I have participated in two drug trials, but now I am concerned

[dm59701]

I have participated in two drug trials both are on diabeties type 2. The first one lasted for about a year and half, it was very hard to control my sugar level and my blood preasure kept climbing.

The one test I am involved in right now was going along great till I started to have blood/white cells show up in my urine. In the past 6 weeks they have drawn 4 samples and every time there are traces. The study Doctor does not seem to concerned but yet the FDA has issued new a warning concerning the kidneys and pancreas. And in fact all participant had to sign new concent to participate forms that covered the FDA warnings.

But know I wonder, I am having hard time finding some one with the study to express my concerns. Since the Doctor seems distracted, unconcerned, distant from my feeling. I have lost confidence in him, his clinic, and there workers.

Basically I am considering quitting the study then finding a new Doctor, then proceed on finding if I was damaged from the study medication. I feel I am in a room with no one listening, no place to help me with my rights but all looking out for the company

[Slipper07]

I'm sorry about your experience, I've never had any issues in the studies that I have participated in, they were all great. You should probably tell the doctor that you want to contact someone from the pharmaceutical company that is sponsoring the study, I think they would be interested in hearing about your concerns.

[snowdog]

Sorry to hear that you feel that way about the study that you are in. But just because the Dr seems distant doesn't mean that you are not getting good care (Some doctors do not have the best bedside manor). You should ask the study doctor why he is not concerned about changes in your lab results. When you participate in a trial the study doctor is not the only one who sees you lab results. The company sponsoring it also carefully evaluates all of your lab results and consults with experts. If they have any significant concerns about your results they will drop you immediately from the study . Also, you can always contact the IRB for the study (they are listed in your consent form). They are on your side and work to protect you as a participant. If you think you are not getting good care you should let them know and the study clinic will be investigated.

[RoseyFuture]

What does your personal Doctor say?
Blood Pressure and other serious health issues are NOT to be taken lightly!
Read the "handwriting on the wall" and STOP before it's too late!
Focus now, not on trials, but on undoing/controlling the damage. It's time to heal, not test.

Unfortunately not all trial sites offer the same level of care. While it is better to be in a study where they are monitoring you regularly and at the sponsor cost, if you are concerned about something then you should follow up with your own physician. If you truly feel that you are not being followed appropriately in the study and you cannot get the attention of the PI or staff then you may go to the sponsor or the IRB. The information should be in your consent form that they are required to give you a copy of.

It is difficult to tell whether the course of the disease caused the problems or whether the study drug did. They may be able to take you off of study drug and see if the problem resolves and later rechallenge to see if it was study drug. Sometimes the sponsor will allow that and other times they won't.

By all means be proactive and get the answers that you seek. It is your health and you are entitled to have your questions and concerns addressed. It is important to the study to be able to capture this information in order to evaluate the safety and effectiveness of the drug.

Good luck!