Stories tagged clinical trials

Jan
06
2010

I just came across the following article in The Scientist. It made me say, are you serious!?!?!

The Scientist: NewsBlog:
Test a vax, fly to Mexico
Posted by Jef Akst
[Entry posted at 6th January 2010 03:00 PM GMT]

Want to go to Central America for free? All it takes is your participation in a clinical trial for a diarrhea vaccine. A patch worn on the arm can earn you a complimentary trip to one of nine cities in Mexico and Guatemala, courtesy of Intercell AG.

The Austrian drug company is recruiting 1800 volunteers for the phase III clinical trial of a vaccine against enterotoxigenic Escherichia coli -- a major cause of traveler's diarrhea, which affects about 20 million visitors to countries such as Africa, Asia and Latin America, as well as illness in more than 200 million children living in those countries each year. If approved, it would be the first vaccine for traveler's diarrhea available in the US.

A couple years ago, we looked at the question of how researchers and companies decide on compensation for subjects' participation in clinical trials. But the trip offered by the Austrian company seems to be an entirely new recruitment tactic, the BMJ reports.

Intercell joined forces with Inclinix, Inc., a North Carolina-based clinical trial enrollment solutions provider, to devise a strategy including partnerships with major travel and tourism websites, as well as a variety of social networking outlets, including Twitter and YouTube. "Social communication avenues allow Inclinix to reach a unique audience," Diane Montross, director of patient recruitment for Inclinix, told Medical News Today. "We are defining the next patient recruitment landscape."

In addition to the flight to Central America, participants will receive at least six nights of three star accommodations, pre-paid mobile phones, welcome kits with useful travel tools, and $1,500 in cash upon completion of the study. Participants will be given either the active vaccine or a placebo before travel, give blood within 48 hours of arrival, keep a stool diary throughout their trip, and provide additional blood and stool samples if they develop diarrhea.

For more information go to the TREK Research Study site.

Sep
13
2009

H1N1 vaccination
H1N1 vaccinationCourtesy AJC1

Making sure vacinations are safe

Before giving H1N1 flu vaccinations to millions of people, clinical trials are needed. What is an effective dose for people of various ages and body types. What are the side effects.

No second shot required for H1N1 flu

Clinical trials are showing that the new H1N1 swine flu vaccine protects with only one dose instead of two. This is very good news. The vaccinations can be given to twice as many people at half the cost.

"Healthy adults got one 15-microgram shot, and their blood was tested 21 days later. By that time, 97 percent of the 120 adults had enough antibodies to be considered protected."
“This is definitely a big deal,” said Dr. John J. Treanor, a vaccine expert at the University oRochester. “People had been planning for a scenario that would require two doses.” New York Times

Pregnant women first

The vaccinations are proving to be effective only 8-10 days after being administered. This may allow all 159 million people in the high risk group (pregnant women, people under 24 years old or caring for infants, people with high-risk medical conditions and health-care workers) to be protected before the swine flu reaches its expected mid-winter peak.

Learn more about H1N1 influenza vaccine clinical trials

The National Institute of Allergy and Infectious Diseases (NIAID) News statement: "Early Results from Clinical Trials of 2009 H1N1Influenza Vaccines in Healthy Adults".

Feb
27
2007

With all the buzz in the news about new vaccines and other drugs and whether or not they're properly tested for safety and efficacy, I was totally intrigued with an article in the December 18, 2006, issue of The New Yorker: "The Right to a Trial: Should dying patients have access to experimental drugs?" (Jerome Groopman)

The whole topic was fascinating, but the article included a summary of the F.D.A. approval process:

"Guaranteeing drug safety has been part of the [Food and Drug Administration's] mandate since 1938, when Congress passed the Federal Food, Drug, and Cosmetic Act after more than a hundred people died from taking a medicine for strep throat which contained diethylene glycol, an active ingredient in antifreeze. Today, the vast majority of patients with life-threatening diseases are treated with drugs that have been approved by the F.D.A. after a stringent evaluation process designed to insure they are safe and effective. It typically takes a pharmaceutical company six and a half years from the time it discovers a promising molecule to gather enough data to apply to the F.D.A. for permission to test a drug on patients. Completing the clinical trials requires, on average, another seven years: an initial set (Phase I), usually involving fewer than a hundred patients, to determine the maximum tolerated dose and likely side effects; a second set (Phase II), involving several hundred patients, to identify the diseases—or stages of a disease—that are affected by the experimental therapy; and a final set (Phase III), in which the drug is given to several thousand patients and compared with another drug that has already been approved by the F.D.A., or with a placebo. After the trials, the F.D.A. reviews the results and, usually in consultation with an advisory panel of experts, decides whether to approve an experimental drug. Drug companies pay most of the costs of clinical trials, and by the time a drug reaches the market the manufacturer will have spent nearly a billion dollars on its development.

Nearly ninety per cent of drugs that enter Phase I trials are eventually abandoned because they are shown to be unsafe or ineffective. (Last week, Pfizer announced that it was canceling its Phase III trial of torcetrapib, an experimental drug for heart disease, after eighty-two patients in the study died. Pfizer had spent almost a billion dollars on torcetrapib, whihc had shown exceptional promise in earlier trials. 'This drug, if it worked, would probably have been the largest-selling pharmaceutical in history,' Steven E. Nissen, the chairman of cardiovascular medicine at the Cleveland Clinic, told the Times.) In the past decade, the number of new drugs approved by the F.D.A. has fallen sharply. According to a recent article in the Journal of the American Medical Association, between 1994 and 1997 the agency approved an average of nearly thirty-six new drugs a year, but between 2001 and 2004 the approval rate averaged just twenty-three a year."

It's kind of mind-blowing. And it explains why drug companies do so much lobbying and marketing directly to patients.

I also found a cool article in the Federal Reserve Bank of Boston's Regional Review, Quarter I, 2003: "Too Much of a Good Thing Can Be Bad." (Carrie Conaway). It's about the development of cholesterol-lowering drugs, which are among the top-sellers in the US, but it touches on the same issues:

"The cost and uncertainty of the drug development process mean that pharmaceutical firms need to receive large returns on any successful drug in order to counterbalance the failures along the way. Yet the products they make, once discovered, are extremely easy for other firms to copy. Without some kind of legal right to the economic returns from their research findings, pharmaceutical companies would have no incentive to develop new drugs—and society would miss out on the new and improved treatments for disease and illness that the companies would discover. To solve this problem, the government grants drug manufacturers patents—short-term monopolies that limit competition and thus help ensure that companies receive a return on their research. But this benefit to inventors comes at a social cost. The shield from competition that patents provide gives manufacturers the economic power to set prices higher than competitive markets would allow, on the very goods that society regards as critically important to make available.

There is no doubt that patents foster innovation, especially for pharmaceuticals. But it is harder to know whether their current structure has struck the right balance between their costs and benefits for society."

What do you think IS the right balance between pharmaceutical costs and their benefits to society? Does FDA licensing make you feel okay about the safety and efficacy of a drug? Do you think that drug prices are fair? What could we do differently?