Wednesday, April 27, 2016

Risks and Benefits of participating in a clinical trial

What are the risks and benefits  of participating in a clinical trial?

The Risks

There are risks to clinical trials.
  • The clinical trial may require more of your time and attention than would standard of care treatment, including trips to the study site, more hospital stays or complex dosage requirements.
  • There may be unpleasant, serious or even life-threatening side effects to experimental therapy. Side effects can include headache, nausea, hair loss, skin irritation, or other physical problems that the doctor does not expect or desire.
  • The risks and side effects to each experimental therapy are specifically outlined for each trial and can vary. Your doctor and study coordinator will review with you all the risks that are specific to that trial or other physical problems that the doctor does not expect or desire.
  • The experimental therapy may not be effective for the participant.

What about cost? Will my insurance cover it?

While patients cover some of the expenses, government agencies or pharmaceutical companies typically absorb the majority of the costs.

It’s important to get insurance and cost questions answered before deciding to take part in a clinical trial. In the past, insurers were sometimes reluctant to pay for any of the costs of care given in a clinical trial. Their concern was that they’d be paying for treatments that had not been proven to work. Some health insurance plans also defined the care given in a clinical trial as “experimental” or “investigational” and didn’t want to cover the costs of what was really routine care – care that you would have needed even if you were not taking part in a clinical trial.

What is a Clinical Trial and is it right for me?

Do you know clinical trial? what absolutely is a clinical trial? In direct terms, they're examination focuses on that incorporate people. Each trial has a drawn in, unique reason. They can be bolstered by Specialized Programs of Research Excellence, which joins experts and scientists with patients, regulatory associations like the National Cancer Institute (NCI) or by Community Clinical Oncology Programs.

Tuesday, April 26, 2016

Participating in a Clinical Trial

Participating in a Clinical Trial

Enrollment in any clinical trial is completely up to you. Your doctors and nurses will explain the study to you in detail and will give you a form to read and sign indicating your desire to take part. This process is known as giving your informed consent. Even after signing the form and after the clinical trial begins, you are free to leave the study at any time, for any reason. Taking part in the study does not prevent you from getting other medical care you may need.

Clinical Trial Objectives

Researchers conduct studies of new treatments to answer the following questions:
  • Is the treatment likely to be helpful?
  • Does this new type of treatment work?
  • Does it work better than other treatments already available?
  • What side effects does the treatment cause?
  • Do the benefits outweigh the risks, including side effects?
  • In which patients is the treatment most likely to be helpful?

Clinical Trial Phases

There are three phases of clinical trials in which a treatment is studied before the treatment is eligible for approval by the FDA (Food and Drug Administration).

The purpose of a Phase I study is to find the best way to administer a new treatment and to determine how much of it can be given safely. Physicians watch patients carefully for any harmful side effects. The research treatment has been well tested in laboratory and animal studies, but the side effects in human patients are not completely predictable in this phase.