What Is a Clinical Trial?

May 13, 2009

What Is a Clinical Trial?

Clinical trials are research studies in which people help doctors find ways to improve health and cancer care. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer.

Why are there clinical trials?

A clinical trial is one of the final stages of a long and careful cancer research process. Studies are done with cancer patients to find out whether promising approaches to cancer prevention, diagnosis, and treatment are safe and effective.

What are the different types of clinical trials?

Treatment trials test new treatments (like a new cancer drug, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy).

Prevention trials test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of a certain type of cancer.

Screening trials test the best way to find cancer, especially in its early stages.

What are the phases of clinical trials?

Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Most clinical trials are classified into one of three phases:

* Phase I trials:

These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.

* Phase II trials:

A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.

* Phase III trials:

These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors’ offices, clinics, and cancer centers nationwide.

Source: National Cancer Institute

FDA 101: Health Fraud

May 13, 2009

What is Health Fraud?

Health fraud is the deceptive sale or advertising of products that claim to be effective against medical conditions or otherwise beneficial to health, but which have not been proven safe and effective for those purposes.

Common Types of Health Fraud

Cancer fraud:

Among the many long-running cancer scams is the Hoxsey Cancer Treatment, an herbal regimen that has no proven benefit. Another scam involves products called black salves. These are offered with the false promise of drawing cancer out from the skin, but they are potentially corrosive to tissues.

HIV/AIDS fraud:

There are legitimate treatments that can help people with the human immunodeficiency virus (HIV). While early treatment of HIV can delay progression to AIDS, there is currently no cure for the disease.

Arthritis fraud:

The U.S. Federal Trade Commission says consumers spend about $2 billion annually on unproven arthritis remedies that are not backed by adequate science.

Fraudulent “diagnostic” tests:

Doctors often use in vitro diagnostic (IVD) tests—in tandem with a physical examination
and a medical history—to get a picture of a patient’s overall health.

Bogus dietary supplements:

The array of dietary supplements—including vitamins and minerals, amino acids, enzymes, herbs, animal extracts and others—has grown tremendously.

Weight loss fraud:

Since 2003, FDA has worked with national and international partners to take hundreds of compliance actions against companies pushing bogus and misleading weight loss schemes.

Sexual enhancement product fraud:

FDA has warned consumers about numerous illegal drugs promoted and sold online for treating erectile dysfunction and for enhancing sexual performance.

Diabetes fraud:

FDA has taken numerous compliance actions against sales of fraudulent diabetes “treatments” promoted with bogus claims such as

* “drop your blood sugar 50 points in 30 days”
* “eliminate insulin resistance”
* “prevent the development of type 2 diabetes”
* “reduce or eliminate the need for diabetes drugs or insulin”

Influenza (flu) scams:

Federal agencies have come across contaminated, counterfeit, and subpotent influenza products.

FDA, with U.S. Customs and Border Protection, has intercepted products claimed to be generic versions of the influenza drug Tamiflu, but which actually contained vitamin C and other substances not shown to be effective in treating or preventing influenza.

Source: FDA

U.S. Job Losses Not Due to H-1B Visas, Report Says

May 13, 2009

New H-1B visa holders don’t make much of a dent in the U.S. workforce, according to a report by the National Foundation for American Policy.

US lawmakers may be busy putting restrictions on the country’s primary temporary work visa, H-1B, but new H-1B visaholders each year represent just seven in 10,000 civilian workers in the US, according to a report by an American public policy organisation.

As per the report by the National Foundation for American Policy (NFAP), 107,686 new H-1B petitions were approved by the US Citizenship and Immigration Services in 2008, including those exempt from being included in the H1-B quota of 85,000 visas annually. In comparison, the American civilian labour force stood at 154.6 million in 2008.

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