What is a Clinical Trial?
A Clinical Trial (also called clinical study or clinical investigation)
is a planned experiment designed to evaluate the efficacy of a treatment in humans by comparing the outcomes in a group of subjects treated with the test treatment (medications or medical devices) with those observed in a comparable group of subjects receiving a control treatment (no treatment, comparable treatment to the test group, better treatment than the test group). Subjects in both groups are enrolled, treated, and followed over the same period of time.
Clinical Trials also evaluate the effectiveness and safety of medications or medical devices by monitoring their effects on research subjects. Results of the clinical trial are used to determine whether a device, product, or technique should be approved for use in patients or in the general public.
Why do we need volunteers to perform clinical trials? How do I benefit by becoming a volunteer?
Volunteers who engage in clinical trials can play an active role in the way they approach their own health. Study subjects might be the first to benefit from successful new treatments or interventions. Benefits vary with each trial and can be affected by an individual's underlying medical condition (if any) upon entering a trial. Your participation will provide valuable information that could benefit your health as well as the health of others in the future.
Who can join a clinical trial?
All clinical trials have strict guidelines about who can participate. The guidelines 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 variables that include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a subject must qualify for the study. It is important to understand that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate subjects and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
What are the different phases of clinical trials?
Clinical trials are conducted in four separate phases.
Each of the four trial phases (defined below) is designed to answer distinct questions concerning safety, efficacy etc.:
Phase I trials are performed to test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage, and to evaluate side-effects.
Phase II trials involve administering the experimental study drug or treatment to a larger group of people (100-300) todetermine whether the drug or treatment is effective and to further evaluate safety.
Phase III trials are conducted when investigators wish to confirm the effectiveness of the experimental drug or treatment, monitor side effects, compare the intervention to commonly used treatments, and/or collect information that will permit the experimental drug or treatment to be used safely in a large group of people (1,000-3,000).
Phase IV trials are conducted after a drug has already been approved for use in the general population. These trials are used to determine additional information about side-effects, risks, benefits, and optimal use.
How long it will take to complete a clinical trial?
Clinical trials can be completed in as little as two months or over the course of many years. The duration of a clinical trial depends on the disease/condition being treated and the duration required to evaluate efficacy, safety and side effects of a drug or intervention. During the clinical trial, study-subjects will be closely monitored and will be required to return to the research center for several visits. The number of visits varies widely and is listed or approximated in the study protocol.
What is a protocol?
A protocol is a study plan to conduct clinical trials or investigations. The plan is carefully designed to safeguard the health of the subjects as well as answer specific research questions. A protocol describes who may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.
What is a control group?
In many clinical trials, one group of subjects will be administered an experimental drug or treatment, while the control group is administered either a standard treatment for the disease/condition or a placebo.
What is a placebo?
A placebo is an inactive pill, liquid, powder, or intervention that has no treatment value (inactive substance or procedure). In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment's effectiveness. In some studies, the subjects in the control group will receive a placebo instead of an active drug or experimental treatment.
Subjects are given a placebo so that scientists can determine whether there is a different outcome for those who get the study drug or experimental treatment versus those who do not. Usually neither the study subjects nor the doctors or scientists know who receives the study drug or treatment and who receives the placebo until after the trial is complete. This trial method is described as ”double-blinded.”
What is informed consent?
Participation in a research study must be conducted on a volunteer basis. The most important ethical principle in studies that involve human subjects is an individual’s ability to agree or “consent” to participate with a full understanding of what will or could happen to him or her. Research subjects must give their consent before taking part in a study.
The informed consent process ensures that study participants are given an overview of the study and supplied by the research group with all the pertinent information about the study. As part of the informed consent process, the following information is also provided to participants:
1) potential risks and benefits of the research study
2) questions about the research can be asked throughout the course of the study
3) withdrawal from the study is possible at any time
What does "Good Clinical Practice" mean?
Good Clinical Practice is an international ethical standard that researchers agree to uphold. Researchers have a responsibility to maintain honesty and integrity during all phases of the research process. Additionally, researchers must ensure the safety and wellbeing of all research subjects. For example, it is not ethical to involve subjects in a study which poses risks to the subject when a study has little chance of making a scientific contribution. At Bluestone, we have a commitment to protect the rights and dignity of our research patients and study-participants according to federal regulations and Good Clinical Practice.
What are the pros and cons of joining a clinical trial?
Make an informed decision
Anyone who is interested in participating in a research study should learn as much as possible about the clinical trials that interest them. Prospective participants should understand what will happen during the trial as well as the type of health care that they will receive. Sometimes study-participants must pay for treatment or for other costs associated with a study; study participants should be fully informed about these costs. Anyone considering a clinical trial should also be informed that there are both benefits and risks associated with participation.
Participation in well-designed and well-executed clinical trials is one approach for eligible participants/volunteers to:
1) become actively involved in their health care;
2) gain access to potentially beneficial, new research treatments;
3) gain access to expert medical care for the condition being studied, since investigators are often specialists in the disease area being studied; and
4) help others by contributing to medical research.
Participation in a clinical trial can potentially expose a study-participant to known risks as well as to unknown risks.
1) unpleasant, serious, or even life-threatening side effects resulting from the treatment
2) inefficacy of the study treatment
3) additional time commitment as compared to standard treatment regimens
Subjects are sometimes paid for their participation in research, especially in the early phases of investigational drug, biologic or device development. Payment to research subjects for participation in studies is considered an incentive. The amount of compensation is determined by the amount of time you will be required to dedicate to the trial, and to the level of risk or discomfort that might be associated with medical or surgical procedures related directly to the study. Sometimes transportation costs of study-participants (to and from the clinical research center) are paid for by the study sponsor.
Will treatment be discontinued at the end of the trial, even if the participant feels that it is beneficial? Some sponsors continue to provide products while others do not.
Who sponsors clinical trials and where are they conducted?
Who sponsors clinical trials?
Clinical trials are sponsored or funded by different organizations or individuals such as physicians, dentists, medical institutions, foundations, voluntary groups, pharmaceutical companies, and federal agencies such as the National Institutes of Health (NIH).
Where are clinical trials conducted?
Trials can take place in a variety of locations including hospitals, universities, doctors' offices, or community clinics.
Why should I consider study participation at Bluestone Center for Clinical Research?
Bluestone is an organization focused solely on clinical research. Our team is specifically trained to conduct a wide variety of clinical research including clinical trials. We make every effort to help participants feel like they are part of the research team. The result is a personalized, nurturing, patient-centered environment that is more homey than hospital-like.
Participating in Bluestone Center clinical trials offers patients an excellent way to understand clinical research as well as receive special attention for a medical or dental condition. It also provides an opportunity to help others who may be suffering (now or in the future) from a common or rare disease or illness. At Bluestone we always remain focused on the needs and desires of individual patients.