Hepatitis C Support Group
Hepatitis C is a blood-borne viral disease which can cause liver inflammation, fibrosis, cirrhosis and liver cancer. The hepatitis C virus (HCV) is spread by blood-to-blood contact with an infected person's blood. Many people with HCV infection have no symptoms and are unaware of the need to seek treatment. Hepatitis C infects an estimated 150-200 million people worldwide.
Obviously, before you enroll in a specific study, you should take time to reviewthe patient informed consent document that you will have to sign.
Be sure to ask how often you will see a doctor; doctor appointment vary at the different study sites.
You should also consider all the pros and cons of any study.
On the poitive side:
1. You may get to try a new treatment that i not available through general clinical practice.
2. Typically, you would receive frequent examinations and careful follow-up.
3. Study coordinators will keep you informed about your status and progress.
4. Most Studies are sponsored by either pharmaceutical companies or research grants, and typically your treatment is delivered without expense to you or your insurer.
However, the degree of compensation can vary and you (or your insurer) may be responsible for some of the bill. Some studies also give extra compensation to you for expenses related to travel to the Study site or for the time you spent participating in the research.
5. Your participation is kept confidential.
Representatives from the FDA or Study sponsors, however, have the right to review your study record.
6. You reserve the right to stop treatment and withdraw from the study at any time.
On the negative side:
1. Testing programs are rigid. You must make the time commitment to follow the protocol exactly.
For example: you'll have to show up at certain times for follow-up-tests.
2. Clinical trials are usually blinded. That means that you won't know what you're getting in terms of dosage or placebo, for example.
If you have been given a placebo, the pharmaceutical company may offer the active drug to you (free of charge) at the end of your participating in the trial if you completed the study.
3.Sponsors can stop the trials at any time.
4. You may experience undocumented side effects.
5. You must be prepared to reveal all apects of your physical and emotional health.
6. You won't know the results of the whole study, or your individual results, until every participant has completed the protocol. It may take more than a year from your point of enrollment.
If you fail to meet criteria for entry into the controlled studies, it is still possible to treated with investigational drug through compassionate-use protocols.
Typically, drugs available on a compassionate-use basis have not yet received FDA approval.
Physicians gain access to these drugs by contacting the pharmaceutical sponsor.
Living with hep c
Gregory T Everson
MD
Be sure to ask how often you will see a doctor; doctor appointment vary at the different study sites.
You should also consider all the pros and cons of any study.
On the poitive side:
1. You may get to try a new treatment that i not available through general clinical practice.
2. Typically, you would receive frequent examinations and careful follow-up.
3. Study coordinators will keep you informed about your status and progress.
4. Most Studies are sponsored by either pharmaceutical companies or research grants, and typically your treatment is delivered without expense to you or your insurer.
However, the degree of compensation can vary and you (or your insurer) may be responsible for some of the bill. Some studies also give extra compensation to you for expenses related to travel to the Study site or for the time you spent participating in the research.
5. Your participation is kept confidential.
Representatives from the FDA or Study sponsors, however, have the right to review your study record.
6. You reserve the right to stop treatment and withdraw from the study at any time.
On the negative side:
1. Testing programs are rigid. You must make the time commitment to follow the protocol exactly.
For example: you'll have to show up at certain times for follow-up-tests.
2. Clinical trials are usually blinded. That means that you won't know what you're getting in terms of dosage or placebo, for example.
If you have been given a placebo, the pharmaceutical company may offer the active drug to you (free of charge) at the end of your participating in the trial if you completed the study.
3.Sponsors can stop the trials at any time.
4. You may experience undocumented side effects.
5. You must be prepared to reveal all apects of your physical and emotional health.
6. You won't know the results of the whole study, or your individual results, until every participant has completed the protocol. It may take more than a year from your point of enrollment.
If you fail to meet criteria for entry into the controlled studies, it is still possible to treated with investigational drug through compassionate-use protocols.
Typically, drugs available on a compassionate-use basis have not yet received FDA approval.
Physicians gain access to these drugs by contacting the pharmaceutical sponsor.
Living with hep c
Gregory T Everson
MD
-
My 6mo twin DD's are EBF and just started rice cereal on the first. Everything has been going fine except this morning one of them had a diaper rash (lots of redness around her anus). I read this as one of the signs of an allergy. BUT I did just buy a different brand diaper yesterday (which they have used randomly before w/no issues). Do you think its the cereal or the diaper? Im ready to start...
Thanks for posting it!