What is a Side Effect?
A symptom resulting from a treatment that was not the intended purpose of the treatment.
What does Randomization mean?
The process by which study participants are randomly assigned to receive a particular study medication, dosage, or placebo.
What is a Protocol?
A document that states the rationale, objectives, statistical design, and methodology of the clinical trial and the conditions for performance and management.
What is a Placebo?
An inactive substance that may be given to a percentage of the study participants in a clinical trial to assist in evaluating the effects of the active study treatment.
What does Investigational mean?
A medication or treatment that has not been approved for use by the public.
What is an Institutional Review Board (IRB)?
A board, committee, or other group formally designated by an institution to review biomedical research involving human subjects. In the U.S., an IRB reviews the protocol, approves initiation of research, and periodically reviews the conduct of research.
What is the Food and Drug Administration (FDA)?
The American government’s agency responsible for protecting the public’s health by regulating the review, research, and approval of investigational treatments. Informed Consent - The process by which a potential study participant is provided with information about the study and treatment before deciding whether or not to participate in the trial.
What is a Clinical Trial?
The process by which an investigational treatment is tested in human volunteers.
What does Blinded or Masked mean?
The situation in which the study participant, the investigator, or both do not know which study treatment the participant is receiving to ensure unbiased evaluation of the study treatment.
What questions should you ask before deciding to participate in a clinical trial?
- Why is the clinical trial being conducted?
- What type of treatment is being studied?
- What are the known side effects of the study treatment?
- How long is the study?
- How often and when will I be expected to come in for visits?
- How long will each visit last?
- How often, when, and how does the study treatment have to be taken?
- When should I call the doctor?
- Who do I contact in case of an emergency?
- Can I continue my current medications?
- What medications do I need to avoid?
- Should I avoid alcohol, specific foods or other agents?
- What procedures are required during the study?
- What effects should I expect from these procedures?
- What other treatment options are available to me, and what advantages or disadvantages could I expect from them?
- Will I be responsible for the cost of any of the visits, medications, or procedures performed during the trial?
- Will my own physician be notified about my participation in the trial?
- How will my study participation affect my daily life?