Frequently Asked Questions

Before you volunteer for a research study, be sure to ask plenty of questions.  Informed consent isn't just a document you read and sign once, it is a ongoing process.  Below are some questions and answers to frequently asked questions from people interested in joining a research study.  Please let me know if you have any more questions!


What is a Clinical Trial?

Medical advances can only be made through research. Clinical trials, also called medical research or drug studies, are one important way in which progress is made. They are planned investigations involving patients, which are usually designed to test new therapies. These therapies may include new combinations of current treatments or different ways of prescribing them to see if they can be made more effective or have their side effects reduced. Each study is designed to answer scientific questions and to find new and better ways to help patients. The results help to determine what the best treatments are and help improve care for patients in the future. Before a new treatment is tried with patients, it is carefully studied in the laboratory. This research points out the new methods most likely to succeed and, as much as possible, shows how to use them safely and effectively. But, this early research cannot predict exactly how a new treatment will work with patients. With any new treatment, there may be risks as well as possible benefits. There may also be some risks that are not yet known. Clinical trials help us find out if a promising new treatment is safe and effective for patients. During a trial, more and more information is gained about a new treatment, about the possible risks and about how well it may or may not work. Standard treatments, the ones now being used, are often the base for building new, hopefully better treatments. Many new treatments are designed based on what has worked in the past, in efforts to improve on this.

Why should I participate?

There are many reasons people take part in clinical trials. As a volunteer in a clinical trial, you are participating in the development of medical therapies - therapies that may offer better treatment and even cures for life threatening diseases and chronic illnesses. People volunteer to participate in clinical trials for a number of reasons. You may get involved in a clinical trial because you simply want to contribute to a research effort that may help others; you may get involved because you are suffering from a disease or condition for which a good treatment does not currently exist; you may get involved hoping to improve the medical care you receive. If you do not have health insurance, clinical trials are a way to receive study-related medical care. Based on what researchers learn from laboratory studies, earlier clinical studies, and standard treatments as well, they design a trial to see if a new treatment will improve on current treatments. The hope is that it will. Often researchers use standard treatments as the building blocks to try to design better treatments. Although there is always a chance that a new treatment will be disappointing, the researchers involved in a study have reason to believe that it will be as good as, or better than, current treatments. The patients in a clinical trial are among the first to receive new research treatments before they are widely available. How a treatment will work for a patient in a trial can't be known ahead of time. Even standard treatments, although effective in many patients, do not carry sure benefits for everyone. But, patients should choose if they want to take part in a study or not only after they understand both the possible risks and benefits The patients who take part in clinical trial procedures that do prove to be better treatments have the first chance to benefit from them. All patients in clinical trials are carefully monitored during a trial and followed up afterwards. They become part of a network of clinical trials around the country. In this network, doctors and researchers pool their ideas and experience to design and monitor clinical studies. They share their knowledge from many specialties. Patients in these studies receive the benefits of their expertise and receive care from a special research team. Through new programs, community hospitals and doctors are also coming more and more into the research network.

Are There Risks or Side Effects in Clinical Trials?

Yes. The treatments used in clinical trials can cause side effects and other health risks depending on the type of treatment and the patients condition. Side effects vary from patient to patient. Because clinical trials are research into new areas of treatment, the risks involved are not always known ahead of time, though efforts have been made to find out what they might be. For this reason, trials can carry unknown dangers and side effects as well as hoped-for benefits. Patients need to know what is involved in a study-what side effects may be expected-and, as much as possible, what unknowns or uncertainties they may be facing. Your doctor or nurse will tell you about the treatments being tested and will give you a form to read that discusses the risks and hoped-for benefits. If you agree to take part, you will be asked to sign a form, called the informed consent form. Before you sign, be sure you understand what risks you face. Ask the doctor or nurse to explain any parts of the form or trial that are not clear. If you do not want to be in the trial, you may refuse. Even if you sign the form, you are free to leave the trial at any time and can receive other available medical care.
What Is Informed Consent?

Informed consent, a key part of a good trial, is required in studies that are federally regulated or funded as well as by many state laws. Informed consent means that as a patient, you are given information so you can understand what is involved in a trial, including its potential benefits and risks, and then decide freely to take part in it or not. The nature of the treatment is explained by the doctors and nurses in the trial. You are given an informed consent form to read and consider carefully. Ask any questions you may have. Then, if you agree to take part, you can sign the form. Of course, you can also refuse. The informed consent process is an ongoing process. If you enter a trial, you will continue to receive any new information about your treatment that may affect you willingness to stay in the trial. Signing a consent form does not bind you to the study. You can still choose to leave the study at any time.

