research in the world.
What is triple blinding?
Although rarely implemented, triple-blind studies occur when group assignment is hidden not only from participants and administrators, but also from those tasked with analyzing the data after the experiment has concluded.
Researchers may expect a certain outcome and analyze the data in different ways until they arrive at the outcome they expected, even if it is merely a result of chance.
What is the process scientists with expertise in a particular subject assess a study before it is published in a scientific journal
Peer Review!
What is a studies phase based on?
The phase of a trial is based on the study's objective, the number of participants, and the current information on the safety and efficacy of an intervention.
What type of variable could you results be attributed to, other than the independent variable?
Confounding Variables!
What is an R01 grant?
An R01 grant is a grant from the National Institutes of Health (NIH) that supports research projects. R01 grants are the most common grant program used by the NIH.
In what situations would researchers unblind a participant before the end of the trial?
Unblinding should occur for the patient's safety when a serious adverse event (SAE) transpires and knowledge of the study drug could dictate the intervention to mitigate the health risk to the participant.
Ex: when a participant experiences anaphylaxis during a vaccine trial.
What is the control group in the following experiment: there is a study examining whether viewing a music video while listening to the song increases a listeners appreciation for the song. Group one listened to the song without watching the music video, Group two watched the video and listened to the song.
Group one!