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What Are Clinical Trials

A research study (also referred to as a clinical trial) is a study in which people volunteer to test a new medical treatment. By conducting clinical trials, we learn and understand whether new medications are safe and effective. Also, currently approved medications can also undergo testing for treatment of new indications.

 

Clinical trials are needed to develop new medications for many conditions, including: high blood pressure, arthritis, diabetes, depression, insomnia, Alzheimer’s, etc. Once a new drug is found to be safe and effective, it may be approved by the FDA for doctors to prescribe.
 

Why Participate in
Clinical Trials

Clinical trials play a critical role in medical research by addressing several key objectives:

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  1. Safety and Efficacy: Before any new treatment can be made widely available, it must be rigorously tested to ensure that it is both safe and effective. Clinical trials are the standard for establishing this information, providing the scientific evidence necessary to make informed decisions about healthcare.
     

  2. Regulatory Approval: Clinical trials are fundamental in the process of getting approval from regulatory bodies like the U.S. Food and Drug Administration (FDA). Only after a drug has been proven safe and effective in a clinical trial can it be approved for doctors to prescribe.
     

  3. Innovation in Treatment: Through clinical trials, researchers can explore new ways to treat, prevent, or diagnose diseases. These trials can lead to significant breakthroughs in medicine, offering new hope and potentially life-saving treatments to patients who have few or no other options.
     

  4. Expanding Treatment Options: Clinical trials often assess the effectiveness of a known medication for treating different diseases, thus potentially expanding the treatment options available to patients.
     

Lab Equipment in Use
Doctor and Patient Interaction

Why Are Clinical Trials Safe?

The safety of participants in clinical trials is a paramount concern. Here’s why clinical trials are considered safe:

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  1. Strict Regulations: Clinical trials must adhere to strict ethical and regulatory standards to protect participants. These include rigorous protocols that detail what researchers can and cannot do.
     

  2. Informed Consent: Before participating, individuals must go through an informed consent process where they learn about the study's risks, benefits, and rights. This ensures that participation is completely voluntary and well-informed.
     

  3. Monitoring and Oversight: Clinical trials are closely monitored by ethics committees and regulatory agencies to ensure ongoing safety. Researchers are required to report any adverse events or side effects, and trials can be halted if a treatment proves to be unsafe.
     

  4. Phased Testing: Clinical trials typically progress through several phases, each designed to gather specific information about the new treatment’s safety and effectiveness. Early phases determine safety in small groups, while later phases involve larger populations to confirm effectiveness and monitor side effects.
     

Clinical trials are crucial for the advancement of medical science, contributing to our understanding and management of various health conditions. By participating in a clinical trial, individuals can play a part in discovering new treatments and helping ensure these treatments are safe and effective for everyone.

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