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If you are thinking about volunteering to participate in a clinical trial being conducted by Skyview, the information that follows will answer general questions about how clinical trials are conducted, participation, factors to consider before agreeing to participate, benefits and risks, patient confidentiality, compensation, and the Skyview Clinical Research Division leaders.
Frequently Asked Questions (download printable version here)
What is a clinical trial?
Every year, thousands of people help gather critical scientific data by participating in research trials involving new and currently marketed medications and medical equipment.
A clinical trial is a research study in which volunteers receive investigational treatments under the supervision of a physician and other research professionals. These treatments are developed by pharmaceutical and biotechnology companies who select qualified physicians, also known as investigators, to conduct clinical trials to determine the benefits of investigational drugs.
Clinical trials are conducted to collect data regarding the safety and efficacy of new drug and device development. Drug and device testing begins with extensive laboratory research which can involve years of testing in animals and human cells. If the initial laboratory research is successful, organizations send their data to the Food and Drug Administration (FDA) for approval to continue research and testing in humans.
Drugs and devices must advance through several stages of approval in the human clinical trials process before they can be sold in the consumer market. Clinical trials are usually conducted in three phases (I, II, III). Only a small number of people participate in phase I trials; Phase II and III clinical trials typically involve a larger number of volunteers. Each phase is considered a separate trial and, after completion of a phase, investigators are required to submit their data for approval from the FDA before beginning the next phase of the new trial.
There are many different kinds of clinical trials, including those to study:
- Preventative measures
- New treatments or new ways to use existing treatments
- New screening and diagnostic techniques
- Options for improving the quality of life for people who have serious medical conditions
Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each volunteer participating in the study must agree to the rules set out by the protocol.
How does a clinical trial work?
In a clinical trial, a volunteer is usually assigned to a specific study group. For example, volunteers in one study group may receive an investigational treatment or study drug, while other volunteers may receive a placebo, or a treatment that has already been approved for distribution in the consumer market.
A placebo is an inactive, fake, or "dummy" medication or treatment designed to resemble a drug or treatment, and is administered in the same way. The volunteer, physician, and research staff may not know which trial volunteers receive a placebo, and which receive the active treatment. Not knowing which participants are receiving the active treatment allows the physician and research staff to objectively observe the volunteers during the study. Regardless of which treatment volunteers receive, the level of medical attention and care that each receives throughout the length of the trial is the same.
Who can participate in a clinical trial?
All clinical trials have participation guidelines. Volunteers must meet these guidelines in order to qualify for a clinical trial. Various criteria including age, gender, the type and stage of a disease, previous treatment history, and other medical conditions determine whether or not a volunteer can participate in a clinical trial.
Some research studies seek participants with specific illnesses or conditions to be studied in a clinical trial, while others require healthy participants. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants, promote participants' safety, and ensure that researchers glean good data from the study.
What can volunteers expect if they choose to participate in a clinical trial?
In some studies, participants who have been approved to participate in a study receive physical examinations and their medical histories are reviewed by the physician overseeing the trial, or a trial staff member. What is expected of volunteers varies from study to study; however, a detailed description of the study requirements will be outlined during the consent process, as will specific clinical trial information. Volunteers can expect that their health will be continually monitored during and after a clinical trial.
What questions should volunteers ask before choosing to participate?
Patients who are thinking about participating in a clinical trial should discuss the trial with their physicians and medical caregivers.
Items to consider, and questions to ask, include:
- How long the trial will last.
- Where the trial is being conducted.
- What is the main purpose of the trial?
- How will patient safety be monitored?
- What are the possible risks and benefits of participation?
- Who is sponsoring the trial?
- Do I have to pay for any part of the trial?
- What happens if I am harmed by the trial?
- Can I opt to remain on this treatment, even after termination of the trial?
Are clinical trials safe?
The federal government has clinical research regulations and guidelines intended to protect participants from unreasonable risks and outcomes. While every effort is made to control the risks to clinical trial participants, some risks may be unavoidable because of the uncertainty inherent in medical research studies involving new medical treatments.
The government requires that researchers provide prospective participants with complete and accurate information about the trial process. Approved volunteers are required to sign an "informed consent" document before joining the study. Execution of this document indicates that the participant understands that the trial is a research study, and that the participant can leave the study at any time. During the consent process, prospective participants are informed about risks that might be associated with the study, and whether there are potential, but as yet unknown risks that may be associated with the product being studied. Armed with this information, potential volunteers are able to make an informed decision about the level of risk they are willing to accept before they enter the trial.
What are the benefits and risks of participating in a clinical trial?
Volunteers in a clinical trial participate in the development of medical therapies that may offer better treatments and even cures for life-threatening and chronic diseases; however, there are risks involved in any clinical trial.
Possible benefits for volunteers include:
- The opportunity to play an active role in their health care.
- Access to research treatments before they are widely available.
- Medical care throughout the trial.
- A contribution to medical research.
Possible risks for volunteers include:
- The potential for unpleasant, serious, or even life-threatening side effects to experimental treatment.
- experimental treatment may not be effective for the volunteer.
- The time and attention that the trial will require.
Does a volunteer’s personal information remain confidential and private?
Access to personal information is usually available to the investigator and research team conducting the clinical trial. An Institutional Review Board (IRB) acts as a middleman between the investigator who is conducting the trial and the sponsor of the trial. The IRB is charged with protecting the rights and welfare of clinical trial volunteers. In some circumstances, the IRB and the sponsor coordinating the trial will also have access to personal information.
Volunteer confidentiality is discussed in detail during the consent process and on the form that participating volunteers are asked to review and sign. As a clinical trial progresses, researchers report the results at scientific meetings, to medical journals, and to various government agencies; however, the names of participants are not released to these institutions and publications.
Do volunteers receive compensation for participating in a clinical trial?
Subjects are sometimes compensated for participating in a clinical trial, especially in the early phases of drug or medical device development. Payment information, including the amount and schedule of payment(s), as well as any possible costs to volunteers who participate in a study, are reviewed participants during the informed consent process.
What happens when a clinical trial is finished?
After a clinical trial is complete, data is collected and evaluated in order to determine a drug's effectiveness, safety, and side effects. These results help researchers decide whether to discontinue testing, or to advance to the next phase of a study. After phase III of a study is complete, researchers will often submit medically important findings to medical journals for peer review. The data may then be submitted to the Food and Drug Administration (FDA) for evaluation and final approval to distribute the drug to the consumer market.
Once a drug is approved, pharmaceutical companies may continue to conduct studies that compare the new drug’s safety, effectiveness, and cost to other drugs currently on the market, or assess a drug's long-term effectiveness and its impact on the quality of a person's life.
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