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

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Why Your Doctor Wants You to Participate In a Clinical Trial

You're in the doctor's office -- maybe it's the primary care physician you or your family sees all the time, maybe it's a specialist you've been referred to. Maybe you have a new condition you're concerned about, maybe you are just in for a routine physical. But, after examining you, the doctor says she thinks you would be a good candidate for a clinical trial and asks whether or not you would be interested.

You probably trust your doctor. To some degree, you have to -- whether you like her or not. She knows things you don't, so you put considerable trust in what she suggests.

So, before you register at the front desk for the guinea pig suite, you might wonder what's in it for your doctor? Why is she suggesting that you, her patient, be subjected to the risks and benefits of a clinical trial?

First of all, assuming she has your best medical interests in mind, she may have reason to believe that you will benefit medically by participating. If you're ill or have a particular condition the clinical trial is designed to treat, and if past and current therapies are not satisfactory or the side effects are bothering you, she may feel that the therapy being tested would offer you an opportunity to improve your health.

Second, her practice may be paid for every participant enrolled in the clinical trial. Such payment typically amounts to covering the expenses of administering the clinical trial. Bonuses or "finder's fees" are usually considered improper, although they are not unheard of. The principle most often followed is that any such incentive to the doctor or her practice not be so great as to cause her to pressure patients into participating.

Third, your doctor may feel that her practice would benefit generally from offering clinical trial opportunities to its patients. Perhaps the opportunities would attract new patients.

Finally, she may be interested in learning more about medicine and medical research by participating as an investigator in clinical trials. She will become familiar with the latest advances and will observe first-hand how such advances are translated into practice.

In different ways, all of the above reasons for your doctor's interest in clinical trials may well be to your advantage as a patient.

-Joe


Related Topics: Americans Want More Medical Research, Sorting Through the Latest Drug Studies

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