What Is Clinical Research?
Are there risks to participating in clinical trials?
Are there benefits to participating in clinical trials?
What are the responsibilities of a participant?
What are the costs associated with participation?
How does a person become involved in a clinical trial?
What protection does a patient have as a participant in a clinical trial?
Is a patient’s study participation and medical information kept confidential?
What questions should you ask before deciding to participate in a clinical trial?
A clinical trial is a research study sponsored by a pharmaceutical company to evaluate the safety and effectiveness of an experimental medical device, treatment or medication. After showing benefit in the laboratory, new treatments must be tested among small groups of people to determine the proper dose and to test the safety. After a dose has been determined, the dose is tested on large groups of volunteers to evaluate the safety and effectiveness of the treatment for a specific condition, such as eczema, psoriasis or acne.
The Food and Drug Administration (FDA) require pharmaceutical companies to conduct clinical trials before new treatments can be made available to the public for prescription or over the counter use. Clinical trials are carefully monitored under the FDA’s strict regulations.
Clinical trials are important to ensure that people receive safe and effective treatments. The trials provide a way to develop new treatments that are as effective, more effective, or safer than treatments already on the market. The trials also make it possible to develop new treatments for conditions that currently have no treatments available.
Are there risks to participating in clinical trials?
Although every effort is made to minimize potential risks, there may be side effects and other health risks not yet known. Side effects differ from one person to another, and there is no way to predict how the treatment will affect any individual. One potential risk to participants is the possibility of receiving an inactive treatment (placebo) or the study treatment may not be effective. In those cases the participant’s condition may worsen. Foreseeable risks will be listed in the Informed Consent Form.
Are there benefits to participating in clinical trials?
Volunteers who participate in clinical trials help to further advance medical science, which may help others in the future. There are no guarantees that participants will directly benefit from the treatment they receive, some participants may find that the study medication relieves their condition more effectively and with fewer side effects than currently available treatments. Other benefits include free study medication and study related office visits, as well as financial compensation as reimbursement for time and travel.
A placebo is an inactive substance that contains no medication. Clinical trials may use a placebo to evaluate the effectiveness of the active ingredient in the study medication.
Informed consent is the process by which a potential study participant is provided with information about the study and treatment. It is used to assist the participant in deciding whether or not to participate in the trial. The informed consent includes information on why the study is being conducted, what will be done during the study, how much time is involved, potential risks and benefits, and a listing of who to contact in an emergency.
Participation in a clinical trial is completely voluntary. All questions about the study should be answered completely before the informed consent form is signed. Patients have the right to refuse participation or to withdraw from the trial at any time during the study without the risk of a penalty.
The wishes and best interest of the patient are considered at all times. Participants will be notified if new information becomes available that may affect the participant’s willingness to continue in the trial. The study doctor may also withdraw a patient at any time, with or without the participant’s consent, during a study if the patient does not follow directions, the study is discontinued, or it is not in the patient’s best interest to continue in the study.
What are the responsibilities of a participant?
The participant must give a full and accurate medical history regarding past and current medical conditions, illnesses, and all medications used currently and in the recent past. The participant must follow all directions regarding the use of the study medication, and return all medication upon the completion of the study. They must attend all scheduled appointments to ensure that the study doctor monitors the progress of the participant.
What are the costs associated with participation?
There is no cost to participate in a clinical trial. All study medication and study related office visits, procedures, and laboratory tests are provided at no cost to the participant. Participants may be responsible for costs such as parking or meals. Financial compensation at the completion of the trial is provided to cover such costs.
How does a person become involved in a clinical trial?
There are many ways to find out about clinical trials, including advertising, listings on the internet, mailings, radio and television commercials, word of mouth, and physician referrals. Patients looking for a clinical trial for a specified condition should discuss the available options with their physician.
Once a patient contacts a research site, the caller with usually have a brief telephone interview to determine if he or she would likely be a good candidate for the study. A screening visit may then be scheduled for the candidate to discuss the trial in more detail and to further screen the candidate for qualification, possibly resulting in study enrollment.
To find out what studies Virginia Clinical Research, Inc. is currently enrolling patients in, please refer to Ongoing Studies.
What protection does a patient have as a participant in a clinical trial?
Clinical trials are governed by clearly defined ethical and legal codes. In 1981, regulations of the Food and Drug Administration made it a requirement that all federally regulated clinical trials be reviewed and approved by an Institutional Review Board (IRB) before and during the course of the trial. An IRB is a committee of volunteers including experts and lay people such as doctors, scientists, clergy, and other community members. Their primary goals are to protect the patient, to evaluate whether the potential benefits outweigh the potential risks, to ensure that patients are fully informed about the study before and that they are not being coerced to participate.
Study protocols and the progress of the clinical
trials are periodically reviewed by the IRB as well as by the study sponsor.
The FDA and other governmental agencies oversee the IRBs.
Ongoing changes to clinical trial regulations and the review process help to ensure that the rights and welfare of study participants are protected more thoroughly than in past years.
Patients may call the IRB with questions about their rights as a research participant. The name and telephone number of the IRB reviewing the clinical trial is included in the Informed Consent Form.
Is a patient’s study participation and medical information kept
confidential?
Patient confidentiality is maintained as much as possible during and after a clinical trial. The patient’s name may not be disclosed without the permission of the participant unless required by law. The study doctor, the sponsor, FDA, and the IRB have access to the patient’s medical records. To ensure confidentiality, a patient is identified throughout the study by a number assigned to them along with their initials.
What questions should you ask before deciding to participate in a clinical trial?
Home - Meet the Staff - Ongoing Studies - What is Clinical Research? - Employment Opportunities - About Us - Contact Us