Clinical Trials Are at the Heart of All Medical Advances

Mary Crowley Cancer Research serves as a niche within healthcare science that conducts clinical trials to determine the safety and effectiveness of investigational drugs intended for humans.  To generate knowledge that will lead to improved health outcomes, it is well substantiated that EVERY approved treatment available today is the direct result of clinical research.  In fact, most of the staples of modern medicine (antibiotics, polio vaccine, HIV and cancer drugs) in use today were still unknown to physicians over 60 years ago.

Mary Crowley has been at this vital forefront for over 20 years, conducting first-in-human testing on hundreds of discoveries, resulting in 18 FDA-approved targeted drugs that are now globally available for cancer patients.  This is especially remarkable due to the fact that a new cancer agent is typically studied an average of six years before it makes it to a clinical trial for patients.  It takes an average of eight years from the time an investigational cancer agent enters clinical trials until it is finally approved by the FDA.  Why so long?  To be sure it is safe and effective, researcher study each new agent in multiple clinical trials.

In the last two decades, scientists have uncovered genetic changes that lie at the root of cancers.  Researchers are now working to identify all of the genes responsible for the growth of cancer.  Because each patient’s cancer is unique, a complex process is required to align or personalize each patient to the most applicable clinical trial, an expertise most often found in research centers like Mary Crowley. 

With clinical trials at the heart of medical advances, still fewer than 5% of adults with cancer will take part in a clinical trial, while 70% of children participate in clinical research.  This is one reason why survival rates for childhood cancer have increased (Source: American Cancer Society).

HOW PARTICIPATING IN A CLINICAL TRIAL MAY HELP YOU

• Access to promising new approaches often not available outside the clinical trial setting
• Proximity to expert medical care at leading healthcare facilities during your clinical trial
• Advancement of medical research by the knowledge gained from your participation

SOME POTENTIAL DISADVANTAGES OF PARTICIPATING IN A CLINICAL TRIAL

• The agent being tested in the clinical trial may not work and you may experience side effects not previously known to the researcher
• The clinical trial may require increased monitoring to ensure your continued safety which may require more frequent visits at the clinic
• The investigational agent may not be available to you right away once the clinical trial is finished

COMMON PATIENT QUESTIONS 

What are Clinical Trials?

Clinical trials or research studies for cancer utilize patient volunteers to help investigate different ways to treat or manage cancer.  Clinical trials involve the use of investigational or study therapies and their delivery methods. Each study tries to answer specific scientific questions about different ways to prevent, diagnose, treat or manage the type of cancer the investigational therapy is testing.

Why are Clinical Trials Important?

Clinical trials contribute to the overall knowledge and progress made in developing therapies for diseases, such as cancer. These research studies are conducted to determine if an investigational therapy or delivery method is safe and effective and works better than current treatments. It is hoped that patients who agree to participate may benefit from the research study and will receive standard supportive treatment as well.  Everyone who participates in a clinical trial will add to the knowledge about cancer and therefore improve future cancer care for everyone.

How are Clinical Trials Structured?

In Phase I clinical trials, researchers study the safety of a new investigational therapy or combination of therapies in a small group of people (15 to 50) for the first time to evaluate its safety, determine a safe dose and see how the new investigational therapy affects the human body through the identification of side effects.

In Phase II clinical trials, the investigational therapy is tested in a larger group of people (50 to 100) to measure its effectiveness on a certain disease such as a specific cancer and to further evaluate its safety and effects on the human body.

In Phase III clinical trials, the investigational therapy is tested in large groups of people (100 to 1000’s) to confirm its effectiveness, monitor side effects, compare it to approved standard treatments and collect information that will allow the investigational therapy to be used safely. 

In Phase IV clinical trials, the investigational therapy continues to be tested after it has been approved by the Food and Drug Administration (FDA) and communicated to the public. Researchers collect information about its effect in various populations and about any side effects associated with long-term use.

What Happens During a Clinical Trial?

If a patient is eligible and agrees to participate through signing an Informed Consent, the patient may receive an experimental therapy or a standard-of-care treatment, depending on the type of clinical trial. During a trial, patients are monitored by a team of healthcare professionals.

This team will give the patient specific instructions about the trial, required testing and additional physician visits. Throughout the clinical trial, the patient comes first. If there is no improvement or the patient experiences intolerable side effects, the physician or patient can decide to discontinue trial participation and resume other treatment options.

Does It Cost Money To Participate In A Clinical Trial?

