Thanks for the reply. I'm waiting for the clinical trials dept. to make contact with me. Alice: you do have to travel far for treatment so I better quit complaining.
As you consider CT's & fortunately there are many choices now ... however they are not created equally ...
Here are a few questions you may want to know the answers to .. it's a basic list and may be a bit dated ..
Here is a initial list of questions for anyone who is considering participating in medical research ie: Clinical Trials .. the answers you might want to know before signing up ... kindly add to it if you have any others that I've missed ... and remember , Clinical Trials are for data gathering , not about the patient ..
Things to ask before participating in a trial :
It would be good to know the Phase of the trial. The goal of a trial is not necessarily to "cure" people.
In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
Are Rescue drugs ie: drugs such as epo, GCSF (Neupogen) etc allowed or not allowed and If no rescue drugs are given ...what action is taken in regards to decreasing Hgb.,whites,platlets etc., and at what levels do they intercede?
Would you have the ability to self pay for rescue drugs if they are needed and not provided by the trial protocol?
What access do I have to lab results during the course of my trial participation?
Will I receive hard copies of lab results, and how are they transmitted to me?
What are the parameters for intervention in the event I develop cytopenia such as hemolytic anemia, neutropenia, etc.
I understand genetic sequencing is generally conducted as part of HCV drug trials to study viral mutation. Will this data be made available to me, and if so, at what time?
What are the statistical odds I will receive placebo in this trial?
For those patients that don’t respond fully to the trial (SVR) will the study drug be made available to them at a later date (roll over program)?
Will participation in this trial limit my future participation in trials and how so?
Who will directly manage my care throughout my trial participation; Physician, NP, PA, RN
How often will i need to come into the clinic? How long will the appointments take? Can i schedule the appointments to suit my schedule?
Can I get a commitment to receive any sequencing (population and clonal if available) results done on my virus in the case of failure? (Push strongly for this given the importance of understanding resistance as best one can.)
When will the study be unblinded (if it is)?
What are the response parameters for determining whether treatment will continue, how long it will continue for, or if it will stop?
Follow this link to a good review of what trials are about ....
http://www.hcvadvocate.org/community/Clinical_Trials.htmCheers , Adn
