Activity 3.4.3 Clinical Trials

Introduction

Mike Smith has recovered from his surgery, has completed the last round of his post-operative 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 set-up 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

  • 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:
  • What question(s) are the researchers trying to answer with the study?
  • If you met the requirements for this trial, would you consider participating?Why or why not?
  • Would you be interested in the results of this trial?Why or why not?
  • What, if any, situation in your life would make you consider enrolling in this trial? Explain your answer.
  • What questions would you want to ask the researchers about the trial? Why?

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.

  1. Answer Conclusion question 1.
  2. Take notes in your laboratory journal as your teacher goes through the Clinical Trial presentation.
  3. 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: / Legislation/Regulation(s) / Description:
Nazi Medical Experiments / Nuremberg Code / 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)Thebenefit to science must be weighed against risks andsuffering of human researchsubjects.
4)Participants should have the right to withdraw without penalty.
Thalidomide Tragedy(1957 to 1961) / 1962 Kefauver-Harris amendmentsto the Food, Drug and Cosmetic Act / 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.
Dr. Henry K Beecher’s article “Ethics and Clinical Research” describing 22 examples of studies with controversial ethics / FDA Regulation 21 CFR 130.37 later incorporated in 45 CFR 46 / Requires clinical investigators to certify informed consent.
Willowbrook Hepatitis Study / 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.)
  1. 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.
  2. Nominate a group leader to give a two-minute presentationof your group’s findings to the class.
  3. Take notes in your laboratory journal as other groups present their findings.
  4. 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?
  1. 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?
  1. Explain a situation when a double-blind study is not possible.
  1. 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?
  1. How is a clinical trial set-up similarly to the experimental design?
  1. Which cause of human abuse surprised you the most? Explain your answer.
  1. Why do you think it took cases of human tragedy before laws and regulations came into effect protecting the rights of human research subjects?
  1. Do you think Mike should participate in the clinical trial for osteosarcoma patients recently in remission? Explain your reasoning.
  1. What would you recommend that David and Jackie do? Explain your reasoning.

© 2010 Project Lead The Way, Inc.

Medical Interventions Activity 3.4.3 Clinical Trials– Page 1