In the healthcare field, research creates evidenced based care for nurses and physicians; and evidenced based treatment and drugs for patients. After all, Tylenol, which is one of the most commonly used medication to treat pain and fever went through the clinical trial process before being sold in stores. There are different phases of clinical trials used by researchers to get answers and results to questions about a drug's safest dose, side effects, and whether or not the drug can be used to treat more than one type of disease and cancer. Drug research can also reveal if new or presently used medications will treat cancers accommodated by certain genetic features, and target cancer cells within a certain growth phase. The patient's option to enroll in a clinical trial is strictly voluntary and should be preceded by a thorough education about the trial before the study consent is signed which is the responsibility of the research physician and nurse. The patient can leave or discontinue enrollment in the clinical trial at any time.
Benefits of clinical trials can include: future effective treatment for cancer patients; participation in a treatment that the patient may be unable to meet strict criteria for insurance coverage like proton therapy- a very effective and expensive treatment that yields less side effects than radiation therapy. Other benefits include receiving treatment for less cost; and to have a more personalized care experience in which the patient will be closely monitored throughout and after the trial process. Some trials may offer small monetary stipends and other services to increase recruiting; and although the drugs may be supplied free for the study, the patient's insurance may still be used to cover the services connected to the study drug administration and monitoring of results.
Occasionally, a study may call for another tissue biopsy or radiology test in which the written study consent will document whether or not the patient's insurance is responsible for the coverage. There may be blood work needed at different times during the trial for therapeutic monitoring; and if the patient develops side effects during the trial requiring hospitalization, the insurance company will more than likely be used to cover the bill. The patient can also opt to provide blood samples for future research which will be stored in a blood repository until used. Participation and details of the clinical trial is confidential at all times and the patient's identification info and name will be protected in a very secure manner.
The patient is responsible for checking with their insurance company to ensure that they will be covered for clinical trial participation; and for reading the study consent and asking questions for clarification before signing the consent to participate in the trial. The research physician and nurse will be easily accessed throughout the process, hence, the patient should document any side effects and discuss with the study team in a timely manner. It is always important to remember that the patient can disenroll in the trial at anytime.
Phase 0-exploring if and how a drug may work
Phase I- Is the treatment safe?
Phase II-Does the treatment work?
Phase III- Is it better than what's already available?
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