Clinical trials are an essential part of medical research, providing the data needed to develop treatments and medications for a variety of conditions. From clinical oncology research to vaccine development, these trials can be complex and daunting for sponsors to execute and monitor alone. This is why many sponsors turn to contract research organizations (CROs) to help them with the process. But what types of clinical trials do CROs typically conduct? Before starting a clinical trial, researchers review existing information about the drug or intervention to develop research questions and objectives.
Drug developers, or sponsors, must submit an investigational new drug (IND) application to the FDA before starting clinical research. Once approved, the trial can begin. Clinical trials typically follow a series from initial phase 1 small-scale studies to large-scale, late-stage phase 3 studies. Phase 1 trials are designed to assess the safety of a new drug or intervention.
These trials are usually conducted with a small group of healthy volunteers or people with the condition being studied. The goal is to determine the safe dosage range and identify any side effects associated with the drug or intervention. Phase 2 trials are conducted with a larger group of people who have the condition being studied. The goal is to determine if the drug or intervention is effective in treating the condition and to further assess its safety.
Phase 3 trials involve an even larger group of people who have the condition being studied. The goal is to confirm the effectiveness of the drug or intervention, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or intervention to be used safely. By choosing a CRO committed to operational excellence, customers gain more than clinical trial capabilities: they secure a valuable partner with a shared commitment to the success of their clinical program. As long as clinical trials are carefully designed, reflect what developers know about a product, protect participants, and otherwise comply with federal standards, the FDA allows ample room for maneuver in designing clinical trials. Participating in clinical trials and studies helps researchers get the information they need to develop the right treatments for this age group.
If a new treatment is found to be safe in phase I clinical trials, a phase II clinical trial is conducted to see if it works for certain types of cancer. If researchers consider the intervention to be safe and effective after the first three phases, the FDA approves it for clinical use and continues to monitor its effects. It is estimated that almost three out of four clinical trials are carried out by contract research organizations (CROs), which shows how much sponsors value and trust the work they do. By choosing a CRO committed to operational excellence, customers gain more than clinical trial capabilities: they secure a valuable partner with a shared commitment to the success of their clinical program.
The process protects volunteers participating in clinical trials from unreasonable and significant risks in clinical trials.
