Question

"Mrs. Wilkins," Dr. Blake said, "I want to ask you to participate in what we call a Phase 1 trial of a new drug called Novamed. The aim of such a trial, it is my duty to tell you, isn't to treat your disease but to help us determine how toxic Novamed is. What we learn may help us figure out how to help other people."

"You mean Novamed won't help me"? Mrs. Wilkins asked.

"I can't say that it won't," Dr. Blake said. "Quite frankly, we just don't know. That possibility is always there, but that's not why you should agree to participate. If you do agree, that is."

"I've been told my disease is terminal," Mrs. Wilkins said. "I'm in the last stage of life right now. So it looks to me like I don't have anything to lose and, potentially, I've got something to gain. It's a gamble, and I'm ready to take it."

"So long as you know Novamed isn't likely to help you," Dr. Blake said. "I'll get the consent forms, and you can ask me any other questions that occur to you."

Now, respond to the following questions:

Should Mrs. Wilkins's consent to participate in a Phase-1 trial be regarded as informed, in your view? Why or why not?

Is Mrs. Wilkins an appropriate candidate for participating in a Phase-1 clinical trial?

How should investigators go about getting people to consent legitimately to Phase-1 trials?

Answer 1

Ans: 1. No, Mr.Wilkin's consent to participate in a Phase-1 trial is regarded as partially informed, but not fully informed. Because, the doctor has clearly mentioned the medicine could or not be effective as well as they are making a test on its toxicity.  The doctor is asking for the consent of the patient. Still the patient is to be informed how long the trial will last, where the trial is being conducted, and how; the risks involved; how the patient safety will be monitored; alternative treatments besides the one being tested in the trial; who is sponsoring the trial; whether the patient has to pay for any part of the trial; the consequences if the patient is harmed by the trial; can the patient opt to remain on the treatment, even after termination of the trial.

Informed consent means that the purpose of the research is explained to them, including what their role would be and how the trial will work.

2. Mr.Wilkins is not a suitable patient for this phase 1 clinical trial as he is not healthy. Phase 1 clinical trials are conducted in a small number of healthy volunteers. This phase may take long time to complete. Here Mr.Wilkins has been told that his disease is terminal. The inclusion criteria for a patient to be a volunteer for the clinical study include age, gender, type and stage of the disease, previous treatment history and other medical conditions.

3. Volunteers should be under the inclusion criteria. Patients considering participating in a clinical trial should talk about it with their physicians and medical caregivers. Potential volunteers should also understand the credentials and experience of the staff and the facility involved in conducting the study. The patient should be answered to questions like

1. How long will the trial last? 2. Where is the trial being conducted? 3. What treatments will be used and how? 4. What is the main purpose of the trial? 5. How will patient safety be monitored? 6. Are there any risks involved? 7. What are the possible benefits? 8. What are the alternative treatments besides the one being tested in the trial? 9. Who is sponsoring the trial? 10. Does he has to pay for any part of the trial? 11. What happens if he is harmed by the trial? 12. Can he opt to remain on this treatment, even after termination of the trial?