Volunteers for clinical trials are essential -- when they enroll for the right reasons
Filed under: Healthcare
Stories about clinical drug trials pop up regularly in the news. Sometimes, that news is good because a novel drug proves itself to be a promising improvement over existing treatments, or even better when it represents a breakthrough against a previously untreatable disease. Of course, drug trials also make news when their results are disappointing, or worse, when the drug turns out to be harmful or potentially harmful to patients. The latter happened again most recently on Oct. 9, when Pfizer Inc. (PFE) said it halted patient enrollments in a late-stage lung- cancer trial for safety reasons, as the accompanying news story recounts.
But what exactly are clinical trials, and how do they work? Bascially, they're studies in which people volunteer to have new drugs or procedures tested on them. Researchers then closely monitor the trials to learn whether a new treatment works and is safe for people. Sounds scary? It shouldn't be. There are definite risks, but the benefits to society are immeasurable.
Unfortunately, volunteers who participate in these trials may not always have the right reasons for signing up. For instance, with the recession still taking its toll on the labor market, research clinics have reported anecdotal evidence about a "definite uptick in the number of patients," as ABC15.com reports, possibly as healthy people seek ways to earn a few extra bucks.
A quick internet search reveals many services, such as BioTrax and Paid Clinical Trials, that provide information for interested individuals and even more blogs and articles on the matter. Some people actually become professional guinea pigs, claiming that at $3,000-$6,000 ($100 to 300 a day) for each study, they can earn between $20,000 and $35,000 a year. It quickly becomes clear that it's a problem if individuals volunteer for trials not for the advancement of medical research but because of financial motivation or desperation. That's doubly so when volunteers don't appreciate the risks involved.
The Pfizer study, which is using lung-cancer patients, demonstrates the potential risks. The drugmaker puts it well on its site, saying "Pfizer recognizes that compensation to human research subjects should be structured so that subjects are not unduly influenced by such offers of compensation."
The U.S. Food & Drug Administration strictly regulates all clinical studies so that potential subjects are well informed of all events, including possible side effects, that may occur in a particular study, before the trial and during it. This is done through informed consent, which is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It's also a continuing process throughout the study to provide information for participants. Doctors and nurses involved in the trial explain the details of the study to participants, and translation assistance can be provided if English isn't a participant's native language.
Then the research team provides an informed consent document, which describes the study participants' rights and includes details about the study, such as its purpose, duration, required procedures and key contacts. Risks and potential benefits are also explained there. Only when everything is clear should participants make the decision to sign up or not -- regardless of any financial payment. Informed consent is not a contract, and the participant may withdraw from the trial at any time. This is meant to keep health risks to a minimum.
In addition to pharmaceutical companies, clinical trials are also conducted by hospitals, universities and clinics -- often in collaboration. And such human trials are actually only a part of the research that goes into developing a new treatment. When a drug is developed, it first undergoes pre-clinical trials, including cell and animal studies. Then a request to study the drug in humans must be filed with the FDA. Only after approval is granted can the clinical trial phases begin.
These trials have several official Phases. In Phase 0, low drug doses are tested. Phase I tests the drug's safety in a small number of people (15 to 50). Phase II expands the trial to a larger group of 25 to 100 patients to test the treatment's efficiency. And Phase III, which uses a still-larger group, compares the safety and effectiveness of the new treatment against the current standard treatment. Lastly, Phase IV is a follow-up study after the drug has been approved and marketed to see what more can be learned about it.
The importance of clinical trials and participation in them cannot be emphasized enough. For example, while the Pfizer halt is a blow to the largest drugmaker in the world, the blow to patients is bigger because lung cancer is the leading cause of cancer deaths in the U.S. But, as Shari Roan of the Los Angeles Times wrote a few months back, it seems like Americans actually are unwilling to participate in clinical trials, "something which has been a serious drag on medical research."
One problem is that sometimes, as in the Pfizer lung-cancer study, safety issues crop up that should have been addressed in earlier phases. So, it's no wonder volunteers are hesitant. Researchers "acknowledge that some trials have been poorly conducted, risking patient health and dimming the public's view of medical research," Roan writes. In addition, information on how clinical trials are conducted is often poor, and more needs to be done to educate patients and make it easier to enroll safely in trials.
ClinicalTrials.gov, the National Cancer Institute and TrialCheck of the Coalition for Cancer are good places to start searching for clinical trials in general and cancer research studies in particular. The American Cancer Society also explains exactly the process and the importance of clinical trials. As in any risky endeavor, prudence is essential for drug-trial participants. When the decision to go ahead is made with full information and for the right motivation, however, the rewards are extremely compelling.



























Reader Comments (Page 1 of 1)
10-12-2009 @ 5:50PM
Lee said...
I don't think Hillary would have been a bad president but Obama is
president now, and won't be forever. I wish people would just let him
breath a little. He has great intentions. If we had elected McCain he
would be bankrupt by now since he would have spent more trillions on
military spending and I for one, have had enough of wars. We need a
military but for defense purposes and not to fight other people wars.
We need to focus on domestic issues and not international ones.
