Clinical Trials: Experimentation in Medicine?

I recently saw a patient who was interested in participating in a blood pressure clinical trial. Her main apprehension was that her daughter did not want her to be experimented on.

I proceeded to explain to her the typical sequence of events that would have occurred if she consulted me for her blood pressure problem in my medical office:

1. I check my watch before entering the exam room.

2. I calculate 8 minutes to solve the problem; since I am already an hour behind schedule and have 20 unanswered phone calls waiting for me.

3. I check the blood pressure that the nurse took, then listen to her heart and lungs.

4. I run to the drug sample cabinet, select a sample antihypertensive medication, and return to the exam room.

5. I tell her to try the medication, call if she has any problems, and schedule a return visit in one month.

I then explained the sequence of events that would occur in the clinical trial she was interested in :

1. She first reads an informed consent that explains the entire clinical trial, including any risks or potential side effects.

2. After reading the consent, I sit down with her to make sure she understands everything and to answer any questions.

3. She then undergoes a complete medical history, complete physical exam, electrocardiogram, and blood work.

4. After the results of her studies come back, I review them with her and check all the results against the inclusion and exclusion criteria for the clinical trial to make sure it is safe for her to participate.

5. If everything checks out, she is given the clinical trial medication and a follow-up visit is scheduled for one week.

6. She is told to call with any concerns or problems in the interim.

The decision making process in the first scenario takes about 5 minutes. In the second scenario, the patient is evaluated by me and the nursing staff for approximately 2 hours before the decision to administer the blood pressure medication is made.

I left my medical practice years ago to do full-time research so that I could stop experimenting with patients and spend the proper amount of time with them, like I did before managed care changed medicine.