Clinical Trials in OncologyClinical trials in oncology- what does it really mean?Clinical trials are mainly the last step of the process that starts with the laboratory research and animal testing. These are the research studies involving people. The clinical trials in oncology are mainly for the purpose to find answers about new techniques used in diagnosis of cancer, its treatment and manily for the prevention of the cancer and the questions arising from the advanced techniques used for managing the symptoms of cancer. The aim of clinical trials in oncology is to test ways to treat cancer either surgically or through radiation therapy. The trial also tests the treatments involving new drugs. Clinical trials are necessary step for the treatments so that they can gain the status of the standard treatments. It is mandatory for a treatment to undergo 3 to 4 clinical trials phases before it can be adopted as standardized treatment. The aim of the initial trials is to check whether the treatment is safe or not. The late phases are for the determination whether the treatment can work even better. The phases of clinical trials in oncology are- PHASE 1 - it is the first step that involves finding of safe dose and the method that should be followed to give new treatment. The purpose of first phase involves the determination of the affects that new treatment will have on human body. The Number of people participating in this phase ranges from 15 to 30. PHASE 2- less than 100 people are involved in this phase. In this phase, the focus is set on the specific cancer that is being affected by the new treatment. PHASE 3- this phase involves the comparison between the new treatment and the standard treatment which is being used presently for the specific cancer. Large numbers of people are involved in this phase, ranging from 100 to few thousands. PHASE 4- phase 4 is the last phase and it focuses on the safety and long term effectiveness associated with the new treatment. There are strict guidelines that are to be followed during the clinical trials in oncology. Firstly, every clinical trial must have a person in charge, called principal investigator. This position is mostly held by professional doctors. There are rules that must be followed during the clinical trials especially regarding the people who will be eligible to take part in the study as well as in treatment plan. A protocol is prepared by the principal investigator dictating the steps to be followed during the clinical trial. The protocol of the study also consists the information related to the reason of the study, eligibility criteria for the people who can join the study, number of people required for the study, drugs that will be used during the study with the specifications of the dosage. The protocol also indicates the medical tests that will be conducted and the frequency of these tests and the information intended to be gathered from these tests. The protocol for the clinical trials in oncology clearly specifies the conditions for the people who can join the process and those who cannot join. The three common criteria that allow a person to enter in clinical trial process are - the concerned person should be suffering from a certain stage of a specific cancer, he must have undergone certain therapy for the cancer and must belong to a certain age group. These criteria help in maintain the uniformity of the results as the majority of people participating in the process will be alike, so the deviation can be avoided. The criteria for selecting the people also ensure the safety of people so that they are not exposed to an increased risk during the clinical trials in oncology. The person has to pass certain medical tests to ensure the safety. The clinical trials in oncology must include the randomization. The main aim of randomization is to prevent the biasness of results. Sometimes, the results may be biased because of the human factors or other choices. The randomization eliminates this risk. Two groups are formed - the control group which follows the standard treatment for cancer and the investigational group who are assigned the new treatment. The results of these two groups are studied to determine the most effective treatment with the minimum side effects.
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