Sarah Bohnert was tired of her chronic headaches. So about 10 years ago, she decided to take part in a clinical trial. During the trial, she was diagnosed as a migraineur and given a triptan as a backup medication if the study drug didn’ t work. The triptan— not the trial drug— worked and gave Bohnert her first real moment of relief from headache. Now the accountant and mom is a 10-year veteran of clinical trials.
“ It wasn’ t the drug for the trial that was effective, but it was exciting for me,” she says.“ That’ s what’ s been valuable: Trial participation keeps me connected with doctors and the headache world.”
You’ ve probably seen a flyer in the doctor’ s office or heard a radio advertisement for a clinical trial. It may sound complicated and complex. But a clinical trial refers to any health-related research that follows a specific protocol. At any given moment, there are hundreds of headache-related clinical trials under way across the nation, says James Banks III, MD, of the Ryan Headache Center in St. Louis.“ Clinical trials really advance medical science,” Dr. Banks says.“ It’ s how we develop new medications and how we begin to understand a disease more effectively and thoroughly.”
The benefit for you: Participating in research can be a great way to get some extra medical attention, as well as contribute to medical science, but they may not be for everybody. Consider these questions about clinical trials to see if participation might be right for you.
What Is a Clinical Trial? Every drug or therapy seeking approval from the U. S. Food and Drug Administration( FDA) must go through clinical trials. In addition, some studies are conducted that do not include testing of an experimental or unproven therapy. For example, the American Migraine Study uses mail-in interviews to collect and analyze huge volumes of data about migraine patients to identify patterns of diagnosis, quality of life, prescription use, etc.
Funding for clinical trials may come from the federal government, including grants from government agencies such as the National Institutes of Health, the Department of
“ Ultimately, the patients’ health and well-being is of primary importance.”
Defense and the Department of Veteran’ s Affairs.
Independent research foundations, pharmaceutical and medical device manufacturers, or non-profit foundations( such as the National Headache Foundation) may also privately fund clinical trials.“ All clinical trials must go through a detailed review by an independent board before beginning, as an assurance that the study is ethical, appropriately designed and will not expose patients to any undue risks,” Dr. Banks says.“ Ultimately, the patients’ health and wellbeing are of primary importance.”
Once the experts give the study the green light, that’ s where you come in.
How Does a Clinical Trial Work? If you join a clinical trial, expect to first go through the informed consent process, a time when you will learn the highlights of the trial before you decide whether to participate. The physician or nurse involved in the trial will explain the details and then will provide an informed consent document with the main points as well as an exhaustive list of possible risks or side effects. As of March 7, 2012, the FDA now also requires that researchers let participants know that their clinical trial information will be entered into a databank maintained by the National Institutes of Health / National Library of Medicine. Before you sign your informed consent document, take the information home and read it thoroughly. Keep in mind that you don’ t have to participate and you can opt out at any time— even after the trial has begun, Dr. Banks says. Typically, volunteers are assigned to a specific cohort of patients for a“ double blind” trial. This means that some will receive the experimental treatment while others will receive an alternative treatment or a placebo, which looks similar to the experimental treatment but doesn’ t contain any actual medication. Neither the patient nor the researchers know who has received the experimental treatment( thereby creating a“ blinded” study) to eliminate the potential for a biased outcome, Dr. Banks says. All participants receive the same level of medical care throughout the study.
For more information about ongoing research or to participate in clinical trials, go to www. headaches. org / Clinical _ Trials.
Bohnert says several of her trials have been testing a new application or dosage for a medication.“ I just go in for an initial visit, receive the medication and treat one headache with it,” she says,“ then I come back for a follow up.” She’ s also been a part of longer-term studies that involved treating her headaches and keeping a diary for seven or eight months, along with periodic check-up appointments.
Rachel Stevenson, who works from home for a specialty health care company, is currently involved in a four-month clinical trial examining whether milnacipran, a fibromyalgia drug, might help chronic migraineurs like her. She’ s been taking the medication and keeping a diary, she says, and she feels like it’ s helping.
Whatever the parameters, Dr. Banks gives participants the same message as each trial begins:“ I can’ t promise this medication will work.”
Usually in regular patient care, when something isn’ t working, the doctor could change the dose or even the medication to potentially get better results. But not during a study.
“ Whether a specific treatment works or doesn’ t work, either way, that is important information,” Dr. Banks says.“ A clinical trial is a much more systematic way to evaluate the benefits of a medication.”
So you’ ve given researchers hours of your free time, which is already in short supply. You’ ve arranged for other parents to take the kids to soccer practice. You’ ve followed the protocol to a“ t.” But the trial offers you no relief. Is there anything else in this for you?
Why Would I Want to Do This? Beyond the opportunity to access a treatment that may help long before it’ s on the market, a study also puts you in touch with specialists in the headache research community. And it allows you to be evaluated by someone at the forefront of the subject area, Dr. Banks says. Physicians conducting research usually have more time to spend with their subjects than physicians in a clinical setting, and the appointments generally“ become much more educational for the patient,” he explains. Not only do study participants receive a lot of information and background about their particular condition, but they also get a variety of general health evaluations.
“ Each time, the researchers talk to you about how your headaches have been and different prevention possibilities,” Bohnert says.“ In addition, most studies involve a blood draw and EKG, so I get a mini checkup I don’ t have to pay for.”
Research subjects are often compensated for their time and effort. Bohnert pockets around $ 35 per doctor visit, although this certainly varies.“ It’ s not a lot of money,” Dr. Banks says.“ But it compensates them for their time and effort. It can be a lot of work to keep a diary and fill out all the forms.”
Stevenson says participating in clinical trials has taught her to take better care of herself.“ Migraine doctors encourage patients to track headaches in a diary, and I’ m not always that great about doing it. But because I’ m doing it for a study, I’ ve been better,” she says.“ It’ s important. I know they’ re looking at the data, and it’ s helped my own awareness of my headache patterns.”
Ultimately, clinical trial volunteers“ get to be part of advancing medical science,” Dr. Banks says.“ Many get a kick out of saying they helped bring a medicine to market. There’ s a sense of pride in that.”
What Are the Risks? Still, there’ s an element of the unknown in any experiment. But patient safety and well-being are paramount to the FDA,“ so lots of safety measures are built in even before trial enrollment,” Dr. Banks says. The health of potential participants is
From Test Tube to Medicine Cabinet
>> Bringing a new drug to market can take 12 to 15 years and cost more than $ 350 million.
>> About 99 percent of possibilities never make it to market. According to Drugs. com, an independent source for drug information, only one of every 1,000 compounds tested in the lab proceeds to human testing( and most never emerge from there).
>> Some researchers go through their entire career without ever developing a successful medication, reports James Banks III, MD. Their trials may come to a halt because the drug may not work, or it may not be effective in enough of the patient population to make producing it a wise business decision.
carefully evaluated, and they must meet certain standards before being accepted. Once the trial begins, each time a volunteer sees a doctor he or she is carefully questioned about problems or anything new since the last visit.
There may be more risks associated with earlier phases of clinical trials, which involve a new drug that has not yet been given to many people. Doctors can anticipate some
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