What are Clinical Trials?

Clinical trials are research studies that aim to collect data to usually learn about how safe a new drug or device is. The following are the phases of a human clinical trial.

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Steps:

During phase I, drugs and devices are evaluated for safety. It typically involves 20 to 100 healthy volunteers who are paid to participate in the initial phase of testing, which can take several months. During the study, the drug or device will be studied for its effects on humans. In addition, the impact of increasing dosage levels on side effects is also examined in this phase. 

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Drugs and devices are evaluated in Phase II studies to determine their efficacy. It often takes several months or two years for the second phase of testing to complete. Up to several hundred people may participate in the second phase of testing. There are most often randomized trials in phase II trials, where patients in one group receive the experimental drug and another group receives a standard treatment or placebo. In these studies, the experimental drugs are often blinded to the patients and the researchers.

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Several hundred to several thousand patients are tested blindly and randomized in phase III studies. By testing a large number of patients, the FDA is provided with thorough information about the different outcomes of the drug. After Phase III, the FDA is requested for the approval of the drug.

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Following the approval of a drug or device for sale, Phase IV studies are conducted. After the new drug has been tested, it is checked for how it compares to other medications, how it impacts the patient’s life in the long-term,etc. The findings of phase IV studies would determine whether drug or device is removed from the market or conditions on how it can be used.

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Currently, there are several clinical trials available for people with autism interested in joining to learn more about autism. Certain conditions must be met to be eligible to join. These conditions vary from clinical trial to clinical trial. Many of these clinical trials are currently recruiting but need more people. The below list are some of the clinical trials with a description of each are available as of now. For more information on the study, look at the description section of the website. The list shows two recent notable clinical trials that people with ASD can participate in.

 

1. The following clinical trial is recruiting for 90 participants and is sponsored by the National Taiwan University Hospital, a medical facility located in Taiwan. It aims to learn the effect of esomeprazole, a medication traditionally used to reduce stomach acid, on children with ASD: https://www.centerwatch.com/clinical-trials/listings/212494/autism-spectrum-disorder-efficacy-esomeprazole-children-adolescents/?&query=autism&rnk=3

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2. The following clinical trial is recruiting for 6000 participants and is sponsored by University of Calgary. It aims to use pharmacogenetic testing for children who are starting or changing psychiatric medication. This study is highly applicable to children with ASD: https://www.centerwatch.com/clinical-trials/listings/269106/pharmacogenetic-supported-prescribing-in-kids/?&query=autism&rnk=2

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