Clinical research studies, or trials, serve to test the safety, effectiveness and possible side effects of an investigational medicine or device on a group of volunteers. Clinical research studies are an important step in making new medications available for future use. By volunteering for a clinical research study with KRG, you are an important link in a long chain of research and testing.
At KRG, we strive to provide a comfortable, courteous and professional environment for our research volunteers. If you would like to volunteer, please check our current studies page to see if you may qualify for one of these important studies.
What to Expect in a Clinical Trial
Every clinical trial is a bit different so there is no typical trial. Still, you may want to see an example of what a clinical trial really involves before joining. Here, we've created a fictional clinical trial designed to last one year. The description below resembles the "procedures section" you would find in the trial's informed consent document. Keep in mind that clinical trials can vary from very few to a very large number of participants and can last from one visit to a decade or more. Therefore, this example may not resemble any clinical trials occurring now.
About Clinical Trials:
Clinical trials are research studies that test new interventions in people. An intervention can be a drug, a device such as a pacemaker, a diagnostic tool, a genetic test, or even a new way to prevent disease or offer support for sick people. In some cases, clinical trials test new uses for existing medications. Clinical trials also test new therapeutic options for existing drugs -- for example, a once-a-week dose instead of a daily dose or an inhaled medication instead of an injection. Researchers use clinical trials to find out whether an intervention is safe and whether it is effective. Keep two things in mind:
Clinical trials are experiments -- researchers don't know whether the drug or device works or doesn't work beforehand
Clinical Trials are not right for everyone.
Clinical trials get started when researchers develop new ideas for medical research. These researchers may work for private companies (such as drug manufacturers), medical centers (including hospitals and medical schools), or government agencies. Before they begin any research on people, researchers must test their ideas in laboratory experiments and animal studies (sometimes called preclinical studies). Ideas that succeed in these early tests go on to clinical trials.
Clinical trials are required by federal law. The Food and Drug Administration (FDA) requires companies to show that new medical products are both safe and effective before approval. Clinical trials are the best way to prove that new medications, practices, or devices are safe and effective.
2. What Are Some Different Types of Clinical Trials?
- Treatment trials are the most common type of clinical trials. They test new or alternative potential treatments for specific diseases or medical conditions.
- Prevention trials test new ways to prevent specific diseases, evaluating new medications or lifestyle changes.
- Screening trials test new ways to detect specific diseases, especially diseases that may have an early stage before they produce symptoms.
- Diagnostic trials study tests or procedures that could be used to identify disease more accurately and at an earlier stage.
- Genetics studies are sometimes part of another clinical trial. The genetics component of the trial may focus on how genetic makeup can affect detection, diagnosis, or response to treatment. Other types of medical research studies involve people but do not involve new procedures. They range from experiments assessing the quality of new questionnaires to tests of organ functions.
3. How Do I Find a Clinical Trial?
People interested in clinical trials can identify trials that are open to enrollment in several ways.
Some of the most common ways are:
1) Referral from your doctor or other health professional.
2) Participate in clinical trials sponsored by government agencies:
A) The National Cancer Institute Clinical Trials
B) The National Eye Institute
C) The AIDS Clinical Trials Information Service
D) Other trials sponsored by the National Institutes of Health
E) Clinical trials at the Clinical Center of the National Institutes of Health in Maryland This clinical center conducts a variety of clinical trials on healthy individuals and those with medical conditions.
3) Clinical trial listing services. These organizations provide general information about clinical trials that seek participants for enrollment, especially trials sponsored by industry. Listing services often group available trials into specific medical specialties, such as heart disease or cancer. These include CenterWatch, ClinicalTrials.gov, the Clinical Research Investigators Registry, and ACT! - About Clinical Trials.
4) Clinical trial matching services. These organizations provide more specific details about clinical trials that may be appropriate for you to consider, based on information that you provide them. These services match your personal characteristics with the inclusion and exclusion criteria of clinical trials in an area of interest that you choose. Obviously, these services can only match you to clinical trials listed in their files, so you should consider other resources to supplement matching services. These include Acurian, CancerAdvisors, Emerging Med, and Veritas Medicine.
4. Who Decides If I Am Eligible for a Clinical Trial?
Some clinical trials enroll healthy people, while others enroll only patients with certain problems or diseases. Researchers establish these guidelines to ensure that their study will provide useful, reliable results. Researchers do not use study guidelines to reject people personally. The guidelines must be determined before the trial starts. If you meet the study's guidelines, you are eligible to join.
Researchers must make two types of decisions about whom they study in a clinical trial, called inclusion criteria and exclusion criteria. · Inclusion criteria are those characteristics that everyone must have to join the trial. For example, in a study of a medication for people with diabetes, all study participants might need to have diabetes. · Exclusion criteria are those characteristics that people cannot have if they want to join the study. For instance, in a study of a medication to prevent heart attacks, people who have already had a heart attack might be excluded.
