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How Are Clinical Trials Designed?
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How Are Clinical Trials Designed?

Clinical trials have a specific design which allows for a step by step analysis - slow and deliberate - of new drugs, new treatments, new diagnostic tests, as well as quality of life and economic issues. Research teams made up of scientists and physicians from around the world gather together regularly to discuss protocol (trial) design. Now in advanced research, researchers collaborate so as not to duplicate work which wastes time and money. Instead researchers are looking to complement each others work to advance progress more hastily.

Clinical Trials are categorized into four phases as follows:

Phase I - The first time a new drug is introduced to humans. During this phase researchers are looking for the maximum safe dose that can be administered. The emphasis in this phase is monitoring and determining side effects. The new drug is first administered at a very low dose to a small group of people. Doses are increased as they see that patients are safely tolerating the drug until the maximum safe dose is reached.

Phase II - Once the maximum safe dose has been reached the drug is offered to a moderate sized group of patients to measure safety and effectiveness.

Phase III - This is the point in the discovery process when researches learn if the new drug or new treatment option is going to be effective and make a difference. Working with a new treatment option versus a new drug means researchers may be working with a currently approved FDA drug but are now observing this drug working against a different cancer then originally approved for, or with a new combination of drugs, or with a patient at a different stage of their illness. For Phase III research a large number of patients, usually in the thousands, are enrolled. Researchers monitor to confirm effectiveness and safety- meaning side effects. They compare outcomes between new treatments and current treatments always trying the find the best option for patients.

Phase IV - These are trials that monitor drugs and treatments being used after FDA approval. Continuing to determine best use of drug and safest use of drug. Long term effects are determined.

Research has been able to make amazing progress regarding long term survival for many cancer patients. It is also important to know that researchers acknowledge there is more to treatment than medicine and extending life. Researchers involved with cancer also care about 1) Quality of Life and 2) Economics.

You will find that within Clinical Trials there are opportunities to participate in sub-trials. These sub-trials are based on subjective information by patients. Diaries and questionnaires are the instruments used. Researchers want patients to tell them how the medicines and treatments impact their Quality of Life. This information is valuable to how they continue to pursue certain lines of treatment. The third important factor to consider when trying to find cures for cancer is economics. The cost to the patient. The cost to the insurance companies, and the cost to our health care system. Economic analysis studies are done when patients consent to allow their treatment costs to be reviewed.

Clinical Trials are thus designed with three important issues in mind. First and foremost the continued improvement in medicinal and diagnostic treatment. Secondly, the cancer patients quality of life. Patients choice of treatment and their final outcomes are directly related to anticipated quality of life. Thirdly, the economics of medicine matters.

My hope is that as more people are made aware of the availability, the design, and the purpose of clinical trials then more will ask to participate. The more that participate the sooner we will find the best treatments and cures for the wide range of cancers that take so many lives.

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