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New Trials & Findings

Author: Sarah Kenyon and Rachel Hughes



Time: ~2 class periods
Preparation
Time:

Photocopy materials (Skin Cancer Articles)
Reserve computer room

Materials: Clinical Trial Question Sheet
Articles on research on skin cancer
Internet access for students

 


Abstract
Prior to this lesson, students have been introduced to clinical trials and to various aspects of the biology of skin, cancer and the relationship between UV radiation and skin cancer. In this explain lesson, students draw upon their earlier experiences to read and summarize a skin cancer research article and present the findings to their peers. As a class they develop some insight into current research.


Objectives
Students will:
1. Use background knowledge to summarize articles about skin cancer research and present them to the class
2. Place their studies along a clinical study timeline.

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. Students have already reviewed the articles and have identified questions and terms that they have researched during the explore lesson. Now pass out the Clinical Trial Question Sheet. Students will spend the next few days using the information from the engage and explore lessons, and from library research to address the sheet. There are some questions that should be easily answered; others may require more research, depending on the article they are reading. Each group is responsible for answering the questions to the best of their ability, summarizing their article, finding two other references that help them gain a better understanding of what the article is about, and finally, presenting their article and what they have discovered to the class. It is useful to tell students that the questions should act as a guide to finding additional resources.

2. Divide the groups by task- research coordinator, secretary (responsible for the final writing product), presentation coordinator and sheet completion checker. Students should be involved in each stage, but each has their own task completion responsibilities.

3. Allow in-class computer time, and encourage at-home research and discussion.

4. On the final day, have student groups come up one at a time and present their summary to the class. Direct students that as groups present they should be prepared to ask questions, as active student participation on that day will be judged by relevant questions asked by each student. Each student is responsible for asking at least one question, and everyone must either present a portion of their article or field a class-generated question.

5. After student presentations, ask them to write a few paragraphs in their notebooks in response to the question: “What is the reason that clinical trials are so strictly regulated?” or to respond to the statement: “We should just have human trials, animal research is wrong” or another statement or question of your choosing.

Homework
Throughout the week, students will work on their questions, references, and presentations both in class and at home. Each group will also be expected to bring in one current article about their area of study to discuss at the beginning of class.

Embedded Assessment
Through their group topics, teachers can assess the students’ ability to work together to gather appropriate information. Their presentation skills, as well as the ability to listen and respond or appropriately question new material can be assessed during the presentations. In their final responses to the provided statement or question, they will be assessed as to their ability to incorporate the new material in their answer.

 


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


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Last update: November 10, 2009
  Page Content: Rachel Hughes
Web Master: Travis Biazo