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Clinical Trials: How They Work and Why They Could Benefit You

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Ben George, MD

Medical Oncologist and Director of the Phase 1 Clinical Trials Program

Froedtert & the Medical College of Wisconsin health network

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What if you could access tomorrow’s medical breakthroughs today? Participating in a clinical trial allows you to do just that.

Clinical trials test new drugs, therapies, surgical procedures and medical devices to find more effective ways to treat diseases, including cancer, heart disease, neurological disease and other conditions.

Sometimes, people are concerned they may receive less treatment if they participate in a clinical trial. However, in no situation will a patient receive less than the standard treatment. In fact, they often end up receiving more care when participating in a clinical trial. That’s because study participants are closely monitored with more physician check-ins and testing. If anything, patients stand to gain by participating in a clinical trial.

Every treatment on the market now was once a clinical trial and through testing, proved itself better than what was then the standard of care. Participating in a clinical trial today means there is the potential that you’ll benefit from the treatment before it’s approved and commercially available. Today’s clinical trials could be tomorrow’s significant medical breakthroughs.

If you decide to participate in a clinical trial, you’ll be part of research that helps move the needle forward for you and others who come after you. Participating in a clinical trial helps researchers learn more about diseases and how people respond to treatment.

There are two types of clinical trials: non-randomized and randomized. In non-randomized trials, all participants receive the treatment being tested. In randomized trials, participants are split with some receiving the treatment being tested and others receiving the current standard of care.

Clinical trials unfold over three phases:

  • Phase 1: This is the earliest phase when researchers are testing to see if a drug or treatment is safe for human use and at what dose. These are typically non-randomized studies with a smaller group of participants for whom standard treatments have not been effective.
  • Phase 2: Once researchers know what dose of a drug or treatment is safe, they are interested in learning more about its effectiveness. For example, if 100 participants are treated with the drug, researchers want to know how many people respond to it. These studies are usually non-randomized but include a larger group of participants.
  • Phase 3: Researchers use this phase to learn if the new drug or treatment is safer and more effective than the existing standard. More participants are brought in during this phase and the studies are often randomized to better compare the new drug or therapy against the existing standard.

Think you might be interested in participating in a clinical trial? Here are a few questions you should ask before signing up:

  • What is the goal of the study?
  • What phase is the trial testing?
  • Is the study randomized?
  • What experimental drug is being tested?
  • How long will the trial last?
  • Will I be hospitalized?
  • What types of tests might I have to take?
  • What are the costs to me?
  • Who will pay if clinical trial funds don’t cover these costs?
  • What side effects, if any, can I expect?

Always ask your doctor if there is a clinical trial that would benefit you. Your physician can answer your questions about the clinical trial you are considering to help you decide if it’s the right choice for you. To learn more about Froedtert & the Medical College of Wisconsin  clinical trials, visit us online or call 414-805-3666.

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