Thursday, August 18, 2011

Is a Clinical Trial for You?

Cancer is and has been one of the most active areas in medical research worldwide for decades. At any time, hundreds of clinical trials are under way on new cancer drugs, treatments or combinations of exisiting treatments.  Many trials may be withing your geographic area. That means you may have access to the very latests treatment for your type and stage of cancer -- even if that drug or treatment option is not on the market yet.

Clinical trials (also called clinical research studies) evaluate new drugs the U.S. Food and Drug Administration (FDA) hasn't yet approved or test new uses for already approved drugs. They also evaluate new combinations of existing drugs and treatments, different dosages of approved drugs, or find the best time to begin using a particular drug or treatment.

How Do Clinical Trials Start?
Every new medication begins in the laboratory. Pharmaceutical company researchers test hundreds of thousands of compounds every year, searching for the few that may prove beneficial. From the time they identify such a compound until it reaches the market (if it does) it could take 10 years or more and cost hundreds of millions of dollars.

Once compounds show promise in laboratory and animal studies, companies apply to the FDA for permission to conduct human clinical trials. These trials occur in four phases designed to determine specific information, such as risks, safety, and effectiveness compared with a standard drug or therapy.

Each phase is strictly regulated and evaluated, and the safety of the participating is always the top priority. If there are any safety concerns, officials will halt the trial. Only after a cancer drug has been shown to be safe and effective -- or more effective, or otherwise better than existing ones -- does the FDA approve it for sale in the United States of America.

Why Participate in Clinical Trials?
When you volunteer for a cancer clinical trial, you are guaranteed to receive either the treatment under investigation or the best available standard of care treatment. Unlike clinical studies in other therapeutic areas, patients in cancer clinical trials receive a "sugar pill" placebo ONLY if no standard treatment exists, therefore make sure you know if this is the case before signing up for a cancer clinical trial.

Patients in cancer clinical trials also receive increased monitoring and attention from nurses and  doctors due to being in the trial. Other benefits in a cancer clinical trial include:
  • You may receive access to innovative new treatments that aren't available anywhere else.
  • It offers another option if your cancer has become resistant to treatment or has re-ocurred.
  • You can help further medical research not only for yourself but for other cancer patients as well.
Are Clinical Trials Safe?
All cancer or medical treatments carry risks, even those that have been used by thousands of patients. Not all treatments prove to be better that the standard of care and may produce additional side effects. Yet all clinical trials must meet rigourous guidelines designed to protect you. You will be monitored very closely during the trial  for any potential side effects or problems. Also, healthcare professionals involved in the study will explain any known or anticipated risks to you before you commit to the trial. This is part of the informed consent process.

What is Informed Consent?
Informed consent is your right as a clinical trial participant. A document will outline the purpose of the study (clinical trial), the exact treatments you will receive, all possible side effects (known or anticipated) and your right to withdraw at any point. Signing the informed consent form acknowledges that the trial was explained to you and you understand it. However, you can withdraw from a clinical trial at any time , even after signing the form.

Phases of a Clinical Trial:

A clinical trial typically includes four phases of testing and information collection as follows:

Phase 1  This stage tests the safety of a potential new drug or therapy on a small number of humans to find the best dosage and potential side effects.

Phase 2   Using the dose and schedules determined in Phase 1, this stage discovers more about how effective the treatment is for patients.

Phase 3   This stage compares the new drug or therapy with a standard therapy in a randomised study involving hundreds of participants.

Phase 4   After the drug is approved for marketing this stage lets pharmaceutical companies gather more information as the drug is used in thousands of patients and conduct additional trials investigating other uses for it.  

How Do I Participate in a Clinical Trial?
If you are interested in participating in a clinical trial, talk to your doctor. Cancer doctors are usually aware of ongoing studies. Very often, they are helping to conduct a trial by having some of their patients participate. Clinical trials are conducted in hospitals, universities, cancer centers, clinics, and even doctor's offices.

Get Help With Decision Making:

Ask questions before signing up for a clinical trial.   Choosing to be in a clinical trial is an important personal decision. Discuss the following questions with your healthcare team to make an informed choice and decision about which clinical trial you participate in.
  • What is the purpose of this trial?
  • How ill I benefit?
  • What are the potential risks?
  • What will be required of me and my family?
  • What kinds of test and procedures are involved?
  • Do I have to change doctors to be in the trial, or can I stay with my own doctor?
  • How will I learn the final result of the study?
  • Will I be paid or do I have to pay to participate in the study?
  • What follow-up is involved once my treatment in the trial ends?
  • What treatment will I receive if I do not participate in this clinical trial?
Please remember your healthcare team and family doctor are the best sources of information for your individual care. If you have any questions about this article or you are interested in clinical trials talk to your doctor.

Stevie JoEllie's Cancer Care Fund is working to develop and launch an access to care grant program for thyroid cancer patients and survivors nationwide. Please consider supporting our unique initiative that includes a set aside fund for healthcare access to assist thyroid cancer survivors with medical costs associated with follow up treatment, annual exams,  diagnostics and medications. 

SJCCFThyNet is a project of United Charitable Programs Inc., a 501(c) 3 Public Charity and as such all donations are tax deductible as allowed by law. 

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