Dear Readers:
As promised, I have found some research which I think may be helpful to you, or to your loved ones. I will post this first, and then I also have some information on statin drugs in trials, (something about which I had seen living proof in an Italian Oncologist's videos of treatment and cure of cancer with the statins. It was amazing, and so I'm going to share with you shortly information on some studies which were done. There may be one still recruiting. I will do my best to see if this is so, because this is a treatment in which I have much faith.
All that said, here is some information which I hope will
Overview of Clinical Trials
Clinical trials are conducted to collect data regarding the safety and efficacy of new drug and device development. There are several steps and stages of approval in the clinical trials process before a drug or device can be sold in the consumer market, if ever.
Drug and device testing begins with extensive laboratory research which can involve years of experiments in animals and human cells. If the initial laboratory research is successful, researches send the data to the Food and Drug Administration (FDA) for approval to continue research and testing in humans.
Once approved, human testing of experimental drugs and devices can begin and is typically conducted in four phases. Each phase is considered a separate trial and, after completion of a phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase.
Human Clinical Trial Phases
Phase I studies assess the safety of a drug or device. This initial phase of testing, which can take several months to complete, usually includes a small number of healthy volunteers (20 to 100), who are generally paid for participating in the study. The study is designed to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. This phase also investigates the side effects that occur as dosage levels are increased. About 70% of experimental drugs pass this phase of testing.
Phase II studies test the efficacy of a drug or device. This second phase of testing can last from several months to two years, and involves up to several hundred patients. Most phase II studies are randomized trials where one group of patients receives the experimental drug, while a second "control" group receives a standard treatment or placebo. Often these studies are "blinded" which means that neither the patients nor the researchers know who has received the experimental drug. This allows investigators to provide the pharmaceutical company and the FDA with comparative information about the relative safety and effectiveness of the new drug. About one-third of experimental drugs successfully complete both Phase I and Phase II studies.
Phase III studies involve randomized and blind testing in several hundred to several thousand patients. This large-scale testing, which can last several years, provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug or device, the benefits and the range of possible adverse reactions. 70% to 90% of drugs that enter Phase III studies successfully complete this phase of testing. Once Phase III is complete, a pharmaceutical company can request FDA approval for marketing the drug.
Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage: (1) to compare a drug with other drugs already in the market; (2) to monitor a drug's long-term effectiveness and impact on a patient's quality of life; and (3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Phase IV studies can result in a drug or device being taken off the market or restrictions of use could be placed on the product depending on the findings in the study.
Participating in a Clinical Trial
For more detailed information and answers to frequently asked questions about participating in clinical trials, please visit Volunteering for a Clinical Trial.
Funding Clinical Trials
Funding for clinical research comes from the federal government such as the National Institutes of Health, the Department of Defense, the Department of Veteran's Affairs, and private industry such as pharmaceutical and biotech companies, medical institutions, and foundations.
If you or someone you love has recently been diagnosed with malignant mesothelioma, then find out the necessary facts about your legal rights by requesting FREE information.
As promised, I have found some research which I think may be helpful to you, or to your loved ones. I will post this first, and then I also have some information on statin drugs in trials, (something about which I had seen living proof in an Italian Oncologist's videos of treatment and cure of cancer with the statins. It was amazing, and so I'm going to share with you shortly information on some studies which were done. There may be one still recruiting. I will do my best to see if this is so, because this is a treatment in which I have much faith.
All that said, here is some information which I hope will
Overview of Clinical Trials
Clinical trials are conducted to collect data regarding the safety and efficacy of new drug and device development. There are several steps and stages of approval in the clinical trials process before a drug or device can be sold in the consumer market, if ever.
Drug and device testing begins with extensive laboratory research which can involve years of experiments in animals and human cells. If the initial laboratory research is successful, researches send the data to the Food and Drug Administration (FDA) for approval to continue research and testing in humans.
Once approved, human testing of experimental drugs and devices can begin and is typically conducted in four phases. Each phase is considered a separate trial and, after completion of a phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase.
Human Clinical Trial Phases
Phase I studies assess the safety of a drug or device. This initial phase of testing, which can take several months to complete, usually includes a small number of healthy volunteers (20 to 100), who are generally paid for participating in the study. The study is designed to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. This phase also investigates the side effects that occur as dosage levels are increased. About 70% of experimental drugs pass this phase of testing.
Phase II studies test the efficacy of a drug or device. This second phase of testing can last from several months to two years, and involves up to several hundred patients. Most phase II studies are randomized trials where one group of patients receives the experimental drug, while a second "control" group receives a standard treatment or placebo. Often these studies are "blinded" which means that neither the patients nor the researchers know who has received the experimental drug. This allows investigators to provide the pharmaceutical company and the FDA with comparative information about the relative safety and effectiveness of the new drug. About one-third of experimental drugs successfully complete both Phase I and Phase II studies.
Phase III studies involve randomized and blind testing in several hundred to several thousand patients. This large-scale testing, which can last several years, provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug or device, the benefits and the range of possible adverse reactions. 70% to 90% of drugs that enter Phase III studies successfully complete this phase of testing. Once Phase III is complete, a pharmaceutical company can request FDA approval for marketing the drug.
Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage: (1) to compare a drug with other drugs already in the market; (2) to monitor a drug's long-term effectiveness and impact on a patient's quality of life; and (3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Phase IV studies can result in a drug or device being taken off the market or restrictions of use could be placed on the product depending on the findings in the study.
Participating in a Clinical Trial
For more detailed information and answers to frequently asked questions about participating in clinical trials, please visit Volunteering for a Clinical Trial.
Funding Clinical Trials
Funding for clinical research comes from the federal government such as the National Institutes of Health, the Department of Defense, the Department of Veteran's Affairs, and private industry such as pharmaceutical and biotech companies, medical institutions, and foundations.
If you or someone you love has recently been diagnosed with malignant mesothelioma, then find out the necessary facts about your legal rights by requesting FREE information.
Thanks for valuable information keep it up
ReplyDeleteThat is a very informative post, many people out there do not have the correct information with regards to their rights. There should be a drive aimed at sensitizing people on all their rights in accordance to the laws of this country with respect to health and treatment of diseases.
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