24 Jan FAQs about Clinical Research
Learn about Medical Research
What is a clinical study?
A clinical trial (also called clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether investigational treatments or new ways of using known therapies are safe and effective under controlled conditions.
Clinical research studies (sometimes called trials or protocols) are a means of developing new treatments and medications for medical illnesses and diseases. There are strict medical and ethical rules for clinical trials, which are established by the National Institutes of Health and the U.S. Food and Drug Administration.
What are Phase I, Phase II and Phase III studies?
The Phase 1 study is used to learn the “maximum tolerated dose” of a drug that does not produce unacceptable side effects. Patient volunteers are followed primarily for side effects, and not for how the drug affects their disease. The first few volunteer subjects receive low doses of the trial drug to see how the drug is tolerated and to learn how it acts in the body. The next group of volunteer subjects receives higher doses.
The Phase 2 study involves a drug whose dose and side effects are well known. Many more volunteer subjects are tested, to define side effects, learn how it is used in the body, and learn how it helps the condition under study. Some volunteer subjects may benefit from a phase 2 study.
The Phase 3 study compares the new drug against a commonly used drug. Some volunteer subjects will be given the new drug and some the commonly used drug. The trial is designed to find where the new drug fits in managing a particular condition. Determining the true benefit of a drug in a clinical trial is difficult.
What kinds of clinical trials are there?
- Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
- Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
- Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
- Screening trials test the best way to detect certain diseases or health conditions.
- Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
Why should I participate?
People participate in clinical research for a variety of reasons. Volunteers can possibly gain access to potentially promising medicines long before they are approved for use by physicians and patients. The standards required of medical professionals performing medical research are rigorous and result in patients receiving excellent care during the course of the study, with an added benefit that it will be at no financial cost to the study participant.
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. Clinical trials that are well-designed and well-executed are the best approach for participants to:
- Play an active role in their own health care.
- Gain access to investigational medications.
- Help others by contributing to medical research.
The health of millions has been improved because of advances in science and technology, and the willingness of thousands of individuals like you to take part in clinical research. The role of volunteer subjects as partners in clinical research is crucial in the quest for knowledge that will improve the health of future generations.
What is the downside to clinical research participation?
There are also risks to clinical trials:
- As with all approved medications, there may be side effects.
- The treatment may not be effective for the participant.
- The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements
Who can participate in a clinical trial?
All clinical trials have guidelines about who is eligible to participate. The use of eligibility criteria is an important principle of medical research that helps to produce interpretable and clinically-relevant results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria”. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, other medical conditions, and other clinically-relevant factors. In order to determine effectiveness and tolerability, individuals with the disease or condition in question must be medically-stable to be eligible for study participation.
What are the benefits of participating in a study?
There are lots of reasons to participate, but even more benefits. Over the years we have heard from many of our patients as to why they volunteered. Overall, they saw benefit as stronger than any risk. For the most part, comments about the benefits included:
- VIP treatment: We strive at being the very best at customer service: no long waits, prompt responses to questions and a true focus on your care. We also promise you:
- Convenient appointment times
- Appointments scheduled without delay
- Ample appointment time
- Confirmation calls for next appointments
- Follow-up calls, cards, letters
- Transportation stipend or provided outright
- Notification of any laboratory, electrocardiographic, or other findings and updates
- Complete physical examination
- Complete and thorough diagnostic assessment
- Personalized care: Our process is more thorough than your basic doctor’s visit. We dig deep into your medical history and perform a full battery of screening tests, not only because we care but because the study protocols demand it! Clinical oversight means we take an interest in your total health, not just the disorder that brought you in the door. Because we screen for a variety of things, for example blood pressure, we can catch any other health concerns right away.
- No out-of-pocket costs: You get support and medical supervision at no cost, whether or not you have insurance is not an issue.
- Possible compensation for travel and inconvenience: Some of our studies provide a small reimbursement for your travel expenses.
- Opportunity to benefit society and to help others: Your participation is vital to finding answers and solutions – perhaps for your own children.
- Increased understanding about disease process/illness: Our team of experts can fill in some of the blanks left by other providers. As leaders in the field of Alzheimer’s research, we are intimately involved with all aspects of the disease from diagnosis to progression to options for treatment
What happens when I enroll in a clinical study?
During your first call with us, our staff will tell you about everything that will happen and give you a list of specific information you will need to bring with you. Your first appointment takes about three to four hours but subsequent visits only last 45 minutes to an hour. During that first visit, the research physician will go over your medical history with a diagnostic evaluation that includes a physical exam, labs, ECG, urinalysis, and urine drug screen to determine eligibility. The next visit is a baseline visit where you are randomized to the control or drug group.
What is randomization?
Randomization is when two or more alternative treatments are selected by chance, not by choice. The treatment chosen is given with the highest level of professional care and expertise, and the results of each treatment are compared. Analyses are done at intervals during a trial, which may last years. As soon as one treatment is found to be definitely superior, the trial is stopped. In this way, the fewest number of patients receive the less beneficial treatment.
What are single-blind and double-blind studies?
In single- or double-blind studies, you know all about the medication being tested, but you do not know which treatment group you are assigned to. Studies are blinded to remove bias, so that no one (doctors, nurses, or patients) can influence the results. This allows scientifically accurate conclusions. In single-blind (“single-masked”) studies, only the patient is not told what is being given. In a double-blind study, only the pharmacist knows; the doctors, nurses, patients, and other health care staff are not informed. If medically necessary, however, it is always possible to find out what the patient is taking.
What is a research protocol?
