STORY BYFrom popular pain relievers to niche cancer drugs; from robotic surgery to nanotechnology, almost every medication and treatment available today has gone through human testing in a clinical trial.
A clinical trial is a scientific research study in which people participate to help physicians find new or better ways of treating patients. Most clinical trials test a new drug or new medical intervention and its ultimate value in the prevention, diagnosis or treatment of a disease, disorder or illness.
Clinical trials are essential for studying safety and efficacy; physicians and researchers depend on them. They provide the best information on how to treat patients suffering from cancer to the common cold.
But, we patients depend on them, too. Clinical trials help us make intelligent decisions about our own care.
The first clinical tests of a new drug or treatment method focus on safety (Phase I). In Phase I trials, investigators search to find the safest possible dose of the drug for humans, while evaluating its toxicity and side effects in a small group of people.
Researchers move into Phase II trials to further evaluate the safety and efficacy of the drug’s dose range by testing the drug in a larger group of people.
Phase III trials are critical. They tell researchers if this new drug will actually work as an effective form of treatment for a specific disease or illness. These randomized trials include larger groups of people with one group receiving the standard treatment or a placebo, while the other group receives the new drug.
Does a “randomized trial” mean just “any old trial”?
Is a double-blind study more clueless than a single-blind study?
How many “arms” are found on a large-scale “multi-site trial”?
What is the appropriate protocol for a “protocol”?
Brush up on your clinical trial vocabulary so that you’ll be better informed when you read about new drugs or treatments: Clinical Trials Glossary of Terms
There are other types of clinical trials beyond testing drugs and treatments. There are clinical trials that look at screening and early detection of a disease or illness. Quality of life trials may study depression or behavior in patients with a chronic illness or seek to improve their quality of life. Prevention trials explore avenues to prevent disease in people who have never had the disease or to prevent a disease from coming back in those who have.
With some basics of clinical trials behind us, HealthLeader spoke with two experts to help you decide if participating in one is right for you.
“A clinical trial is important because this is the most rigorous way investigators can measure the usefulness of an intervention in medical care, and it allows for a structured way of gathering and interpreting information,” says Pablo Okhuysen, MD, professor of internal medicine in the Division of Infectious Diseases at The University of Texas Medical School at Houston and director of the Clinical Research Unit and is co-director of the Center for Clinical and Translational Sciences.
Clinical trials help bring new drug therapies from the laboratory bench to the patient’s bedside, and Okhuysen says it would be impossible for medical therapies to advance at all without them.
Clinical trials are necessary to show if a new drug or new intervention is both safe and effective. To quickly advance promising therapies and novel approaches, researchers need volunteers.
In their ability to move science and medicine forward for the good of society and the health and well-being of the patient, it’s hard to overstate the importance of clinical trials.
“The benefit for science and medical care is tremendous because through these clinical trials breakthroughs are made and medical care advances,” says Okhuysen, who also sees patients and conducts research at Memorial Hermann – Texas Medical Center. “From the perspective of society, clinical trials can be of use in improving the health of the population in general. To the individual patient, some clinical trials may offer treatment alternatives that the patient otherwise wouldn’t have had access to because they are still investigational.”
By participating in a clinical trial, you take an active role in determining the next phase of your health care, not to mention helping future generations through your contribution to medical research.
That’s a tricky question because all clinical trials have specific criteria to help the researcher and study staff determine who the best candidates would be for their trial, which is why Okhuysen stresses that there really isn’t one particular profile that fits all patients or all studies.
“Clinical trials are really of an enormous variety, and there isn’t one particular profile of a participant that is applicable to all research,” he says. “Each study has its inclusion and exclusion criteria, and these need to be discussed with the investigator to see if it is a good fit for you.”
Ask questions! The single most important thing you can do before volunteering for a clinical trial is to ask questions.
“It’s very important to ask questions and to make sure that you have all the information about the study before you decide to join,” says Catharine “Catey” Carter, RN, clinical research coordinator in the Office of Research. “The study staff will make sure that you meet all the inclusion and exclusion criteria and that you will be a good candidate for the trial, but it is truly up to you, the volunteer, to decide to join the study.”
A great time to ask questions is during the informed consent process where the coordinator or research nurse explains all the important details about the clinical trial to the volunteer. Find out as much as you can about the study with questions like these.
“Knowing the answers to these things may help you decide whether this clinical trial fits with your needs or not,” Okhuysen adds.
If you’re still undecided, try making a pros and cons list.
The side effects and risks of a drug are all explained during the informed consent process, as well as what a subject should do in case of an emergency or injury, Carter says. A 24-hour contact number is given to each subject to call any time an adverse event occurs or when any questions arise while participating in a clinical trial.
“As in any other medical intervention, there is always the possibility of a risk by participating in a clinical trial,” Okhuysen says, adding that additional efforts are made to minimize the risks of disclosure of protected health information. “The risk for the person is really individualized. As a consumer in a clinical trial, you should be able to discuss the pros and cons of participating in a particular study with your investigating physician or investigative team.”
There are several resources available about participating in clinical trials, and you can begin by researching on the Internet.
“One way to find a study is to log on to the Web at ClinicalTrials.gov, enter the diagnosis, and all of the studies relating to the diagnosis and their locations will show,” Carter says. Another way to find local trials here at the UT Health Science Center is on the Clinical Trials link on HealthLeader.
If you have trouble finding relevant studies on the Web, Carter advises using your physician as a resource for a referral to a clinical trial that might fit your needs.
“A lot of times, patients will come in to their physician, and the physician may know about a study going on,” she says. “The subject would be screened by the research staff to see if he or she qualifies by meeting the inclusion criteria. Then, the subject would be approached about the study to see if he or she might be interested in joining.”
Additionally, look for advertisements or literature in waiting rooms of doctor’s offices or medical clinics – a good resource for finding out about clinical trials in your area. Then, when it’s your turn to see the doctor, ask about the study flyer to see if the research is relevant to your needs.
Okhuysen adds that some patients find out about clinical research by participating in disease specific support groups. “For example, if you have an autoimmune disease, you might want to consult with your support group,” he says.
“Clinical research is really done in all phases,” Okhuysen explains. “Some are done to prevent disease. Some are done to treat it at an early stage, and some are done at later stages of disease. The best advice for patients is to discuss these options with their physician to best do a fit with their disease state.”
To learn more about clinical trials at The University of Texas Health Science Center at Houston or to volunteer as a clinical trial participant, visit www.uthouston.edu/clinicaltrials.
Last Updated: 5-14-2008Editorial Board | Legal Disclaimer | Privacy & Security | Contact Us
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Dr. Pablo Okhuysen is professor of internal medicine in the Division of Infectious Diseases at the UT Medical Schooland director of the Clinical Research Unit and is co-director of the Center for Clinical and Translational Sciences.
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