Research vs Standard Medical Care: What's the Difference?
Many clinical trial protocols involve a number of procedures. Some of the procedures are routine for the diagnosis, treatment or monitoring of the disease or condition involved. Those that are not routine, and those that are conducted in a way that is not routine, constitute the research-related (or experimental) procedures. Why are these distinctions between standard (routine) and experimental procedures important?
The first consideration is financial. If you are a patient who is a participant in a clinical trial, your medical insurance will usually cover those procedures that are routine for the disease or condition. Depending upon your insurance plan or the state in which you live, your insurance may or may not pay the expenses associated with the experimental procedures. It is important, then, to determine which procedures your insurance will cover and confirm that those not covered by your insurance will be paid by the clinical trial.
Second, and more importantly, the experimental procedures really represent the risk you will be assuming if you participate in the clinical trial. You will already have to undergo the standard procedures for your condition. By volunteering for the clinical trial, you will be signing up for some additional risks - those associated with the experimental aspects of the study.
Bottom line: If you're considering participating in a clinical trial because of a disease or condition you have, ask about which procedures are standard medical care for the condition and which are experimental.
-Joe
Related Links: Glossary of Terms Used in Clinical Trials, Benefits and Risks
Technorati Tags: Clinical Trials, Experimental, Insurance
The first consideration is financial. If you are a patient who is a participant in a clinical trial, your medical insurance will usually cover those procedures that are routine for the disease or condition. Depending upon your insurance plan or the state in which you live, your insurance may or may not pay the expenses associated with the experimental procedures. It is important, then, to determine which procedures your insurance will cover and confirm that those not covered by your insurance will be paid by the clinical trial.
Second, and more importantly, the experimental procedures really represent the risk you will be assuming if you participate in the clinical trial. You will already have to undergo the standard procedures for your condition. By volunteering for the clinical trial, you will be signing up for some additional risks - those associated with the experimental aspects of the study.
Bottom line: If you're considering participating in a clinical trial because of a disease or condition you have, ask about which procedures are standard medical care for the condition and which are experimental.
-Joe
Related Links: Glossary of Terms Used in Clinical Trials, Benefits and Risks
Technorati Tags: Clinical Trials, Experimental, Insurance
6 Comments:
I've found that clinical trial administrators step over the line with their definition of standard medical care. For example, they may want their own baseline CT scan for the study even though you've had a scan the week before at another institution. Sure, a CT scan is standard treatment, but not when you've had one a week before. I probably could have pressed for an exception, but I wanted the trial to get going and this was the easier way. To me the study sponsor should be picking up this expense. I nor my health care plan really needed this additonal scan.
Clinical trial participants are required to review and sign an informed consent document before they enter the trail. This form provides the details of the clinical protocol and your risks. All experimental studies have risks and you need to be careful and decide weather the benefits outweigh the risks. Experimental drugs or procedures may have serious adverse events, so remember to read the informed consent document very carefully.
Mike Morgan
www.bioforcesolutions.com
I have been in quite a few clinical trials and I feel so used right now..
Some of the bigger drug companies do this to you..
I spent 2 years in my last tril, only the beginning couple of weeks were actually with drug and I followed thru on EVERY request they had and now I am SOL....I was under the impression that I would recieve drug after I completed my "time in" and surprise, surprise they now tell me that it will cost me $14000. for 2 infusions...I think at this point I would rather have surgery than give these drug companies one red dime, thru my ins co. or myself..I have NEVER felt so used or so much like a guinea pig in all my life..
When you call them on it and tell them that your informed consent says that you will be entitled to "rescue therapy" their term...You get nothing but run around..I give!!
Sierra57
Interesting article.
Can someone please tell me just how contageous is hepatitis, and should the person be allowed to hold a baby? Someone, please let me know something.
anonymous 4:02 pm -- Try a search on hepatitis and from there you can find out how it is transmitted. I don't think they answer questions on the blog.
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