As a cancer patient, you may keep looking for new treatment options and drugs that are more effective. In order to formulate such drugs and treatments, researchers undertake extensive research and keep testing the new formulations until they are able to find the best cure. The new drugs are first researched under controlled lab condition, then they are tested upon animals and lastly on humans. Clinical trials are the last and most important step as the effectiveness and side effects of the drug are tested at this stage.
Phases of Clinical Trials
Clinical trial takes place in phases over a span of several years. Controlled groups are studied at every stage to determine the effectiveness of the drug. Cancer center lists the following phases of a typical cancer clinical trial;
• Phase I: The earliest stage of a trial, phase I recruits less people for study. The trial is usually open to all type of cancer patients. Only 20-30 people are required at this stage. This phase is required to determine the safe dosage, the side effects and how the body reacts and copes with the drug. It also studies what the drug/ treatment does to the tumor.
People are recruited very slowly into this phase. The first few patients are termed as cohort and are administered very low dosage. If there aren’t any severe side-effects, the next group is administered higher doses. With each group the dosage is increased and the groups are continually monitored. This is termed as escalation study.
• Phase II: This stage is usually tests patients with similar type of cancer. This phase aims at finding if the new treatment is effective to test on a larger group, the type of cancer on which the treatment is most effective and the right dosage. Phase II trials are larger than Phase I and therefore recruits more people, nearly a 100 are recruited.
• Phase III: At this stage the new drug/ treatment is compared with the current standard treatment and its effectiveness is measured. Much more patients are involved at this stage as the success rates are very small and to determine them properly large numbers of people are recruited.
• Phase IV: Once the drug shows positive effects and it gains a license, phase IV takes place. This phase is conducted to know the side effects of the drug/ treatment, long term benefits and risks and what effects the drug will have when used in large numbers.
As stated by various doctors at cancer centers, clinical trial is the door to new and better cancer treatment options which will help cure cancer completely without side effects. You too can become a part of such a trial and help make history.
No comments:
Post a Comment