Tidbits on Clinical Trials (Government monitored to hopefully become FDA approved)~Provenge sampled

Someone else whom is really familar or well read on this type of thing,could say alot more and better, but the basics on it are this: (web found)-

What is a Clinical Trial?

Clinical trials are the bridge over which all new medical therapies must pass to become accepted practice—and the bridge is a long one. For patients, clinical trials can typically last for a few weeks or months. For scientists, they can continue on for years before a new therapy may see the light of day.

There are different types of clinical trials: treatment, prevention, diagnostic, screening, and quality of life trials—and the trials are conducted in progressive phases (I-IV). Once a clinical trial reaches the end of the bridge–proving its potential worth as a medical therapy–the Food and Drug Administration (FDA), a government agency, must officially approve the therapy for medical consumers.

For patients, participation in a clinical trial is voluntary. Common reasons for joining a clinical trial include: playing a more active role in your own health care; gaining access to innovative treatments before they become widely available; and helping others by contributing to advancements in medical research.

How Do Clinical Trials Work?

To ensure that no one can influence the results of a study, clinical trials employ a range of specialized testing mechanisms intended to prevent bias and provide reliable results:

Prospective Trials—Patients are identified and then followed over time.
Randomized Trials—Patients are grouped by chance into (typically) a treatment group and a control group (also called a placebo group). A control group receives either the current standard treatment or a placebo-an inactive pill or liquid. The results of the control group are then compared with those of the treatment group.
Cross-over Trials—Patients receive both the treatment and the placebo at different times, with careful monitoring of their responses to both approaches.
Double-blinded Trials—Neither the patient nor the researcher knows if the patient is receiving the treatment or the placebo.
In addition, some clinical trials are called open label studies, because both the patient and the researcher know that the patient is receiving the treatment and not the placebo.

By federal regulation, every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB), an independent committee of physicians, statisticians, community advocates, and others. The IRB is charged with ensuring that all clinical trials within a given medical institution are ethical and that the rights of the participants in those trials are protected.

Clinical trials retain very specific participation guidelines. Establishing and maintaining these guidelines is a critical part of producing meaningful and reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria," while those that disallow someone are called "exclusion criteria." Typical criteria include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

What are the Different Types of Clinical Trials?

Treatment Trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
Prevention Trials look for better ways to prevent a given disease in people who have never had that disease or to prevent a disease from returning. Preventative approaches include medicines, vitamins, vaccines, minerals, and lifestyle changes.
Diagnostic Trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
Screening Trials test the best way to detect certain diseases or health conditions.
Quality of Life Trials (or supportive care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
What are the Phases of Clinical Trials?

Clinical trials are conducted in phases. Each phase of a trial has a different purpose and helps scientists to answer specific questions.

While small, early phase trials may be conducted by individuals or small groups of physicians, larger trials are typically conducted by hospitals, pharmaceutical companies, or device manufacturers. If a therapy successfully passes through phase III trials, the FDA may approve it to be marketed to the public.

Phase Definition
Phase I Trials Researchers test a new 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.
Phase II Trials The 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.
(PHASE III TRAILS):The 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 drug or treatment to be used safely.

My wording now as mentioned to me by my onco-doc whom is a wonderful fair minded guy, says alot of drugs that even had shown some promise and results, get the axe because of lack of funding and money, sometimes in Phase II, III good stuff just doesn't make it to patients and could have been a useful thing. So, money sometimes is an obstacle or drug mfg's. may decide it isn't worth it to proceed...and my thoughts heaven forbid they might have other reasons to kill a drug from coming onto the market, we have to wonder about such .

Thanks buddy and hope your catheter days are over with now, maybe save that last one and frame it as a momento and wall discussion item (lol).
No fun to wear those even for a few days, let alone long periods of time. Hope your in good shape going forward, you had one of the worst tribulations I can remember hearing about over the years.

When I told the family I had PCa, my sister told me to look into the clinical trials that her company was working on. I think the company was MedImmune, and the trials were for an immunological treatment. But, as sometimes happens, that particular approach didn't work out that well, and the trial had already ended. I didn't pursue any other clinical trials, but I appreciate those men who take part in them, making medical progress possible.

DJ

Thanks for the info Zufus.

I'd like to add that the label form of Provenge that will likely be approved this year by the FDA is for treatment of hormonal resistant PCa. It was found after the 2007 FDA rejection, that booster shots improved the results. The testing/trial noted above, is for early PCa; it is hopeful that Provenge will eventually be useful for all phases of PCa. As to the label form that will hopefully be approved later this year, it should prove to be better than Taxotere, in both life extension and quality of life. It may also be tried, in tandem, with Taxotere, although that would be regarded as experimental and, as such, insurance would likely cover neither, both of which are/will be VERY expensive.

Do some Google research and find out how politics was involved in the FDA denying Provenge approval in 2007.