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| GoodBye |
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Posted: 1/31/2008 11:44 PM |
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Subject: Clinical research! |
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WomanSaver MoFo
Female Member
Age: 29
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Total Posts: 921
L.A
California
United States
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Hi doc,
I was wondering if you could tell me what you think about people involving themself in clinical research studies for money, I don‘t mean your personal views but your concern as a medical professional and what advice do you have to give to individuals that wish to do this?. In case some of you don‘t know hat I am talking about let me explain. there are pharmaceutical companies that use people to test medications before they are released on the market. this consists of taking the medication and reporting any side effects etc that you may encounter as well as a specified amount of blood draws and dietary restrictions. I personally have done this quite a few times and it has helped me tremendously financialy, I have been able to save alot of money and pay for school, alot of other people I know have also done it to catch up on bills. I think that there are alot worse things people could be doing for money. Sometimes it is sort of draining, once I was in a study where they needed 24 blood draws in one day to see the absorbtion of a medication. I always follow the the restrictions such as no smoking, taking other meds and stuff like that and I do not abuse this or use it as my main source of income I do it maybe 3-4 times a year if not less. Plus the medicals are quite thorough I am just wondering if I will have any longterm complications from continuing to do this once in a while and will my veins get damaged from doing so many blood draws?
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| hopeless_dreamer |
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Posted: 2/1/2008 12:35 AM |
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Subject: Clinical research! |
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WomanSaver MoFo
Male Member
Age: 23
Total Posts: 697
Los Angeles
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You need to be very clear about what you are discussing here. If you are talking about a research study, then there is likely no long-term risk involved because they are generally studying the effects of known FDA approved drugs under certain conditions/environments/dosages/etc.
However, if you are participating in clinical drug trials your veins should be the least of your concern. There‘s a reason they pay you to participate in a phase 3 clinical trial: the drugs are experimental. There‘s no knowledge of what effect they will have on the body. You are performing the service of testing what effect these drugs will have. No one can tell you what the long-term consequences of the drugs you have taken will be because nobody knows. Most of the drugs that go through phase 3 clinical trials don‘t get to the market because of the long-term side-effects. You‘re basically accepting money so you can be a number to show what the consequences of taking the drug will be.
Now, I‘m not sure which one you were referring to, but if you were posting about the first scenario, there should be no real issue. However, if you were referring to the second scenario, you may reconsider being such an active participant.
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| GoodBye |
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Posted: 2/1/2008 5:46 PM |
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Subject: Clinical research! |
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WomanSaver MoFo
Female Member
Age: 29
Total Posts: 921
L.A
California
United States
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| hopeless_dreamer wrote: |
You need to be very clear about what you are discussing here. If you are talking about a research study, then there is likely no long-term risk involved because they are generally studying the effects of known FDA approved drugs under certain conditions/environments/dosages/etc.
However, if you are participating in clinical drug trials your veins should be the least of your concern. There‘s a reason they pay you to participate in a phase 3 clinical trial: the drugs are experimental. There‘s no knowledge of what effect they will have on the body. You are performing the service of testing what effect these drugs will have. No one can tell you what the long-term consequences of the drugs you have taken will be because nobody knows. Most of the drugs that go through phase 3 clinical trials don‘t get to the market because of the long-term side-effects. You‘re basically accepting money so you can be a number to show what the consequences of taking the drug will be.
Now, I‘m not sure which one you were referring to, but if you were posting about the first scenario, there should be no real issue. However, if you were referring to the second scenario, you may reconsider being such an active participant.
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 The studies I participate in the drug is already approved in Europe and the U.S. and from what I know every country has it‘s own FDA approval even if it is the same drug since standards vary from different countries. I always make sure the drug is approved else where before participating I never participate when it is a new unknown drug because that is just too risk for me....Life is preciours and I have a child to live for.
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| Dr.WomanSaverM.D. |
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Posted: 2/5/2008 7:08 PM |
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Subject: Clinical research! |
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WomanSaver MoFo
Female Member
Age: 100
Total Posts: 553
Doctor's Office
Costa Rica
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| GoodBye wrote: | | Hi doc, I was wondering if you could tell me what you think about people involving themself in clinical research studies for money, I don‘t mean your personal views but your concern as a medical professional and what advice do you have to give to individuals that wish to do this?. In case some of you don‘t know hat I am talking about let me explain. there are pharmaceutical companies that use people to test medications before they are released on the market. this consists of taking the medication and reporting any side effects etc that you may encounter as well as a specified amount of blood draws and dietary restrictions. I personally have done this quite a few times and it has helped me tremendously financialy, I have been able to save alot of money and pay for school, alot of other people I know have also done it to catch up on bills. I think that there are alot worse things people could be doing for money. Sometimes it is sort of draining, once I was in a study where they needed 24 blood draws in one day to see the absorbtion of a medication. I always follow the the restrictions such as no smoking, taking other meds and stuff like that and I do not abuse this or use it as my main source of income I do it maybe 3-4 times a year if not less. Plus the medicals are quite thorough I am just wondering if I will have any longterm complications from continuing to do this once in a while and will my veins get damaged from doing so many blood draws? |
Hi GoodBye, There are definitely various risks associated with participating in a clinical trial. The adverse effects depend on what type of medication they are testing and can vary from mild to severe, immediate to long term. Like HD said, noone really knows what the side effects will be since this is why they are testing this medication on the research population in the first place -to see if it is effective and also to determine what the possible side effects can be. If the drug is already approved in another country, you can read the drug information, and find out the possible side effects to find out more.
Another thing to keep in mind is that a medication can affect people in various ways. For example person A may have no side effects whatsoever, person B may have mild side effects while person C may develop some life threatening adverse reaction, all to the same medication.
And finally, if you are participating in a case-control study, you may not be getting the medication at all; instead you will be taking a placebo, but there is no way of knowing which you are getting.
Here is some information from http://clinicaltrials.gov/ct2/info/understand
You can read more about clinical trials at: http://clinicaltrials.gov/
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
- Play an active role in their own health care.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading health care facilities during the trial.
- Help others by contributing to medical research.
There are risks to clinical trials.
- There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
- The experimental treatment may not be effective for the participant.
- The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants‘ names will remain secret and will not be mentioned in these reports (See Confidentiality Regarding Trial Participants).
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow up care is part of this study?
- How will I know that the experimental treatment is working? Will results of the trials be provided to me?
- Who will be in charge of my care?
- Plan ahead and write down possible questions to ask.
- Ask a friend or relative to come along for support and to hear the responses to the questions.
- Bring a tape recorder to record the discussion to replay later.
Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
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