5. Who Decides What Intervention I Will Get During a Clinical Trial?
If you want to join a clinical trial to get a specific medication or procedure, then clinical trials may not be right for you.
Many clinical trials test a new drug against a placebo, which looks just like the drug but doesn't contain active ingredients (like a sugar pill). Other clinical trials test two different drugs to see which is more effective. If it is a randomized trial, participants are randomly assigned by computer to the drug or the placebo. Because researchers have no say in the decision, the process is fair for everyone. However, randomization also means that researchers cannot guarantee what you will get if you enter the trial.
Some trials compare different drugs or different doses to learn which is most effective. Typically, participants are randomly assigned to one drug and do not know which medication they are taking.
Other clinical trials offer the same intervention to all participants. Usually these are Phase I trials that test the safety of a new medication.
6. How Will My Doctor Be Involved If I Join a Clinical Trial?
During the trial, researchers may provide care for your condition, or they may leave that up to your own doctor or doctors. Even if study researchers do provide some care, they usually only take care of the medical condition they are studying. You still need to see your own doctors for general medical care. Personal doctors are also an essential source of advice about clinical trials. You should consult your doctor before joining a clinical trial, and again during the trial if you have questions or concerns. You have a difficult decision to make if your personal doctor is also the clinical trial researcher. As the researcher, your doctor could have personal or even financial reasons to ask you to join. In that situation, you should consider whether you can judge the merits and risks of the study fairly and look for other sources of impartial information. You might consult with other doctors, or ask friends and family to help you review information. All clinical trials must be affiliated with an office devoted to the protection of human subjects, which may be another source of guidance.
7. How Do Researchers Protect My Confidential Information?
Clinical trials may differ in how they protect your confidentiality, but some basic principles always apply:
- You will never be identified by name in any research paper published about the clinical trial.
- The FDA can inspect the medical records of participants in clinical trials,but federal laws protect that information from being used elsewhere.
- Some institutions have a Certificate of Confidentiality. This protects researchers from having to disclose information they gather during a clinical trial.
Unless otherwise specified, researchers never give information that can identify you to anyone not involved in the clinical trial. During the informed consent process, researchers should tell you how your research materials will be handled. Typically, researchers use locked offices and cabinets and identify material by your assigned study number, rather than your name.
8. How Does a Clinical Trial Work?
The FDA groups clinical trials into four phases. Each of these different phases addresses a separate research question.
- Phase I: First, researchers test a new drug or device in about 20-100 healthy volunteers to determine whether it is safe and what side effects it may have. Researchers also study how long the drug stays in the body, which helps them decide what doses to test further. Phase I studies primarily address the question of safety.
- Phase II: Researchers test the new drug or device in about 100-300 people to determine whether or not it works and to learn more about possible side effects. So Phase II studies address safety and effectiveness.
- Phase III: Researchers compare the new intervention to current standard therapy to learn whether it offers any advantage. In a Phase III study, several hundred to several thousand people receive the new drug or device. The FDA will only approve drugs that complete Phase III testing.
- Phase IV: To monitor long-term side effects, effectiveness, and other potential uses, researchers continue to study new interventions after they are approved and in regular use.
In many clinical trials, the main researcher (or principal investigator) is a doctor, but nurses, psychologists, social workers, dietitians, and therapists have all conducted clinical trials. All clinical trials testing new drugs include one or more licensed physicians, who order the medications and laboratory tests. Nurses monitor vital signs and make other clinical measurements during studies, and technicians perform laboratory tests and X-rays. Often, research coordinators schedule appointments, provide reminders, and perform other valuable administrative functions. Depending on the type of trial, clinical trials may use nutritionists, physical therapists, or other similar professionals to help with certain parts of the study. To determine the final results, statisticians and other experts analyze the information collected during the trial.
Clinical trials can also occur in many settings. Many hospitals, especially those linked to medical schools, host clinical trials. Some clinical trials take place in doctors' offices, while others occur community clinics or health centers. Clinics that specialize in running trials are now open in many states.
9. How Are Clinical Trials Financed?
In the United States, the National Institutes of Health (a branch of the federal government) and drug manufacturers sponsor most clinical trials of new drugs. These sponsors pay teams of investigators to conduct and oversee the trials. Researchers and sponsors negotiate many kinds of financial arrangements, and researchers can earn considerable income from trials. In many cases, sponsors also pay individual doctors, researchers, or specialized companies to recruit and enroll people interested in participating in a clinical trial.
Most of the time, patients do not pay any money to participate in a clinical trial. In fact, you may receive a small payment for joining the clinical trial. The payment usually depends on how much the trial will disrupt your regular activities and how much risk it involves. You may also receive parking vouchers, meal coupons, and similar reimbursements for your time and effort. However, some clinical trials do involve ancillary care that the patient must pay for. Your health insurance or managed care provider may or may not cover the cost. In many cases, it helps to have someone from the research team talk about coverage with representatives of your health plan.
