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Clinical Trials: An Introduction

Author: Sarah Kenyon and Rachel Hughes



Time: ~2 class periods
Preparation
Time:
0.5-1.5hrs
Search internet for relevant articles
Photocopy materials (Skin Cancer Articles)
Make quiz transparency
Reserve computer room
Materials: Asthma Study Overhead
Clinical Trial Question Sheet
Articles on research on skin cancer
Internet access for students

 


Abstract
In this engage lesson, students will be introduced to clinical trials via a scenario and will begin to read articles about clinical studies associated with skin cancer. As they read, students will identify questions and terms that they are unfamiliar with and if these questions and terms are known, will aid to their understanding. During the subsequent lesson they will address these questions and terms. As a class, they will get a fuller picture of the current state of knowledge about skin cancer, its prevention, and its causes. Students will extrapolate from their articles to make educated guesses about inclusion and exclusion criteria, controls, and identify other important elements of animal and clinical trials.


Objectives
Students will:
1. Identify the major steps in clinical trials
2. Articulate why clinical trials are conducted
3. Develop questions based on a reading about skin cancer and clinical studies.

National Science Standards
Content Standard A: Scientific Inquiry
Identify questions that guide scientific inquiry
Content Standard C: Life Sciences
The Cell
Content Standard E: Science and Technology
Communicate the problem, process, and solution
Content Standard F: Science in Personal and Social Perspectives
Personal and community health
Natural and human-induced hazards
Science and Technology in local, national and global challenges

Teacher Background
This lesson begins with a short lesson for the students about the steps of a clinical trial. The following site: http://www.webmd.com/content/pages/13/65814.htm?z=1104_08950_8900_ct_01 is helpful for understanding what clinical trials are, and has attached pages for different issues and questions.

The site http://www.clinicaltrials.gov/ is a good place to begin to learn about any aspect of clinical trials you are interested in. There are a number of specific terms that you should be familiar with to help lead a discussion with your students.
When performing a clinical trial, researchers must determine who can be part of the study. This is determined by identifying inclusion and exclusion criteria. The webMD site informs us that:

Inclusion criteria are those characteristics that everyone must have to join the trial. For example, in a study of a medication for people with diabetes, all study participants might need to have diabetes.”
and:

Exclusion criteria are those characteristics that people cannot have if they want to join the study. For instance, in a study of a medication to prevent heart attacks, people who have already had a heart attack might be excluded.”

To test whether a drug being tested has an affect, a clinical trial may include not only the test drug, but also a population being given a treatment that appears to be the same, but has no active ingredients, for example a sugar pill. This treatment is called a placebo. Other clinical trials may compare different drugs or different doses. Some trials will include the same intervention to all patients. To be an effective test, what specific treatment is provided to a patient is generally randomized and unknown to their doctors and to them.

Enrollment in a clinical trial requires informed consent. Informed consent requires that
1. The patient is provided with detailed information about the purposes and aspects of the research being conducted
2. The possible benefits and risks that treatments might have
3. Consent must be given voluntarily and might be withdrawn at the wish of the participant without giving any reason and without repercussion.

Resource Websites
Origin of clinical trials: http://www.phcentral.org/medical/whoa.html
Clinical Trials: http://www.webmd.com/content/pages/13/65814.htm?z=1104_08950_8900_ct_01
http://www.clinicaltrials.gov/
Possible articles
http://www.nlm.nih.gov/medlineplus/news/fullstory_28626.html
http://www8.utsouthwestern.edu/utsw/cda/dept37389/files/198611.html
http://biology.about.com/library/weekly/aa121699a.htm
http://www.cancer.gov/newscenter/pressreleases/antioxidants
http://uanews.org/cgi-bin/WebObjects/UANews.woa/4/wa/MainStoryDetails?ArticleID=5832
http://www.ehponline.org/members/2000/suppl-1/71-78gasparro/gasparro-full.html
http://www.ivanhoe.com/channels/p_channelstory.cfm?storyid=13418
http://www.saga.co.uk/health_news/article/2232D4ED-5898-47A3-BFEF CAB5E9AEB5EF.asp?bhcp=1
http://www.marketwire.com/mw/release_html_b1?release_id=114480
http://www.medicalnewstoday.com/medicalnews.php?newsid=40464
http://www.ascribe.org/cgi-bin/behold.pl?ascribeid=20060327.064835&time=08%2019%20PST&year=2006&public=1

http://www.emaxhealth.com/51/4883.html
http://www.mailtribune.com/archive/2006/0308/life/stories/01life.htm
http://www.usmedicine.com/dailyNews.cfm?dailyID=273
Sunscreens and clinical studies
http://www.cosmeticsdesign-europe.com/news/ng.asp?n=66723-p-g-anti-ageing-sun-care-glucosamine

 

 

Activity

1. As students enter the classroom, have the following quiz up on an overhead: (The Quiz is available at http://www.webmd.com/content/pages/13/65957.htm?z=1104_08950_8900_ct_22.)

2.Give students 5 minutes to answer the questions on a new page in their notebooks, and also have them write a question that they have about this quiz.

