Frequently Asked Questions

In a clinical trial, participants receive specific treatment or interventions according to the research protocol or research plan. Clinical trials compare a new medical approach to a current standard (if available), to placebo (treatment with no active ingredients). The information obtained helps physicians determine the best treatment for future patients.

A new treatment goes through several phases. Each phase has a different purpose:

• Phase I trials test if a new treatment is safe and looks for the best way to give the treatment.
  Typically, this phase is for healthy volunteers and the primary focus is to gain information on how the drug interacts with the human body.
• Phase II trials test the investigational medication on patients with the diagnosis or medical condition for which the new treatment is being developed. The primary focus is to obtain safety data.
• Phase III trials test if a new treatment provides benefit to a specific population. This phase can also compare new treatment to standard treatment to see if one is superior.
• Phase IV trials are conducted after the investigational medication has been approved by the FDA. This stage is post-market, and the focus is to obtain additional long-term benefits and side effects.

Clinical trials are usually sponsored by pharmaceutical companies, federal agencies, or other health care agencies. Every clinical trial site is led by a local principal investigator (PI), usually a physician. The PI has a research team that includes physicians, nurses and other health care professionals that assist in the care of participants.

Clinical trials have specific criteria that must be met by all participants. This criterion is determined by the sponsor of the study after collaboration with the Food and Drug Administration (FDA).

Deciding to participate in a research trial is a personal decision and you should take time to become informed about the project prior to deciding. All medications must undergo the same stringent approval process which is done to ensure medications are beneficial and safe. Treatments are only available to you today because another individual consented to participate which allowed the collection of information and eventual approval. In addition, participating in research allows patients to receive the most recent treatment alternatives and additional care from participation.

Each research participant must sign an informed consent. The informed consent contains details needed to decide based on the risks, benefits, and alternative treatment. Participants have the right to withdraw from participation at any time. Participants are encouraged to discuss any concerns they have or desire to withdraw with their physician.

Participants will not be charged for any research-specific procedures. However, if the visit is part of routine care, the participants insurance carrier may be billed. Details about all expenses will be explained in the informed consent which must be signed prior to study enrollment. Some trials provide a nominal stipend to cover transportation costs. If this is available, it will be explained in the informed consent.