10. What Happens If I Want to Leave a Clinical Trial?
An important safeguard in a clinical trial is your freedom to leave. You can leave a clinical trial at any time for any reason. The informed consent document that you sign does not force you to remain in a trial. Clinical trials may offer you suggestions about how to leave the trial, particularly if the trial medication needs to be withdrawn gradually, but you have the final decision. If you do leave a clinical trial, it may be helpful to let the researchers know why you are leaving, although it is not required. This information may help researchers improve the clinical trial experience for other participants and may make the results of the trial more reliable.
11. Can I Be Forced to Leave a Clinical Trial?
Without trial participants, clinical trials fail and medical science suffers. For these reasons, researchers generally make great efforts to help you complete clinical trials. Before the clinical trial, you should clarify exactly what is expected from you. Normally, only participants who violate the clinical trial intentionally would be removed from the trial.
Occasionally, researchers must end your participation in a clinical trial for other reasons. These include:
- Changes in your health that disqualify you, based on the study's inclusion and exclusion criteria
- Changes in your health that make the study more risky or dangerous
- A sponsor ends the clinical trial
- Researchers learn new medical information that makes the study unnecessary or possibly dangerous.
12. How Do I Get the Results of a Clinical Trial If I Choose to Join?
Researchers may choose not to give you results while a clinical trial is ongoing. One exception is when a researcher discovers a potentially important medical finding that requires immediate attention. If that happens, the researcher will notify you and -- if you agree -- your physician.
At the end of the clinical trial, you may ask for your results. Researchers will not send the results to anyone else without your permission, including your physician. You also will not be able to get results from other participants. Because analyzing the clinical trial can take several months or years and may include confidential information, you may not receive the overall results of the clinical trial. If you are interested, you may ask the study researcher whether such information will be available to you.
Your Rights & Informed Consent:
Since World War II, government organizations worldwide have declared that you have specific rights if you agree to participate in a clinical trial. No one can take these from you.
- You have the right to join a research study only if you wish to do so. You should never be pressured or coerced to join a study.
- You have the right to leave a research study whenever you want. You should never be pressured or coerced to stay in a study. You cannot lose access to your regular medical care if you leave a study.
- You have the right to full and complete information about what the study means for you personally. This is the process of informed consent.
- You have the right to ask questions about the study, both before it begins and as it continues.
- You have the right to know about alternative options. When you evaluate a clinical trial of a new medication, you should receive information about other treatments (if any) that exist.
- You have a right to join a clinical trial if you meet the eligibility criteria. You should not be excluded on the basis of age, sex, race, or any other characteristic unless this is explicitly stated in the approved protocol.
Informed Consent -- What It's All About
Informed consent is a crucial aspect of clinical trials. Informed consent is the process of giving you all of the information that you need to make an informed decision about a research experiment.
Informed consent has several parts:
- Researchers clearly and accurately describe what the clinical trial involves.
- Researchers provide all of the information in writing in the informed consent document.
- You review the information and ask as many questions as needed.
- You decide whether to join and sign the informed consent document.
- You receive a copy of the signed informed consent document.
The informed consent document is a written description of what will happen in the study. In some clinical trials, the informed consent document may be several pages, but you should read it carefully. Only when you understand it fully should you join a clinical trial. If parts are complicated or unclear, ask for clarification until you are satisfied. Keep a copy of the document because you may have questions later.
The Informed Consent Document
Informed consent documents generally include the following sections:
- Introduction: A general reminder about your rights as a study participant. Purpose of the Study -- A brief statement about why researchers plan to do the clinical trial. It should mention whether you will take any experimental medications not yet approved by the federal government.
- Subject Selection -- A description of how many people will enroll in the study and what the selection criteria are.
- Procedure -- An explanation of all of the tests and procedures that you will undergo, such as hospitalizations, clinic visits, questionnaires, and laboratory tests.
- Risks and Discomforts -- A list of all the risks the clinical trial may contain, such as side effects or complications from medications or medical procedures. Researchers should also explain how common these risks are.
- Benefits -- A description of the direct benefits you can expect. In clinical trials that test new medications, benefit from those medications is not included, since researchers do not yet know what the benefits will be.
- Alternatives -- An explanation of your options if you do not participate. These include using standard therapies for specific medical conditions.
- Participation and Withdrawal -- A reminder about your right to leave the clinical trial at any time, and an explanation of reasons that a researcher may remove you from a trial.
- Cost or Payment -- A list of expenses that you can expect and any compensation you will receive.
- Injuries -- A statement about who will pay for your medical care to treat research-related injuries. Federal guidelines require that this section be included in all informed consent documents, even for clinical trials that pose minor risk.
- Confidentiality -- A description of how researchers will ensure that information from the clinical trial remains private and confidential.
Clinical trials differ in what they involve, so some informed consent documents may not include all of these sections.