Clinical Trials

Overview

From diagnosis through survivorship, your treatment plan will be made up of many pieces, each fitting together to accomplish your desired goal. A clinical trial may be one of those pieces. But unless you or someone you know has participated in one, you may not realize the essential role these research studies have in cancer care. This guide is designed to help you learn more about clinical trials so you can be prepared to make the important decisions ahead.

Understanding the Basics of Clinical Trials

Most of the therapies used to treat cancer today were once studied, evaluated and approved through the clinical trials process. Today, thousands of clinical trials around the world continue to search for new and better ways to prevent, diagnose and treat cancer and its symptoms and side effects by evaluating the following:

  • Methods for disease prevention and patient screening
  • Tools and procedures to diagnose disease
  • New or improved treatments such as drugs or drug combinations, medical procedures or devices
  • Lifestyle or behavioral changes that may improve health and/or quality of life

The Four Phases of a Clinical Trial

Traditionally, clinical trials have been designed in four phases, with each phase adding another building block to the study’s foundation of knowledge. The process ensures that only treatments that have been rigorously studied are approved for the public by the U.S. Food and Drug Administration (FDA).

  • Phase I evaluates a new type of treatment, such as a drug, to see if it is safe for use in people. The goal is to determine how the drug should be given, how often and at what dosage to be most effective while causing the fewest side effects.
  • Phase II determines how well the drug works and how safe it is in a greater number of patients.
  • Phase III compares the new drug with the current standard of care to see if it is more effective or has fewer side effects.
  • Phase IV tests a drug that has already been FDA-approved to gather more information about its effect in different populations and learn about long-term side effects.

The time it takes for the FDA to approve new therapies is being shortened considerably based on successes of other trials. Now the FDA considers approvals at any phase of research, including as early as Phase I trials. These advances give patients access to lifesaving treatments sooner.

Considerations for Participating

A clinical trial may offer one or more of the following benefits.

  1. Access to state-of-the-art cancer treatments that are not yet otherwise available.
  2. Your best option if your cancer has become resistant to your current treatment, or if you have a rare type of cancer that has few, if any, approved treatments.
  3. A higher level of care because you will be monitored by the medical team managing your trial as well as by your regular oncologist. Extra medical attention may help identify and address side effects or other problems earlier.
  4. You will become a partner in cancer research, helping improve treatments for other patients and shaping the future of cancer care. The need is great for more clinical trial participants; minority patients are particularly needed.

As with any cancer treatment, those studied in clinical trials present potential risks along with benefits. Ask your doctor about possible side effects and necessary schedule changes to accommodate the tests and appointments required for the trial.

Participating in a clinical trial is a decision only you can make, but you can research your options using trusted resources and get valuable input from your health care team and loved ones.

 

Were the COVID-19 Vaccines Part of a Clinical Trial?

Absolutely. All of the COVID-19 vaccines in use are a result of clinical trials, but the process has not been typical. Developing a vaccine and making it available to the public can take up to 10 or even 15 years, yet the timeline for the COVID-19 vaccines has been significantly shorter. Here’s why.

The COVID-19 outbreak was first reported publicly on December 31, 2019. Because of the work health experts were already doing when the pandemic began, researchers were able to develop the vaccines much faster. By early February, a COVID-19 vaccine candidate was designed and manufactured. By March 16, 2020, this vaccine had entered the first phase of clinical trials. Other vaccines entered clinical trials not long after.

In December 2020, the first COVID-19 vaccine was authorized for use in the United States. This abbreviated timeline for the COVID-19 vaccine clinical trials is due in part to the number of available trial participants, which is much different than for cancer clinical trials. Cancer clinical trials explore a treatment for a specific diagnosis, for example, and each participant in the clinical trial must meet certain qualifications to ensure the data gathered is consistent.

The pool of people who are contracting COVID-19, however, is much bigger — encompassing most of the world’s population. As a result, there are more people available to participate in trials because they do not have to meet such strict criteria.

Clinical trials related to many aspects of the COVID-19 pandemic, such as prevention, treatment and side effect management, will likely be underway for years. As with all trials, they rely on individuals who are committed to helping advance medical research by helping to improve health care options for future patients. If you are interested in participating in any type of clinical trial, talk with your doctor.

 

Next