The Importance of Seeking Informed Consent for Clinical Trials

Clinical trials

phase 1 clinical trial
Having a loved one who has been given a terminal diagnosis is never welcomed. You and the patient feel desperate for anything that may prolong their life. You are faced with difficult choices. Clinical trials may or may not be the answer for you or a loved one. A large percentage of people feel that taking part in clinical trials is as valuable to our health care system as giving blood. Patients who choose to take part in a clinical trial help to advance treatment options for others.

There are four phases that a drug must go through successfully before it is submitted for approval to go on the market. Before phase 1 clinical trial can even proceed, informed consent is sought from the patient or the person responsible for them. If the researchers plan on using children (anyone younger than 18) for a phase 1 clinical trial, they are legally required to obtain consent from their parent or guardian.

The 9th revision of the American Psychological Association’s Ethical Code has given informed consent its own section (8.02) because it is so important. The patient or parent must understand that clinical drug development is performed to answer the following: What is the safe dose of the drug? Does the treatment really help the disease? How does the body distribute the drug and what are the side effects? As all individuals are unique, they must also understand that the drug may or may not work for them.

Phase 1 Clinical Trial is where researchers test an experimental treatment or drug in a small group of people (20-80) for the first time. This evaluates its safety and identifies any side effects. Phase II is when the drug or treatment is administered to larger groups of people (100-300)to see if it is effective and safe to us. Phase III administers the same treatment or drug to even larger groups (1,000-3,000) to further confirm its effectiveness, to monitor side effects, and compare it with equivalent treatments. The collected information will allow the treatment or drug to be used safely.

Finally, Phase IV is where the team who did the clinical study submits an NDA or New Drug Application for approval to go on the market. A very small percentage of the drugs and treatments that are used in the trials actually go on to be approved by the FDA. It is very important for the advancement of medical treatments that these medical research studies continue.

A patient must be informed of the statistics when consent is being sought. They may decide to live out the rest of their life without receiving a clinical trial. If there are no other options to consider, they may decide it is worth the risk. There have been successful clinical studies that have helped many people. According to a survey in the U.S. about clinical trials, only 4 percent of patients participated in a clinical trial.

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