Clinical trial protocol

Clinical trial protocols are the plans that are followed by all clinical trial professionals. The clinical trial protocols are designed to balance the benefits and risks of all clinical trials to all its participants. The protocols are guidelines to answer specific research questions. They include the following; the goal of the study, the details on tests, treatments, and procedures, the eligibility of participants that will take part in the clinical trials, the length of the trial, the information needed and gathered, and protections against the risks to participants.

A clinical trial is always led by a Principal Investigator (PI), while the rest of the members of the clinical research team regularly monitor the health of the participants to help determine and evaluate the safety and effectiveness of the study.

The clinical trials are often sponsored by clinical trial sponsors who are responsible for the managing, initiating, and/or financing of clinical trials, but they do not conduct or supervise the clinical researches. Clinical trial sponsors include people, companies, government agencies, organizations, or other institutions.

There are different types of clinical trials to choose from which can see you earning $60,412 - $160,876 a year.

  1. Screening Trials. This trial tests new ways of detecting diseases or health conditions.

  2. Prevention of Trials. This trial looks for the best way to prevent diseases from happening or reoccurring.

  3. Diagnostic Trials. This trial studies and compares tests or procedures in the diagnosis of a particular disease or condition.

  4. Behavioral Trials. This trial evaluates and compares ways to promote behavioral changes to improve health

  5. Supportive Care Trials. This trial explores the new ways to improve comfort and quality of life for people with illnesses and conditions.

  6. Treatment of Trials. This trial tests new treatments, a new combination of drugs, new drugs, new surgical procedures, new radiation therapy, and new medical approaches.

There are four phases of clinical trials which serve different purposes and help answer different questions.

Trials Phase 1. This is the testing of drugs or treatments within a small group of people ranging from 20 - 80 to study the drugs or treatments to learn and identify the side effects and safety of the drugs.

Trials Phase 2. This is the testing of drugs or treatments within a large group of people ranging from 100 - 300 to determine the effectiveness of the drugs or treatments and to further study its safety.

Trials Phase 3. This is the testing of new drugs or treatments within a large group of people ranging from 1,000 - 3,000 to monitor its side effects, its effectiveness, it's standards, and also to collect information on how the new drugs or treatments can be used safely.

Trials Phase 4. This is the phase where the new drugs or treatments get approved by the FDA and is made available to the public, to track its safety and to also seek more information about the benefits of the drugs and the treatments.

Take courses from CCRPS and learn more on how to become a clinical trial manager.

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