Like make it illegal for employers to discriminate based on poor
credit. Today a lovely person WASN"T hired because of her credit which
leads me to believe it must be a crime to be poor. Why else would
someone say no based on bad credit. Doesn't everyone had poor credit,
especially if your a company owner because vendors check your credit.
This will hurt the economy because some won't be able to open up
companies and those who can't get work will continue to stay on
unemployment and raise disability claims. Where's the brains here.
I despise HITLER but he was a genius when it came to unemployment. He
made the men go to work and asked women to raise their kids, take care
of their husbands, families and home life. Give the jobs to men and
give women the option to stay home (work also) and women who have no
choice to work, pay them equal pay. Maybe we should try this for a
year or two to get the recession going, or better yet, TAX all
religious facilities since I don't see then take care of those in
need. I see a gold Vatican mansion, that's what I see. Common sense is what
will work, and I'm glad we have a common sense president and no doubt
he will win again.
Reply
10-13-2009 @ 1:23AM
wil said...
Yes. I Agree, sorta. Obama must be a better president than McCain would have been because he has managed to bankrupt the Country by spending trillions without spending on the military .
I'm not Jewish, but if you were Jewish Lee, I don't think you would have the same high praise for Hitler that you expressed. It's just a gut-feeling on my part. Helping citizens of a country to find work by starting a world war that killed millions and destroyed Europe is really not my idea of sensible economic policy. Look beyond the short term cure and see what happened to Germany because of Hitler.
Don't be so eager to have religious Institutions taxed. They have tax-exempt status because of a long tradition of basically not for profit activities that have had social value to millions. There may be pockets of wealth as you would expect in an organization that has lasted for many centuries, but the real value of helping people comes from the Faithful who do not live, for example, in the opulent surroundings of the Vatican. Read about Saint Francis. The people who spend their lives in service helping others, materially and spiritually, do not seek to have their efforts publicized. You don't like Religious organizations. OK. That's your right. Some people may not like Basketball. Should we adapt a special luxury tax for basketball players because they are wealthy and live in mansions?
Who decides who is deprived of wealth, honestly accumulated?
I don't agree with you Lee on a few things that you said, but, at least you have an opinion that you are willing to share. That's a good thing.
10-13-2009 @ 5:58AM
MyKisa said...
....the word is, we are bankrupt...and thats without Mcsame
10-12-2009 @ 7:11PM
L R said...
1
10-12-2009 @ 5:50PM
Lee said…>>>>>>>>>>>>Life Could Be A Dream......... (Sh-boom)- If I could you take you up in paradise above…..
Reply
10-12-2009 @ 8:18PM
Bill said...
I volunteer for the study on beer, steak and lobster.
Reply
10-13-2009 @ 7:57AM
pukin said...
what a sicking way to have to surive in the USA thanks washington including bush of course
Reply
10-13-2009 @ 9:19AM
Julie said...
We were a bankrupt country, in more ways than one, long before Obama took office. He's only been President for 9 months , way too short a period to be judged so harshly by some of you folks. If you survived 96 months of the Bush administration, you'll live through the Obama years, too. Just calm down, be more open-minded, think positive for a change, stop listening to Fox's "hype-masters," read a newspaper, and see what happens. Things are bound to improve, and you'll weather the economic, political, and social storms just fine.
Reply
10-13-2009 @ 10:57AM
Croppy Cait said...
DrugZ??? Sign me up!!! I want the same shet that congress and the Prez are taking!!!
Brahahahahahahahahahahahaha
Reply
10-13-2009 @ 3:31PM
longshot said...
The Obama Theory of the Ant!.. The ant works hard in the withering heat all summer long, building his house and laying up supplies for the winter...The grasshopper thinks the ant is a fool and laughs and dances and plays the summer away.... Come winter, the shivering grasshopper calls a press conference and demands to know why the ant should be allowed to be warm and well fed while others are cold and starving.... CBS, NBC , PBS, CNN, and ABC show up to provide pictures of the shivering grasshopper next to a video of the ant in his comfortable home with a table filled with food.. America is stunned by the sharp contrast.... How can this be, that in a country of such wealth, this poor grasshopper is allowed to suffer so? .... Kermit the Frog appears on Oprah with the grasshopper and everybody cries when they sing, 'It's Not Easy Being Green.... Acorn stages a demonstration in front of the ant's house ....where the news stations film the group singing, 'We shall overcome,Rev.. Jeremiah Wright then has the group kneel down to pray to God for the grasshopper's sake... Nancy Pelosi & Harry Reid exclaim in an interview with Larry King that the ant has gotten rich off the back of the grasshopper, and both call for an immediate tax hike on the ant to make him pay his fair share...... Finally, the EEOC drafts the Economic Equity & Anti-Grasshopper Act retroactive to the beginning of the summer, The ant is fined for failing to hire a proportionate number of green bugs and, having nothing left to pay his retroactive taxes, his home is confiscated by the Government Green Czar.... The story ends as we see the grasshopper finishing up the last bits of the ant's food while the government house he is in, which just happens to be the ant's old house, crumbles around him because he doesn't maintain it.. The ant has disappeared in the snow... The grasshopper is found dead in a drug related incident and the house, now abandoned, is taken over by a gang of spiders who terrorize the once peaceful neighborhood.
Reply