The length of a clinical trial varies depending on several factors, such as the type of illness and the type of medicine being researched. For example, if the study is researching a treatment for a chronic condition, participants’ progress on the trial may be tracked over a relatively long period of time. Studies of antibiotics on the other-hand conclude quickly as patients are typically treated on study for a few days only.

After a study phase is complete, the data is collected to determine the drug’s effectiveness, if it is safe and if there are any side effects. Depending on the results, researchers then determine whether to stop testing or move to the next phase of study. After phase III of a study is complete, researchers decide if the results are medically important and may submit them to journals for peer-review. Data then may be submitted to the Food and Drug Administration (FDA) or other governing bodies for approval.
If a drug is approved, pharmaceutical companies may continue to conduct studies that compare the new drug—in terms of its safety, effectiveness, and cost—to other drugs already on the market or assess a drug’s long-term effectiveness and its impact on the quality of a person’s life.

Compensation for clinical trials varies depending on the study. Some clinical trials will compensate you financially for joining the trial. In some studies, researchers will reimburse you for expenses associated with participating in the study. Such expenses may include transportation costs, child care, meals and accommodations.

Some of the benefits in participating in a clinical trial are:

• Take an active role in your own health care.
• Gain access to new treatments that are not available to the public.
• Obtain expert medical care at leading health care facilities during the trial.
• Help others by contributing to medical research.
• If you qualify you may receive compensation for participating.
• If you qualify for one of our research trials you will receive free medication, free doctors exams, free procedures, and reimbursement for time and travel.
• You will also have the satisfaction of knowing that your involvement may help others like yourself.

Some of the risks in participating in a clinical trial are:

• There may be side effects or adverse reactions to medications or treatments.
• The treatment may not be effective for you.
• The protocol may require a lot of your time for trips to the study site, treatments, hospital stays, or complex dosage requirements

Participant safety is our number one priority. The ethical and legal codes that govern medical practice also apply to clinical studies. In addition, most clinical research is federally regulated with built-in safeguards to protect the subjects, such as Good Clinical Practice (GCP) guidelines and informed consent forms. The study follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical study progresses, researchers report the results of the study to various government agencies and ethics boards. Individual subjects’ names will remain confidential and will not be mentioned in these reports.

People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the possible risks of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

• What is the purpose of the study?
• Who is going to be in the study?
• Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
• What kinds of tests and treatments are involved?
• How do the possible risks, side effects, and benefits in the study compare with my current treatment?
• How might this trial affect my daily life?
• How long will the trial last?
• Will hospitalization be required?
• Who will pay for the treatment?
• Will I be reimbursed for other expenses?
• What type of long-term follow up care is part of this study?
• How will I know that the treatment is working? Will results of the trials be provided to me?
• Who will be in charge of my care?

A Principal Investigator (PI) is a person qualified by education, training, and experience to assume responsibility for the proper conduct of a trial. They are usually, but not always, physicians or oral surgeons. The PI bears ethical responsibility for the study and is the leader of the study team. Final responsibility for the quality control of study procedures and the integrity and scientific merit of study findings rests with the PI.

A placebo is a “false pill” or “flour pill” that has no recognized physiological effect. In fact, a placebo is a pharmacologically inactive medication that is given in order to evaluate the possible psychological effect of a study medication. In cases where they are used, participants are advised in advance of the possibility that they will receive a placebo, as well as the reasons why the use of a placebo is necessary for the study.

A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

Yes, you can leave a clinical trial at any time. This is called “withdrawing your consent.” If you plan to stop participating in a study, inform the Study Coordinator or Principal Investigator that you would like to withdraw your consent. You should also inform the Study Coordinator or Principal Investigator of your reason for withdrawing.

Sure, you can refer any friend or family member who is willing to participate in a study.