To test the effectiveness of a new medical treatment, drug, or device with patients, researchers conduct a scientific study called a clinical research trial. The Portland Clinic Research Department is currently participating in the following studies:
- Post-menopausal osteoporosis: A six-month study comparing two treatments for post-menopausal women between the ages of 45 and 80 who have decreased bone density.
- Heavy menstrual bleeding: A study of women 18-49 who have heavy bleeding three or more days per month. Participants must be willing to go off of hormones or contraceptives during study (12+ weeks).
- Severe Hot Flashes: A study of post-menopaulsal women between the ages of 40 and 65 who experience an average of at least seven daily episodes of hot flashes or night sweats that are severe enough to seek treatment.
If you think you might be a candidate for participating in one of these studies, please read carefully all of the information below.
ABOUT CLINICAL RESEARCH TRIALS
The medical world cares about the human condition. That is why researchers constantly look for better or new ways of treating illness and disease. They spend years doing laboratory and animal research to determine the general use and safety of a new treatment, but their discoveries cannot be put into general use until controlled testing has been done on actual patients.
The Food and Drug Administration (FDA) requires clinical research trials before it can approve a new treatment as safe and effective for public use. A clinical research trial studies the exact effects of the treatment on people. It may show that the investigational treatment is better than, as good as, or no better than the standard treatment for the same condition. Or it may confirm the discovery of a successful treatment of a disease for which there never had been a treatment at all.
A clinical research trial is a partnership and a commitment between doctors and volunteer patients. It is the final test in a series of many carefully controlled scientific studies that are done to improve the quality of life. It is the link between research and relief of human suffering.
Who conducts clinical research trials?
Pharmaceutical companies, research institutions, or other health organizations sponsor a clinical research trial. Sponsors are responsible for funding and for designing the trials protocol, the set of detailed guidelines that clinical investigators follow in order to conduct the same clinical research trial at several different locations. Trained doctors, nurses, and medical researchers conduct the trials.
What is a clinical research trial like?
Participating in a clinical research trial is much like a regular visit to a hospital, medical clinic, or doctors office, but with even greater personal attention. The success of any trial depends on its volunteers. Patients are treated professionally and with care.
What are the risks?
Risks vary from trial to trial. Unfortunately, no one can say with certainty what the risks of a particular trial might be. Although researchers expect certain results from each trial, the fact that a treatment is still being studied makes it impossible to rule out side effects or adverse reactions. While it is possible that some side effects could be permanent or even life threatening, most are temporary and will go away as soon as the treatment is stopped.
Are there requirements for volunteers?
Every clinical research trial attempts to answer some very specific research questions. To do this, each trial has very specific guidelines, which must be adhered to for the continuity and integrity of the study and its results. Each trial has certain requirements (for example: health, medication, and age), and volunteers must meet these requirements.
For the eligibility requirements for a particular trial, contact the research coordinator at the number listed at the end of this web page.
What is expected of volunteers?
The first responsibility of volunteers is to understand fully their commitment to the trial. The trial investigators and sponsor need volunteers to be at appointments on time, to follow instructions carefully, and especially to take any medication exactly as told. They need volunteers to take the trial seriously. Investigators need the full cooperation and participation of volunteers in order to collect the information necessary for a successful study.
What can volunteers expect from the clinical research trial team?
More than anything else, volunteers have the right to expect complete information about the trial. They should not participate in any clinical research trial unless their questions have been reasonably answered.
Volunteers will be given an informed consent form to read and sign. This is required by law to make sure they understand what is involved in a trial. It should include an honest discussion of potential risks and benefits.
Volunteers should also expect complete information about the schedule and duration of the trial, directions to the trial location, and the name of someone to contact with questions or problems.
Are volunteers protected?
As patients under doctor’s supervision, volunteers are protected by the same laws and ethics that normally regulate the medical profession. Informed consent helps protect volunteers by making sure they have been given all the necessary information about a trial. The FDA regulates clinical research trial advertisements to reduce misleading claims. It also requires an institutional review board to review the general progress of the trial.
