Trial Phase
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A phase 2 trial is riskier then a phase 3 trial and so on..
Why ?
There are a few reasons and one is that the dosage profile is still being adjusted early on in the trial and adverse effects are still being identified.
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In order to find treatments for chronic hepatitis C that are safe and effective, new drugs, including interferons, must undergo rigorous testing. Drug research involves many stages. Much of the knowledge about drugs is derived from initial laboratory research in animals. Animals are used during the drug development phase, primarily to confirm lack of toxicity. If laboratory tests show that a drug has potential therapeutic value without major toxicity, it may advance to the next stage.
The next step involves an extensive process of applying to the FDA for permission to proceed. After careful review of the preliminary data, if the FDA gives its approval, then drug testing – clinical trials – can begin on humans.
Clinical trials may have up to four phases. The initial introduction of an investigational new drug using humans occurs in
Phase I.
The subjects in this phase are usually healthy volunteers (usually 20 to 80 subjects). Sometimes the subjects are those with the disease that is being studied.The goals of a Phase I trial are to evaluate safety and tolerability (i.e., lack of major side effects) as well as the dosage range. This is determined by testing a range of doses (called a dose-ranging trial). Study participants initially receive a low dose of the drug; this is gradually increased as long as the drug appears to be safe.
Phase I studies may provide early indications of the drug’s effectiveness, but whether or not a drug works is the primary focus of Phase II and Phase III studies.
In Phase II trials, clinical studies are conducted using patients with the disease for which the drug is being tested. The goal of this phase is to obtain preliminary data on the effectiveness (also known as efficacy) of the test drug. This phase also allows further collection of data on the common short-term side effects and risks associated with the drug. A relatively small number of participants enroll in Phase II studies (100 to 300 subjects).
After confirming preliminary evidence of effectiveness in Phase II studies, the goal of Phase III studies is to gain additional information on effectiveness and safety. In this phase, several hundred to several thousand subjects receive the test drug.
In Phase III studies, the new drug is often compared to current standard therapy. After the drug is approved and marketed, the FDA may require acompany to obtain more information about the drug. These studies occur as Phase IV trials.
Examples are the safety and efficacy of varying doses,how the drug interacts with other drugs, or how it works in people with other diseases.
Phase IV trials may include small or large numbers o fsubjects and may reveal uncommon side effects that are too rare to show up in Phase II or III studies.
Any Benefit In Treating In A Trial ?
An obvious benefit of being in a clinical trial is the cost, its free. But, if you have insurance you may be billed for both blood work, and office visits.
Important Questions To Ask
The Policy On Dose Reductions
Ask the trial coordinator about the policy for dose reductions in order to manage any adverse effects. Will they let you adjust the dose if side effects become either a medical problem or intolerable.
Do they allow Rescue Drugs ?
These drugs may be needed to complete treatment ; neupogen to bring up the low white counts and epogen for red blood counts.
Ask if they will cover the cost of any rescue drugs.
What If You Relapse ?
Will you be offered a rollover trial ? A trial with another protocol ?
What is all this Placebo Arm Stuff ?
1-If you are in the "Placebo Group, or Arm" and receiving the placebo will they allow you to treat with the trial medications later ?
2-It is possible you may not receive the best dose, depending on what treatment Arm you have been placed in, remembering that often the optimum dose is often discovered after the trial is over.
Consent forms
.l They should and must have a consent form, you should receive a copy you can review before you sign it. Most likely you will sign it in the doctors office, when you do, think of me, and tell yourself you should be taking this home to read. You are not doing your homework, never sign anything before you read it.
Testing For Viral Load
Ask what PCR test will be used and at what sensitivity. They often use an in house test to save money. The viral load test should measure at least down to 50 viral copies per ml. of blood . There are ultra sensitive tests for research that can detect less than 5 copies. Find out if you are privy to the PCR results.
Criteria For Stopping Treatment
You should know the viral response or protocol of when treatment will be discontinued.
Examples : Complete early viral response (cEVR): a viral load ofless than 50 IU/mL 12 weeks into treatment.
Do they want you to be virus free by the forth week, eighth, or at week twelve ?
An important factor in treating this disease is the success rate achieved
as " Treatment-Naïve ". If you enter into the wrong trial, and respond slowly, or have a break through and maybe even relapse could you be lowering your next chance at clearing this virus ? Would you have achieved SVR if the protocol were different ?
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With Telaprevir and Boceprevir being so close to FDA approval waiting might be the best scenario. I understand not everyone has the resources to wait, and a trial may be the only chance you have to treat this disease.
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If you do enter into a trial read the trial agreement and look closely at the protocol with each arm. Compare SOC or standard of care therapy with the dose of interferon and ribavirin in the said trial.
How much do they differ ?
How much of a risk are you taking ?
Before signing on the dotted line ask yourself if you did all your homework.
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