Can You Leave a Trial at Any Time?

Yes. Just as you can refuse to join a study, you may leave a study at any time. Your rights as an individual do not change because you are a patient in a clinical trial. You may choose to take part or not, and you can always change your mind later, even after you enter a trial. You may also refuse to take part in any aspect of the research. If you have questions at any time about any part of the study, be sure to ask your doctors. If you are not satisfied with the answers, you may consider leaving the study. If you decide to leave, it will not be held against you. You can freely discuss other possible treatments and care with your doctors and nurses. 

What Protection Do You Have as a Patient in a Clinical Trial?

The ethical and legal codes that govern medical practice apply to clinical trials. In addition, most clinical research is federally regulated or federally funded (at least in part), with built-in safeguards to protect patients. These safeguards include regular review of the protocol (the study plans) and the progress of each study by researchers at other places. For example, federally funded and federally regulated clinical trials must first be approved by an Institutional Review Board (IRB) located at the institution where the study is to take place. IRBs, designed to protect patients, are made up of scientists, doctors, clergy and other people from the local community. An IRB reviews a study to see that it is well designed with safeguards for patients and that the risks are reasonable in relation to the potential benefits. Federally supported or regulated studies also go through reviews by a government agency, which sponsors and monitors many trials around the country. Any well run clinical trial, whether federally supported or not, is carefully reviewed for medical ethics, patient safety, and scientific merit by the research institution. Every study should provide for monitoring the data and the safety of patients on an ongoing basis. Informed consent is also an important process that helps to protect patients. After patients join a clinical trial and it progresses, the doctors report the results of the trial to scientific meetings, to medical journals and whose articles are approved by experts, and to various government agencies.

How Are Clinical Trials Conducted?

The doctors who conduct a clinical trial follow a carefully designed treatment plan called a "protocol." This spells out what will be done and why. Studies are planned to safeguard the medical and psychological health of patients as well as to answer research questions. Some clinical trials test one research treatment in one group of patients. Other trials compare two or more treatments in separate groups of patients who are similar in certain ways, such as the extent of their disease. This way, the treatment groups are alike and the results from each can validly be compared. One of the ways to prevent the bias of a patient or doctor from influencing study results is "randomization." If a patient agrees to be randomized, this means he or she is selected by chance to be in one group or another. The researchers do not know which treatment is best. From what is known at the time, any one of the treatments chosen could be of equal benefit to the patient. If a treatment in a trial is not helping the patient, the patient's doctor can decide to take him or her out of the study. Of course, the patient can decide to leave, as well, and still receive other available care. There are regular reviews of the results of a trial and the information is shared. This is important, because if a treatment is found to be too harmful or not effective, it is stopped. Also, when there is firm evidence that one method is better than the others in a study, the trial is stopped and all patients in the trial are given the benefit of the new information. Such information may help present and future patients. Throughout a clinical study, a patient's personal doctor will be kept informed of the patient's progress. Patients are encouraged to maintain contact with their referring doctors.

How Are Trials Divided Into Phases?

In a Phase I study, a new research treatment is given to a small number of patients. The researchers must find the best way to give a new treatment and how much of it can be given safely. They watch carefully for any harmful side effects. The research treatment has been well tested in laboratory and animal studies but no one knows how patients will react. Phase I studies may involve significant risks for this reason. Phase II studies determine the effect of a research treatment. Each new phase of a clinical trial depends on and builds on information from an earlier phase. If a treatment has shown activity against the disease in Phase II, it moves to Phase III. Here it is compared with standard treatment to see which is more effective. Often researchers use standard therapy as the base to design new, hopefully better treatments. Then in Phase III, the new treatment is directly compared to the old one. In Phase IV studies, the new research treatment becomes part of standard treatment in patient care.
How Do I Participate?

Please feel free to call our office at 501-227-6179 or email to info@clincialtrialsinc.com. Someone will ask you a few simple questions to see if you might qualify for any studies we are conducting. Medical records may be required.

How much do you pay?

We do NOT pay for your participation. There are reimbursement/compensation programs for your time and travel. Amounts vary for each study depending on study requirments. Please call for this information.