Can volunteers change their minds after a clinical research trial starts?
Volunteers are always free to change their minds and stop participating in a trial at any time. They should keep in mind, however, that when even a few patients stop participating mid-trial (because of disinterest or other reasons), there may not be enough patients remaining to achieve reliable results.
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DEFINITIONS OF TERMS
Clinical research trial: A scientific study that tests the effectiveness of a new medical treatment, drug, or device with patients.
Clinical investigator: A medical researcher in charge of carrying out a clinical research trials protocol. This could be a doctor, nurse, pharmacist, or other health care professional.
Food and Drug Administration (FDA): The government agency that sets guidelines on the manufacture, testing, and use of drugs and medical devices. All drugs and medical devices must be approved by the FDA before they can be used by the general public.
Informed consent: The complete and open discussion of all procedures, benefits, risks, and expectations of a clinical research trial between clinical investigators and patients. The FDA requires all patients to sign an informed consent form before participating in a trial.
Institutional Review Board: A group of health care professionals, scientists, clergy and lay leaders, and members of the local community who are independent from the sponsor or research center and who must approve the research trial’s methods and goals before the research can begin. The board makes sure all FDA and protocol regulations are followed and reviews all trial activities, including recruitment and advertising and potential risks.
Investigational treatment: The drug or device being tested during a clinical research trial.
Pharmaceutical company: A business that researches, develops, tests, manufactures, and/or sells medical drugs and devices.
Protocol: A detailed plan carefully designed by a clinical research trial sponsor. It sets guidelines for a trial and usually involves several different trial locations.
Sponsor: The pharmaceutical company, research institution, or other health organization that funds a clinical research trial and designs its protocol.
Standard treatment: A treatment currently in wide use and approved by the FDA for a particular disease or illness. In some trials involving new investigational treatments, there may be no pre-existing treatment at all. In these cases, the lack of any treatment is itself considered the standard treatment. Generally, the investigational treatment is hoped to be safer and more effective than the standard treatment.
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MAKING THE DECISION TO PARTICIPATE IN A CLINICAL RESEARCH TRIAL
There are two reasons to participate in a clinical research trial: to help yourself and to help others.
It is possible the treatment being tested will improve your health. A new drug or new procedures may reduce pain or perhaps even cure your illness. All clinical research trial patients receive a great deal of personal medical attention.
You may also decide to participate in a clinical research trial for the satisfaction that comes from being a part of scientific research. Many people hope for a breakthrough treatment that will make coping with an illness easier or eliminate it altogether. Clinical research trial volunteers help make those discoveries available to people all across the country and around the world.
Being a volunteer is a serious commitment.
Do not join a clinical research trial out of curiosity. Deciding to participate in a clinical research trial means weighing possible benefits against possible risks. You should only make the commitment to participate in a clinical research trial after you have carefully discussed all the facts with the research office coordinator and/or your family doctor and considered your own reason for participating. THINK IT OVER CAREFULLY.
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QUESTIONS TO ASK YOU DOCTOR BEFORE PARTICIPATING IN A CLINICAL RESEARCH TRIAL
- What is the purpose of the trial?
- What treatments will be done and how?
- How will patient safety be checked?
- What are the possible side effects and risks of this treatment?
- How could this treatment benefit me?
- What treatments, other than the one being tested, are available for the same condition?
- How will the trial affect my daily life?
- How long will the trial last?
- Who is sponsoring the trial?
- Will I have to pay for anything?
- What happens if I am harmed by the trial?
- Will I be able to stay on this treatment when the trial is over?
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CONTACTING THE PORTLAND CLINIC RESEARCH DEPARTMENT
For more information or to enroll as a volunteer, please call the number below. Leave a message, and we will call you back.
503-221-0161 x 2107
You can also reach us by e-mail: research@tpcllp.com
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