Relationship to Usual Health Care
Typically participants continue to see their usual health care providers while enrolled in a clinical study. While most clinical studies provide participants with medical products or interventions related to the illness or condition being studied, they do not provide extended or complete health care. By having his or her usual health care provider work with the research team, the participant can make sure that the study protocol will not conflict with other medications or treatments being received.

Considerations for Participation
Participating in a clinical study contributes to medical knowledge. The results of these studies can make a difference in the care of future patients by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or interventions.

Clinical trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. Sometimes, the safety and the effectiveness of the experimental approach or use may not be fully known at the time of the trial. Some trials may provide participants with the prospect of receiving direct medical benefits, while others do not.

Most trials involve some risk of harm or injury to the participant, although it may not be greater than the risks related to routine medical care or disease progression. (For trials approved by IRBs, the IRB has decided that the risks of participation have been minimized and are reasonable in relation to anticipated benefits.)

Many trials require participants to undergo additional procedures, tests, and assessments based on the study protocol. These will be described in the informed consent document for a particular trial. A potential participant should also discuss these issues with members of the research team and with his or her usual health care provider.

Questions to Ask
Anyone interested in participating in a clinical study should know as much as possible about the study and feel comfortable asking the research team questions about the study, the related procedures, and any expenses.

The following questions might be helpful during such a discussion. Answers to some of these questions are provided in the informed consent document. Many of these questions are specific to clinical trials, but some also apply to observational studies.
What is being studied?
Why do researchers believe the intervention being tested might be effective? Why might it not be effective? Has it been tested before?
What are the possible interventions that I might receive during the trial?
How will it be determined which interventions I receive (for example, by chance)?
Who will know which intervention I receive during the trial? Will I know? Will members of the research team know?
How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?

What will I have to do?
What tests and procedures are involved?
How often will I have to visit the hospital or clinic?
Will hospitalization be required?
How long will the study last?
Who will pay for my participation?

Will I be reimbursed for other expenses?
What type of long-term follow-up care is part of this trial?
If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?
Will results of the study be provided to me?
Who will oversee my medical care while I am participating in the trial?
What are my options if I am injured during the study?

G Mohan.