A protocol is a set of rules and guidelines that the clinic follows in order to ensure compliance with the pharmaceutical company or university running the research study as well as compliance with bureaucratic governmental regulations. They often include safety guidelines, information about the drug, instructions for the clinic regarding the dispensing of medication, other procedures, and rules that the patient has to follow in order to continue to be a part of the study.
What is a placebo?
The placebo is the control; it is identical to the medication under study but has no active ingredient. The use of a placebo is to help determine if the test drug is effective or not. Because you might be on placebo during the study, our physician provides two to three months of free aftercare treatment for you in order to ensure that you get to the quality of life you desire regardless of whether or not the study was effective for you.
Where do the ideas for trials come from?
Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about a new treatment, its risks and how well it may or may not work.
Who sponsors clinical trials?
Clinical trials are sponsored or funded by a variety of organizations such as universities, medical institutions, foundations, and pharmaceutical companies, in addition to foundations, insurance companies, and federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran’s Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.
How do I know that the study is safe?
Clinical studies go through a rigorous process with thorough oversight that includes ethical review and approval by an Institutional Review Board (IRB), FDA review of protocol, drug and data, as well as local clinician determination. The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants’ names will remain secret and will not be mentioned in these reports.
Safety is our first priority! All participants are monitored closely by a medical research physician and his team. We complete a thorough evaluation of each participant’s medical condition, including what medications are currently being taken. Participants are monitored very closely to keep any negative outcomes to the very minimum.
What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant’s native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
Are there risks involved in participating in clinical research?
Risks are involved in clinical research, as in routine medical care and activities of daily living. In thinking about the risks of research, it is helpful to focus on two things: the degree of harm that could result from taking part in the study, and the chance of any harm occurring. Most clinical studies pose risks of minor discomfort, lasting only a short time. Some volunteer subjects, however, experience complications that require medical attention. The specific risks associated with any research protocol are described in detail in the consent document, which you are asked to sign before taking part in research. In addition, the major risks of participating in a study will be explained to you by a member of the research team, who will answer your questions about the study. Before deciding to participate, you should carefully weigh these risks. Although you may not receive any direct benefit as a result of participating in research, the knowledge developed may help others.
What safeguards are there to protect participants in clinical research?
There are many safeguards that protect the safety and rights of volunteer subjects. These safeguards include:
- The Ethical Review Process. As in any medical research facility, all new protocols must be approved by an institutional review board (IRB) before they can begin. The IRB, which consists of medical specialists, statisticians, nurses, social workers, and medical ethicists, is the advocate of the volunteer subject. The IRB will only approve protocols that address medically important questions in a scientific and responsible manner.
- Informed Consent Procedures. You must be educated about the program (informed) in order for you to be able to say yes (consent) to participate.
Does a participant continue to work with a primary health care provider while in a clinical trial?
Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. We do not take the place of your regular doctor and encourage you to continue your regular visits with your primary care doctor and other specialists you see. By having your health care provider work with the research team, we can ensure that other medications or treatments will not conflict with the protocol.
The good news is that our team of experts can fill in some of the blanks left by other providers. As leaders in the field clinical trials we are intimately involved with all aspects of your disease/disorder from diagnosis to progression to options for treatment.
Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
Billing and Insurance
What if I don’t have insurance? If I have insurance, are you going to bill them?
It is not necessary to have medical insurance to participate in our program. There is:
- No cost,
- No bill,
- No co-pay, and
- Not even a donation.
What if I am enrolled under the Affordable Care Act?
Many people who have recently obtained health insurance under the Affordable Care Act have been misguided regarding their health coverage. If you are suffering from symptoms related to depression, insomnia, anxiety, fibromyalgia, ADHD, HSDD, or PTSD, you are not necessarily better off under the Affordable Care Act. The fact of the matter is that just because you have health insurance doesn’t mean you have coverage for your emotional health.
Clinical research is still a great option for those people who are looking for low cost solutions to relieve them of their health symptoms. At a clinical research facility, the physician meets with the patient for extended periods of times and at greater frequency. Clinical research patients have the added benefit of confidentiality with employers and insurance companies, completely voluntary appointments, specialized treatment with a physician, and no-cost solutions to their health problems. The individual care and attention provided by research clinic physicians like that of Dr. Sambunaris at the Institute for Advanced Medical Research are unparalleled by typical physician offices. Dr. Sambunaris works with his patients throughout the study, and also provides two to three months of free, individualized aftercare treatment for his patients.
Is there compensation?
Our studies do not pay you to be a participant. However, some studies do offer gas cards in order to ease the burden of travel expenses to and from the clinic. You are also receiving two to three months of free aftercare treatment with our physician as a “thank you” for participating in the study.
What’s holding you back – questions? Second thoughts?
I don’t think I have the time to commit to a study. Who wants to drive all over Atlanta in this traffic?
We understand – we drive in Atlanta traffic every day too! That’s why we are conveniently located just a half mile off GA 400, with plenty of free parking, and first floor access right in Alpharetta.
I am already feeling overwhelmed. I am not sure I can add one more thing on my to-do list.
It is natural to feel a loss of control with a new diagnosis or when finding yourself as a caregiver. The good news is being part of a clinical trial lets you take back control and be an active participant in achieving your best life.
I don’t know anyone else who has done a clinical trial before; I am feeling a little unsure about the process.
Being an educated participant or consumer is the first step in the process. The truth is that clinical trials are not a commonplace event in the lives of most people. Our team has been conducting clinical trials for new drugs for over two decades with tremendous success; we take pride in playing an important role in the advancement of medical research. We are trying hard to get awareness and we appreciate your help in getting the word out to the community that resources are available!