Clinical Trials //
About Clinical Trials
Clinical trials are research studies that involve people and are designed to test the safety and effectiveness of new medical treatments, procedures or behaviors. Before new treatments, medications or therapies can be widely used, they must undergo these trials to ensure they work and are safe for patients.
A clinical trial typically involves human participants who are assigned to receive one or more types of treatment, which may include a placebo or other control groups, to see how these interventions affect health. These studies are carefully structured to provide reliable evidence that can help guide health care decisions. Through careful planning, testing and analysis, clinical trials help improve medical knowledge, enhance patient care and ensure that new treatments are both safe and effective.
Registering a Clinical Trial
The Clinical Study Registry (CSR) website is designed for investigators and study teams to register clinical trials, streamlining study initiation and building a comprehensive research database to support high-quality research at the University of Pittsburgh.
It serves as the primary point of interaction between study teams and the Clinical Trials Office (CTO) at the University of Pittsburgh. It plays a crucial role in the study initiation process by collecting essential information about all new protocols being proposed at the University. The data gathered through this platform is meticulously reviewed and analyzed by the CTO to determine the suitability and necessity of building a study within the OnCore Clinical Trial Management System (CTMS). This process ensures that the CTO is equipped with the necessary details to support the study team right from the early stages of study startup, providing a smooth and efficient transition into the setup phase.
Clinical Trial Phases
These phases help ensure that new treatments are rigorously tested for safety and efficacy before becoming widely available to patients.
Pre-Clinical
![preclinical](https://cto.pitt.edu/wp-content/uploads/2024/11/preclinical-1.png)
Lab research determines if treatment is useful and safe
Phase I
![phase1](https://cto.pitt.edu/wp-content/uploads/2024/11/phase1-2.png)
6-10 participants to understand effects on humans
Phase II
![phase2](https://cto.pitt.edu/wp-content/uploads/2024/11/phase2-2.png)
2-50 participants to evaluate safety and efficacy
Phase III
![phase3](https://cto.pitt.edu/wp-content/uploads/2024/11/phase3-2.png)
100-200 participants to confirm benefit and safety
Phase IV
![phase4](https://cto.pitt.edu/wp-content/uploads/2024/11/phase4-2.png)
200+ participants to evaluate long-term effects