3. Take the quiz off of the overhead and have them take a few minutes to come up with two more questions and have them write these questions down in their notebook as well.

4. Then provide students with the following scenario: You’re in the waiting room at the doctor’s office for your annual check up when you see the following (place overhead for them to see):

Clinical Trial Overhead

Do you have Asthma? The Asthma and Allergy Center of the University of Fantastic Health is seeking volunteers for a study involving a new treatment, approved by the FDA, for allergic asthma. Volunteers should be male or female, ages 16-40, and have asthma requiring treatment within the last year. Participants must be willing to participate in a five month study with clinical visits every three weeks. For further information, call 555-5550 or email abc@fantastichealth.edu . Financial compensation up to $1500 will be provided when volunteers complete the study. Dr. Maria Ruiz, Principal Investigator. Asthma and Allergic Disease Center, University of Fantastic Health.

5. After reading the overhead, tell the students,“Imagine you have asthma. This study sounds interesting, especially if it is something that can help you manage your asthma, plus the idea of $1500 is very appealing. What questions would you have for Dr. Ruiz? What is important to know before you start a study like this?”

6. Explain to the students that this is what is called a clinical trial.

7. Ask for a show of hands about who has never heard the term “clinical trials” before. Of those who did not raise their hands, ask “In what context have you heard the term before?”, “What do you think the term means?”, “Is there only one type of clinical trial?”

8. Using whatever parts of their answers you can, explain that clinical trials are used to test the effectiveness and safety of new procedures and drugs. The trials may test specific treatment regimes (amount of drug, timing/frequency of treatment, etc.) and follow a very specific timeline that is based on results. The following is from: http://www.webmd.com/content/pages/13/65814.htm?z=1104_08950_8900_ct_01, which should be read by the teacher in its entirety to help conduct this lesson effectively.
“ The FDA groups clinical trials into four phases. Each of these different phases addresses a separate research question.

  • Phase I: First, researchers test a new drug or device in about 20-100 healthy volunteers to determine whether it is safe and what side effects it may have. Researchers also study how long the drug stays in the body, which helps them decide what doses to test further. Phase I studies primarily address the question of safety.
  • Phase II: Next, researchers test the new drug or device in about 100-300 people to determine whether or not it works and to learn more about possible side effects. Phase II studies address safety and effectiveness
  • Phase III: Researchers compare the new intervention to current standard therapy to learn whether it offers any advantage. In a Phase III study, several hundred to several thousand people receive the new drug or device. The FDA will only approve drugs that complete Phase III testing. Phase III studies effectiveness.
  • Phase IV: To monitor long-term side effects, effectiveness, and other potential uses, researchers continue to study new interventions after they are approved and in regular use. “Phase IV studies address long term safety and effectiveness.

It is important to realize that this is just the human portion of an experiment. Clinical trials on humans only happen after a good amount of research in preclincal trials has already shown that a given experiment may be effective. Animal trials as well as laboratory studies using cell lines and other non-whole organism methods precede these studies.

9. Ask students why animal trials might be used instead of human trials. Have them list what they see are the pros and cons of animal trials. It is helpful to use a specific example in this case, otherwise students may get stuck on the ethics of animal trials. While this is a very important issue in animal trials, what it doesn’t address is cost/benefit, and the cost/benefit is based on what you can gain from such studies. Try to steer the class towards differences and similarities in animal and human systems. This might be best attempted by asking which they consider to be a better animal model for a study- lizard or mouse- and to explain why.

10. With the class, address the following topics: inclusion and exclusion criteria, placebos, informed consent and control group. Given what they now know about clinical trials what can they say about the example of a study given above? Where on the clinical trial timeline is this study? (The study is most likely a Phase IV as it already has FDA approval)

11. Take 10 minutes to field questions from students. Encourage them to refer to the questions they came up with from the initial quiz.

12. Pass out articles to student groups.

13. Instruct the students to scan/read their articles. What questions do they have about these clinical trials? Do they understand what is being studied? Tell the students that over the next few days they will be exploring the subject of all these clinical trials, the skin. The students are to use the next few days to develop a better understanding about the topic of skin, cancer and UV radiation so that they can describe the particular study that their news article is about.

14. Direct them to reread that article and to write down at least 3 questions that they will need to address in order to better understand their assigned article.

Homework
The students should read their article and write down at least 3 questions that they need to address in order to understand the study they are reading about.

Embedded Assessment
The clinical trial quiz provides a pretest of what students know about clinical trials. Class discussion will provide an opportunity to assess students’ grasp of clinical trials.

 


PULSE is a project of the Community Outreach and Education Program of the Southwest Environmental Health Sciences Center and is funded by:


an
NIH/NCRR award #16260-01A1
The Community Outreach and Education Program is part of the Southwest Environmental Health Sciences Center: an NIEHS Award

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Supported by NIEHS grant # ES06694


1996-2007, The University of Arizona
Last update: November 10, 2009
  Page Content: Rachel Hughes
Web Master: Travis Biazo