Clinical Trials Defined
Our approach is investigative and it is executed with meticulous accuracy. Valencia Medical & Research Center is able to obtain results that are essential in the release of a new drug to the public and in improving the health of patients.
- What happens when you volunteer for Clinical Trial? You help the medical community progress and find and improve treatments for known illnesses.
- What does your participation mean? You will play a critical role in the development of new drugs that hope to gain accurate results to determine the public distribution of drugs in the future.
Clinical Trial Phases
Phase I
Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.
Length of Study: Several months
Purpose: Safety and dosage
Approximately 70% of drugs move to the next phase
Phase II
Study Participants: Up to several hundred people with the disease/condition.
Length of Study: Several months to 2 years
Purpose: Efficacy and side effects
Approximately 33% of drugs move to the next phase
Phase III
Study Participants: 300 to 3,000 volunteers who have the disease or condition
Length of Study: 1 to 4 years
Purpose: Efficacy and monitoring of adverse reactions
Approximately 25-30% of drugs move to the next phase
Phase IV
Study Participants: Several thousand volunteers who have the disease/condition
Designing Clinical Trials
Researchers design clinical trials to answer specific research questions related to a medical product. These trials follow a specific study plan, called a protocol, that is developed by the researcher or manufacturer. Before a clinical trial begins, researchers review prior information about the drug to develop research questions and objectives. Then, they decide:
- Who qualifies to participate (selection criteria)
- How many people will be part of the study
- How long the study will last
- Whether there will be a control group and other ways to limit research bias
- How the drug will be given to patients and at what dosage
- What assessments will be conducted, when, and what data will be collected
- How the data will be reviewed and analyzed
Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies.