People participate in clinical research trials for a variety of reasons. In various phases of clinical research trials, volunteers can gain access to promising medication long before these compounds are on the market. In addition to gaining access to medication, volunteers also receive treatment from licensed physicians and are often eligible for compensation to assist with travel expenses, as well as medical services during the course of the study. At MediSphere Medical Research we feel it is paramount to provide quality research without compromising the safety and rights of our volunteers. Patients' rights and safety are protected in two important ways:
Any research center awarded a research grant from a pharmaceutical company must obtain approval to conduct the study from an Institutional Review Board. The review board is responsible for examining the study to ensure that the volunteers' rights are protected, and the study does not present any undue or unnecessary risk to the patient.
Anyone volunteering to participate in a clinical trial in the United States is required to sign an "Informed Consent" form. The purpose of this form is to provide details about the study, the risks associated with the study medication, and what procedures the volunteer will undergo during the course of the study. Volunteers considering participation in clinical research should discuss it with their primary care physicians or medical caregivers. Volunteers should not hesitate to ask questions when participating in a clinical research trial.
Criteria that would allow volunteers to participate are based on factors such as age, gender, type of disease, previous treatment history, and other medical conditions. It is important to not take rejection of participating personally Instead the criteria are used to identify appropriate volunteers and keep them safe.
A volunteer's role is important to researchers in understanding specific health issues. During gathering of general medical information, it becomes the volunteer's responsibility to provide accurate information about their health, medication, and family's medical history. All information obtained is held confidential and is used to properly qualify patients for a study. Once a volunteer qualifies for the study of interest and is enrolled, full participation of the following will aid in successful study results.
A Protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the volunteers as well as answer specific research questions, it describes what types of volunteers are needed, the schedule of tests, procedures and medications, and dosages and length of study.
Clinical Studies are conducted in phases. Each phase has a different purpose that helps scientists answer different questions:
Phase I Researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its Safety, determine the Dosage Range, and Identify Side Effects.
Phase II Researchers test the experimental drug or treatment on a larger group of people (100-300) so see if it is Effective and to further evaluate its Safety.
Phase III Researchers test the experimental drug or treatment to an even larger group of people (1,000-3,000) to confirm its Effectiveness, Monitor Side Effects, Compare it to commonly used treatments, and Collect information that will allow the experimental drug or treatment to be used Safely.
Phase IV Researchers conduct Clinical Trials to identify and evaluate the long-term effects of already approved new drugs and treatments over a lengthy period for a greater number of patients. Phase IV research takes place after the FDA approves the marketing of a new drug. Although the drug or treatment has previously been approved, studies are conducted to see if they can be used for other health indications. Through Phase IV Clinical Studies, new drugs can be tested continuously to uncover more information about efficacy, safety and side effects after being approved for marketing.
Clinical Trials that are Well-Designed and Well-Executed are the best approach for eligible volunteers to:
1. Myth: You have to quit the other medications you're already taking while you're participating in a clinical trial.
This may be true, depending on the clinical trial. Every trial has individual criteria for its participants, and medication history is definitely a factor that researchers consider when determining eligibility.
2. Myth: Clinical trials are expensive.
This is false. Travel to and from the appointment may not be covered, but the trials usually are. Typically clinical trials don't cost anything for the patient because they are federally or privately funded. Most health insurance plans also cover routine patient visits that are associated with the clinical trial. Additional research costs for things like blood tests and scans are often covered by the trial sponsor.
3. Myth: Once you start a clinical trial, you have to finish it.
This is false! Participants can drop out of clinical trials if they choose to. Follow-up visits are necessary to ensure the health of the patients, but not finishing a clinical trial is absolutely allowed.
4. Myth: You can be part of a clinical trial only if you live near a major hospital.
This, too, is false. There are clinical trials held out of smaller medical offices, although it's not as common. To help participants who live farther away, some trials assist in arranging transportation and even accommodations in hotels.
5. Myth: If you're part of the placebo group, you will not receive the same level of care as the treatment group.
This is false. Whether participants are on a placebo or the treatment, they will be receiving the same level of attention from the trial staff. Research coordinators and trial staff often don't even know which patients are receiving a placebo in order to ensure unbiased results. Regardless of which group the participant belongs to, research staff can recommend dropping out of the trial if the patient's conditions worsen or fail to improve.
6. Myth: You don't have to go to regular doctor visits if you're participating in a clinical trial.
This is also false! Clinical trials can't replace appointments with your regular doctor. You'll still need standard prescriptions, surveillance tests, and other procedures as you're going through the clinical trial. You'll also need to keep your regular doctor informed about your participation in the study.
7. Myth: Clinical trials last for months and months.
This is sometimes true. Some trials are only one to three months in duration. Others can be six to twelve months or longer.
8. Myth: You can't participate in a clinical trial if you're in remission at the time.
This depends on the study. Although many clinical trials are for patients with moderate to severe disease, not all studies are.
9. Myth: There is no information available to clinical trial participants on the earlier results of the study.
This is false. Information from earlier completed clinical trials should be accessible for patients of the current trial to review.
10. Myth: Participants cannot continue to use the study's drug or therapy after the trial ends.
This is sometimes true, depending on the sponsor of the study. Some allow participants to continue the treatment in an open-label extension study, while others may have to wait for approval from the FDA.
It is sometimes hard to understand Clinical Study Terms here are a few words and phrases you might hear:
• "Study-related medication"
Some studies that we conduct have a drug, developed by the pharmaceutical company, to be given to study participants. The drug that is distributed is only related to that particular study.
• "Study-related medical care"
This phrase refers to the medical attention you will receive that relates to the study you are involved in.
• "Physical exams"
This phrase describes the observational procedures of the body, done by a doctor - which may vary from study to study.
• "Laboratory (Lab) work"
This is i.e. blood draw, collection of urine and nasal cultures. It is sent to a lab to determine information relating to the study.
• "At no cost/charge"
All study-related procedures, office visits, study medications are provided at no cost/charge to you. Some additional examples of what is offered in a study include the following: study-related medical care, physical exams, and lab work.
• "No insurance required"
You do not have to have insurance in order to participate in a research study. If have insurance, neither you nor your insurance provider will be billed for the study-related care provided.
• "Compensation for time & travel"
This is the financial amount (money) you receive for participating in a study. The amount varies from study to study.
• "Informed consent"
This form is given to you prior to being in a study. It is detailed information regarding the study, the risks of participation, and the benefits, which can be used for you to help determine your participation.
• "Study Visit"
This is the appointment that is set up for you to come and participate in a study.
Not consuming any food or drink. At our research site, volunteers are sometimes required to fast prior to an appointment. This action helps us determine, for example, your cholesterol levels with better accuracy.