In medicine, clinical trials are how medical treatments — medications, devices, and treatment strategies — are investigated for safety and effectiveness in humans.

Clinical trials are scientific research designed to produce the highest-quality data possible, so they are conducted in adherence to the strictest scientific standards. These standards are in place for two reasons:

• Patient Safety
• Reliability of the Data

Clinical trials are one of the last steps in the long and careful process of studying whether medical treatments are appropriate, safe, and effective. In most cases, the process of investigating a new treatment begins in a laboratory, where new ideas are first developed and tested.

Approaches that work well in the lab may not actually work well outside of the lab. So promising ideas progress from the lab to the next step, which involves showing how the new approach affects a living body (non-human). Similarly, a treatment — such as a new anti-cancer drug — that shows promise and appears not to be harmful in animal testing ultimately needs to be tested for safety and efficacy in humans.

This is where clinical trials begin.

Clinical trials are how potential new treatments are tested in people. Because safety is the paramount concern, clinical trials are very carefully conducted and reviewed by IRBs (investigational review boards) that exist solely to protect patient safety.

Clinical trials are divided into four phases, each designed to answer a specific research question:

• Phase I – Test a New Drug or Treatment
  • New Treatments are tested in a small number of people for the first time for the purposes of determining its safety, safe dosage range, and to identify its side effects.
    Learn More About Phase 1


• Phase II –
  • Test a new treatment in a larger group of people to determine its effectiveness & further evaluate its safety


• Phase III -
  • Give a new treatment to even larger groups of people to confirm its effectiveness, monitor its side effects and compare it to existing treatment methods. Also used to collect information that will eventually allow safe use of the treatment on the open market


• Phase IV -
  • After the treatment has been on the market, gather information about its effects on various populations and the side effects associated with long-term use

Generally speaking, the goal of clinical trials is to advance medical knowledge and help improve patient care by finding out whether a new drug, device, or strategy:

• Improves patient outcomes
• Offers no benefit
• Causes unexpected harm

At the START Center for Cancer Care, we are committed to these objectives and to the overall goal of bringing about a new era in cancer treatment. We’re also committed to pursuing the cure. Today, START is a South Texas leader in advanced cancer care and an international leader in Phase I Clinical Trials.

We conduct the world’s largest Phase I medical oncology program at our research locations in Texas, Spain, and Michigan. People travel from all over the globe to participate in our trials, and we’ve helped bring over 19 modern anti-cancer drugs to market through our research.

For more info about the START Center’s leading role in oncology research and Phase I clinical trials, or to schedule your appointment, call 210-593-5700. Or you can request an appointment using our easy online form.