Clinical Trials

Overview

The myths surrounding clinical trials can make this valuable treatment option seem too scary or far too risky to consider. Some people hesitate simply because they aren’t familiar enough with clinical trials. Others dismiss them outright because of misconceptions based on inaccurate information. As a result, many patients miss an opportunity for access to what may be the most effective treatment for their unique cancer diagnosis.

The truth is, a clinical trial may be the best treatment option when an individual’s cancer has become resistant to the current treatment; when curative therapies are not yet available for that cancer type, subtype or stage; or the cancer is rare and has few, if any, approved treatments. Even with such promise, it is often challenging for researchers to recruit enough adult participants.

Cancer patients who are well-informed about clinical trials have been found to be much more likely to participate, particularly when they are eligible for studies being conducted where they are receiving treatment.

Clinical Trials: Know The Basics

Most cancer treatments used today were once research therapies or procedures that were developed, tested and evaluated through the clinical trials process to gain approval from the U.S. Food and Drug Administration. Clinical trials may be conducted to evaluate new methods for improving different areas of cancer care, including disease prevention, patient screening, diagnostic tools and procedures, genetic risk factors, and lifestyle or behavioral changes that may improve health and/or quality of life. This includes testing drugs, biologics and other non-medication therapies such as radiation therapy and surgery, medical devices, screening approaches and other interventions. Trials may also evaluate patient-reported outcomes, which are important to improving the quality of patient care.

This information focuses on treatment trials. These studies evaluate whether a new treatment, such as a drug or vaccine, drug combination, surgical procedure, type of radiation therapy or a combination of therapies, is more effective or better in some way than the current standard of care.

Clinical trials are carefully planned and structured and highly regulated for the safety of all participants. They often take into consideration the individual’s genetic characteristics and other factors unique to his or her diagnosis. The following are among new types of clinical trials designed for this purpose.

  • Basket trials test the effectiveness of a drug on a single gene mutation/variant simultaneously across tumor types throughout the body. For example, trial participants will all have tumors with the same gene mutation, but the tumors may be in the breast, colon, lung, bladder or other locations.
  • Seamless trials are designed without the traditional distinct phases of a clinical trial. Instead, researchers combine Phases I and II or Phases II and III in a seamless transition that allows greater flexibility to expand the trial and potentially shorten the time for drug development.
  • Umbrella trials are designed with multiple treatment arms within the same study. Participants are grouped into a specific arm based on the type of cancer they have and its molecular profile. You will need to undergo genetic testing before joining one of these trials.

Informed Consent Puts You In Control

Once you express interest in a clinical trial, you will receive comprehensive information in a document known as an Informed Consent form. It details the purpose of the research, including your role in the trial, the treatment to be studied, how the trial will work, risks and benefits. The form also explains how you will be monitored, potential side effects of the treatment, the current standard of care for your type and stage of cancer, the safeguards in place to protect you, how to withdraw from the trial, and a detailed list of the costs the trial sponsor will cover.

The trial’s medical team or administrator will go through the information with you. It’s very important to get clear answers to all your questions. Signing the Informed Consent form does not lock you in to the trial or to continue your participation. If you decide you no longer want to be involved, you may withdraw at any time and return to the standard of care.

Signing the form also does not guarantee you a spot in the clinical trial. Each research study has its own unique eligibility criteria, such as cancer type, subtype, stage, biomarker or treatment history. Your age, gender and any additional health conditions may also be factors.

Participating Offers Potential Benefits

Receiving your cancer treatment through a clinical trial may offer you the following:

  • Access to state-of-the-art cancer treatment that is not available outside clinical trials.
  • A higher level of care from being monitored by the clinical trial’s medical team in addition to by your regular oncologist.
  • Early intervention in treating side effects or addressing any complications, due to extra medical attention.
  • A role in advancing cancer research by helping to improve treatment options for future patients.

As with any cancer treatment, a clinical trial presents potential risks and side effects. It may require more medical appointments and/or tests than you would ordinarily have scheduled. Ask in advance to make sure you’ll be able to rearrange your schedules for work, school, family commitments and other obligations to accommodate the appointments required to meet the trial’s protocol.

Is a Clinical Trial Right For You?

Deciding whether to pursue a clinical trial as a treatment choice is not easy, and the element of uncertainty can cause some anxiety. Ask questions, consult with your doctor and consider getting a second opinion. You can also reach out to current or former clinical trial participants through local or online cancer support groups, as well as conduct your own online research.

The trial coordinator will know all aspects of the study and can help address any concerns. For example, you can ask the coordinator to provide additional information or printed materials, such as results from previous phases of the trial and the trial sponsor’s track record on cancer drug development. Find out if the investigational drug will be available to you post-trial (and at what cost) if you’re responding to it and how your care will be transitioned back to your current doctor.

This is a deeply personal decision only you can make. But now that you’ve found the true and false of clinical trials, you have the knowledge you need to give this treatment option the consideration it deserves.

 

The Four Phases of Clinical Trials

Clinical trials are traditionally designed in four phases, and each phase provides the building blocks of knowledge for the next phase. This approach allows researchers to ask and answer questions in a way that produces the most reliable information and provides the most protection of trial participants. The process also ensures that only treatments that have been rigorously studied are approved for the public.

Phase I evaluates a new drug (or other type of treatment) to see if it is safe for use in humans. The goal is to determine how the drug should be given, how often and at what dosage to be most effective for killing diseased cells while causing the fewest side effects.

Phase II determines how well a treatment works and how safe it is in a greater number of patients.

Phase III compares the new treatment 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 for the market to gather more information about a drug’s effect in different populations and learn about side effects that may occur with long-term use of the drug.

The time it takes for the FDA to approve new therapies has been shortened considerably. Previously, approvals took about 10 years. Recently, based on successes of other trials, researchers have begun investigating and conducting seamless trials that begin in earlier phases. Today, the FDA considers approvals at any phase of research, including as early as Phase I trials, and approves therapies before many other organizations. These advances give patients access to life-saving treatments sooner.

 

 

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