Activity 3.4.3 Clinical Trials
Introduction
Mike Smith has recovered from his surgery, has completed the last round of his postoperative chemotherapy treatment, and is learning how to use his new prosthetic arm.
Mike is visiting his oncologist today to see where he stands and if further treatment is
necessary. In the last few days, Mike has undergone a variety of tests, including blood
tests, bone scans, MRI’s, and x-rays. The results are in and Mike’s mom is talking to the
doctor in the next room. Although Mike has been feeling better and getting stronger by the
day, he cannot help but worry about the conversation his mom and doctor are having.
Luckily, the door opens, and Mike’s mom walks in with a big smile on her face. The doctor
informs Mike that the cancer is gone. He is in remission and has been given a clean bill of
health. Mike is done with his cancer treatments but will still have to be closely monitored
for signs of recurrence. The oncologist mentions that there is a clinical trial for
osteosarcoma patients recently in remission. The clinical trial is testing a new monitoring
schedule, utilizing regular blood work-ups and radiographic scanning on an outpatient
basis. The oncologist wants to know if Mike would be willing to participate in this clinical
trial.
Even if new medications are deemed safe in laboratory tests, they must be shown to be
safe and effective in humans before doctors can prescribe them to the general public.
Clinical trials are biomedical or health-related research studies that investigate how a new
medicine or treatment works in human beings. In this activity, you will investigate the setup of clinical trials, determine if you would be willing to participate in a clinical trial, as well
as look at the history behind the ethics governing clinical trials.
Equipment
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Computer with Internet access
Activity 3.4.2: Student Resource Sheet
Laboratory journal
Procedure
1. Obtain a Student Resource Sheet from your teacher.
2. Read through the six clinical trial advertisements. For each advertisement, answer the
following questions in your laboratory journal:
o What question(s) are the researchers trying to answer with the study?
o If you met the requirements for this trial, would you consider participating?
Why or why not?
o Would you be interested in the results of this trial? Why or why not?
o What, if any, situation in your life would make you consider enrolling in
this trial? Explain your answer.
o What questions would you want to ask the researchers about the trial?
Why?
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Medical Interventions Activity 3.4.3 Clinical Trials – Page 1
Gina Smith’s five-month-old nephew, Chris, was recently diagnosed with cystic fibrosis. Chris
is not responding well to the current standard treatment. Chris’s doctor has mentioned that
Chris is eligible for a clinical trial investigating a new experimental drug. David and Jackie,
Chris’s parents, want to do what is best for their son. The study is a controlled trial to assess
the efficacy and safety of an inhaled medication among infants with cystic fibrosis. No one will
know if Chris will be receiving the medication being investigated or the placebo, not even the
doctors running the trial.
3. Answer Conclusion question 1.
4. Take notes in your laboratory journal as your teacher goes through the Clinical Trial
presentation.
5. Answer Conclusion questions 2 – 6.
Today, there are strict laws regulating the protection of human subjects, but this has not
always been the case. The history of humans as medical research subjects has been
plagued with stories of human suffering and injustice. Many of the advances in protection for
human subjects were developed in response to cases of human abuse in the name of
scientific research.
Major Cases of Human Abuse and Their Corresponding Legislation/Regulations
Case(s) of Human Abuse:
Nazi Medical Experiments
Legislation/Regulation(s)
Nuremberg Code
Description:
Establishes basic
requirements for human
experimentation. Key Points:
1)Voluntary and informed
consent of participants is
necessary.
2)Experiments must be
scientifically necessary and
conducted by qualified
personnel.
3)The benefit to science must
be weighed against risks and
suffering of human
research subjects.
4)Participants should have
the right to withdraw without
penalty.
Thalidomide Tragedy (1957
to 1961)
1962 Kefauver-Harris
amendments to the Food,
Drug and Cosmetic Act
Dr. Henry K Beecher’s article
FDA Regulation 21 CFR
Empowers the FDA to ban
drug experiments on humans
until the animal trials for the
drug’s safety test have been
completed. Requires
informed consent of human
subjects.
Requires clinical investigators
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Medical Interventions Activity 3.4.3 Clinical Trials – Page 2
“Ethics and Clinical
Research” describing 22
examples of studies with
controversial ethics
Willowbrook Hepatitis Study
130.37 later incorporated in
45 CFR 46
to certify informed consent.
Helsinki Declaration signed
by the U.S. (revised in 1975,
1983, 1989)
Reinforces the principles of
the Nuremberg Code and
added three key points:
1) The interest of the subject
has higher priority than
society.
2) Every subject should get
the best known treatment.
3) Independent review of all
human subject research is
required.
◦ Origin of Institutional
Review Board (IRB)
Public Health Service
Syphilis Study
National Research Act of
1974
Creates the National
Commission for the
Protection of Human
Subjects of Biomedical and
Behavioral Research.
Prompted the establishment
of IRBs at the local level and
required IRB review and
approval of all federally
funded research involving
human participants. (IRB
procedures were
established.)
6. Work with your group to research one major case of human abuse presented in the
above chart and take notes in your laboratory journal. Make sure to include the details
of the case as well as how this case led to ethical reform of clinical trials.
7. Nominate a group leader to give a two-minute presentation of your group’s findings to
the class.
8. Take notes in your laboratory journal as other groups present their findings.
9. Answer the remaining Conclusion questions.
Conclusion
1. What factors need to be taken into consideration when deciding whether or not to
participate in a clinical trial?
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Medical Interventions Activity 3.4.3 Clinical Trials – Page 3
2. Controlled, randomized, double-blind studies are considered the gold standard for
clinical trials. Explain the terms: controlled, randomized, and double-blind. Why are
these so important to the accuracy of a clinical trial?
3. Explain a situation when a double-blind study is not possible.
4. When participating in a controlled clinical study, a participant in the control group is
sometimes given the standard treatment instead of a placebo. Why do you think it is
sometimes unethical to give a participant a placebo?
5. How is a clinical trial set-up similarly to the experimental design?
6. Which cause of human abuse surprised you the most? Explain your answer.
7. Why do you think it took cases of human tragedy before laws and regulations came
into effect protecting the rights of human research subjects?
8. Do you think Mike should participate in the clinical trial for osteosarcoma patients
recently in remission? Explain your reasoning.
9. What would you recommend that David and Jackie do? Explain your reasoning.
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Medical Interventions Activity 3.4.3 Clinical Trials – Page 4