FAQ

Before you decide to participate, volunteer for research, or discard the idea entirely, be sure to read over all of the information supplied.

Ask questions and make sure you make a well-informed decision based on facts and what is right for you.

Clinical trials facilitate the development of new medications and medical devices. Clinical trials help everyone who has, or may someday have, a particular illness or condition by serving as a proving ground for potentially helpful treatments. Volunteer clinical trial participants are vitally important to this research. The U.S. FDA (and comparable regulatory authorities in other countries) analyzes data gathered from thousands of clinical trial volunteers before deciding whether or not to approve an investigational new drug or medical device to be sold in the U.S.

Each clinical trial protocol has a list of criteria that each participant must meet (inclusion criteria). Every potential study participant receives the same high level of care during a comprehensive screening process which includes:

• telephone/internet pre-screening questions
• medical history
• current medications
• screening exams such as lab tests, EKG, and physical exam
• study-specific diagnostic tests such as X-rays and MRI

In addition, the following may also be required:
• a copy of your medical records
• approval by your personal physician

The goal of our careful screening process is to ensure that you meet the study’s enrollment criteria. The enrollment criteria are chosen by the developers of the protocol (study plan) for the safety of the study participants and to ensure that the study produces accurate, high-quality data.

In deciding whether to participate, read the informed consent form and ask questions. Be sure you evaluate the following:

• the purpose of the study, the type of investigational medication, and the study procedures

• the study design, including the number and frequency of study visits (appointments) and your ability to adhere to the visit schedule

• the total length of the study and your expected availability to complete the trial

• the location of the research facility and your available transportation

• any costs associated with trial participation versus any financial compensation received for participating

• any potential discomforts/risks versus potential benefits of participating

The Food and Drug Administration (FDA), and like similar regulatory authorities in other countries worldwide, are charged with ensuring the safety and effectiveness of all prescription drugs marketed in the U.S. Before the FDA gives the drug manufacturer approval to market a new drug, it considers two primary points:

• whether the clinical trials provide substantial evidence that the drug is effective

• whether the clinical trials show that drug is safe under the conditions outlined in labeling

Ultimately, what the FDA considers is whether the benefits of the drug outweigh its risks.

Informed consent refers to the process by which potential volunteer study participants learn the details about the clinical trial. Volunteers must be provided all known facts about a trial prior to giving consent to participate, including details about the investigational drug or device and possible risks and benefits. The informed consent form must be signed by the participant prior to study-specific screening procedures. In a sense, the informed consent process continues throughout the clinical trial, as participants are promptly informed when any new information becomes available which might affect their decisions about whether to continue in the trial or not. When significant new information becomes available or the study protocol is changed, study participants will be required to sign a revised informed consent form in order to continue in the trial. Each study participant will receive a copy of any informed consent document he/she has signed.

Clinical trial protocols are developed to ensure that patients are not put at undue risk. These protocols are carefully reviewed by a committee of experts and lay persons, called an Ethics committee, before testing can begin. As a volunteer, you have the right to refuse treatment at any point in the clinical trial and leave the trial at any time and for any reason.
Each clinical trial has guidelines for patients based on specific factors, such as age, type of disease, medical history and current health. Depending on the trial, sponsors may seek healthy individuals or those with the particular illness under study. Inclusion and exclusion criteria are used to determine which participants are chosen for the trial.
Phase II, Phase III, and Phase IV clinical trials, the types conducted by Better Health Clinical Research, are generally done on an outpatient basis. The patient lives at home, continues his or her regular activities, and visits the study site periodically as required by the protocol (study plan). Study visits are often every week or two in the beginning of a study, and as the trial progresses, the time between visits may extend to a month or so. A study visit is very similar to a doctor’s appointment, usually lasting 30 minutes to 2 hours depending on the trial and the visit, and includes many of the same procedures such as blood pressure and pulse measurements, urine sample collection, blood draws at some visits, physical exams by the doctor at some visits, review of medications and symptoms, and completing questionnaires about your pain and how well you feel the study drug is working to relieve your pain.
At its most basic level, a clinical trial is where volunteer patients are given investigational, or test, treatments, and doctors collect information about how the treatment affects study patients. In some clinical trials, some patients do not actually receive the test treatment, but instead receive a placebo (“sugar pill” or “dummy pill”) or standard treatment as part of the “control” (or “comparison”) group. Each patient’s progress is followed closely by doctors and study coordinators who will ask if you are experiencing any side effects and if you have added, stopped, or changed any of your other medicines. They may also measure your vital signs, perform EKGs, collect blood/urine samples and give you questionnaires to complete about your treatment. Our site is one of many in the country or around the world conducting each trial, and the data collected from each of the hundreds or thousands of patients in the trial are compiled and systematically analyzed by the Sponsor and presented in the form of reports to the FDA (Food and Drug Administration).
For almost all clinical trials, the costs are paid entirely by the Sponsor of the trial, usually the company that wants the FDA to give them permission to market the drug. Insurance providers are NOT billed for clinical trial costs, and there is no cost to the patient either. The Sponsor pays Better Health Clinical Research to conduct the trial, and Better Health Clinical Research pays its staff and doctors. The study medication is provided free of charge to the patient, and in many cases, the patient also receives a stipend (payment) to compensate for his/her time and travel to the site.
There are many individual and personal reasons for participation such as appreciation for the benefits such involvement could have for future generations. Many patients are happy to be assisting in the process that discovers more successful medicines, which at times benefit people with serious, painful, or life-threatening conditions. Investigational drugs in clinical trials today may go on to become the “miracle” drugs of ‘tomorrow’, and benefit you or your loved ones. For some patients who have tried all of the standard treatments for their condition with little improvement, clinical trials offer the possibility of access to new treatments several years before they become available on the market. For those who do not have health insurance or are “underinsured,” some find that the study-related medical care is a great benefit of clinical trial participation. Others enjoy the social interaction with the study staff and find the experience of clinical trial participation rewarding, filling a gap in their lives.
Strict guidelines are followed and experts review the trials to ensure patients are not subjected to undue risk. However, all trials involve some degree of risk, as do all medications including those purchased over-the-counter or prescribed by your doctor.
Most Phase II, Phase III, and Phase IV clinical trials, the kinds conducted by Better Health Clinical Research, range in length from several months to several years and require periodic study visits which are most often weekly or monthly, depending on the trial, the overall length of the trial, and the stage of the trial – visits are usually more frequent in the beginning.
You are provided with information about the trial in the informed consent document, which you are encouraged to read carefully, ask as many questions as you like, and you may take the informed consent home to discuss with family, friends, or your doctor before deciding whether to sign it and participate in the clinical trial. During a pre-screening, usually by telephone, you may be asked a number of questions about your current health and medical history to determine if you meet the eligibility criteria for the study. You will also be asked to sign an Authorization to Release Medical Records form so that we may request a copy of your medical records from other doctors you see frequently. At the screening visit, when all of your questions have been answered and you have decided that you want to participate in the trial, you will sign the informed consent document. The study coordinator and/or study doctor will sign it also, and you will receive a copy of the signed form to keep. A detailed medical history record will be created, and all of the medications you currently take will be recorded. Most screening visits include measurement of height, weight, and vital signs, an EKG (electrocardiogram), and blood and urine tests. You may be asked to complete some questionnaires about your medical condition and/or pain. After all of the test results have been received, you will be contacted, and if you have met all of the criteria to participate, your next study visit will be scheduled.

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