Clinical trial participants do not have to pay for the actual cost of the investigational therapy received during the trial or the associated medical or nursing care. However, clinical trial participants may have to undergo some procedures while participating in a clinical trial that are not considered part of the trial cost, and therefore must be billed to the insurance company. Depending on specific insurance coverage, the trial participant may be required to pay a percentage of these costs, or copays.  For those who do not have medical insurance, there may be programs to assist with paying some of these out-of-pocket costs.  For more detailed information about out-of-pocket costs, click HERE.

Why Do Some Cancer Patients Choose to Participate in Clinical Trials?

Some cancer patients may participate because they are hoping for a possible cure and longer life or a way to feel better. Other patients find that the current standard therapies are not optimal for their cancer and desire to participate in a research study in the hope that they might receive an investigational therapy. Whatever the reason, participation could make a difference in a patient’s future, as well as in the lives of future cancer patients.

What if I Decide Not to Participate or Decide to Withdraw From a Clinical Trial?

Taking part in a clinical trial is voluntary.  Patients may choose not to participate in a clinical trial, or they may stop participation at any time. Patients who you make this choice will not be penalized or lose any benefits they may otherwise have received.  Patients who decide not join a study may have other choices for treatment.  All patients are advised to speak with their Primary Physician and Oncologist about the best options in their particular situation, including the associated risks and benefits. 

How Do I Know If I Should Participate in a Clinical Trial?

The decision to participate in a clinical trial is personal for each patient. Mary Crowley advises all patients to seek the help of their physician and family members. Those who are interested in participating in a clinical trial will receive extensive information related to the investigational therapy and the details of the clinical trial before making the decision to move forward.

Are There Risks Involved in Participating?

Because the investigational therapies in clinical trials are still under evaluation, the therapies may not be better than current standard drugs or treatments. Patients may also experience side effects that are worse than those of current standard drugs and treatments. Additionally, health insurance companies or managed care providers may not cover all of the patient care associated with a clinical trial. All of these factors should be discussed thoroughly with the patients’ physician and family before deciding whether to participate in a clinical trial.

Are There Benefits Involved in Participating?

Trial participants have access to new cancer options that are generally not available outside of a clinical trial. The investigational therapy may be found to be more effective than standard therapy, and trial participants would be the first to benefit from it.  Even without direct benefit, each research participant will be helping future cancer patients.

Who Do I Call if I Have Questions or Problems during a Clinical Trial?

If a patient has questions about a specific clinical trial, or if a patient believes he has been injured because of participation in a clinical trial, the patient should contact the Physician Investigator. The physician’s contact information is on the first page of the Mary Crowley Informed Consent Form. 

At Mary Crowley, all clinical trials are reviewed by the Mary Crowley Cancer Research Institutional Review Board (IRB), and their telephone number is 1-800-359-8501. Research participants who have questions about patient rights should contact the IRB.  For questions or concerns regarding potential conflicts of interest with a Physician Investigator or a staff member, please send a confidential email to the Conflicts of Interest Committee at conflicts@marycrowley.org.

How Do I Learn More About a Specific Clinical Trial?

Through a process called Informed Consent, each clinical trial candidate will learn the key facts about their particular clinical trial before making a decision to participate. Each clinical trial participants will be assigned to a Physician Investigator who will explain the purpose and requirements of the trial, including any potential risks and side effects. Patients who agree to participate in a clinical trial will review and sign an Informed Consent Form that outlines the clinical trial details prior to participating.

How Do I Get More Information?

For more information about clinical trials at Mary Crowley, please email info@marycrowley.org. A Mary Crowley staff member will follow up to discuss the patient’s health history and determine if a clinical trial might be appropriate.

If a candidate is eligible to participate in a clinical trial, Mary Crowley staff members will contact the patient’s Primary Physician to plan an overall treatment approach involving both experimental and standard treatment.

What Is an Informed Consent?

In the clinical research setting, an Informed Consent is a document that details relevant information to candidates who are thinking about taking part in a clinical research trial. The document will outline the following information:

• the purpose of the clinical trial
• the procedures involved in the clinical trial
• the possible benefits and risks of taking part in the clinical trial
• the rights of people who take part in clinical trial research
• a reminder that taking part in clinical trial research is a choice
• alternatives to participating a clinical trial
• how the research team will continue to provide new information after a patient has decided to take part in a study which may cause the patient to change his/her mind about participation

After learning about a particular trial, the Physician Investigator or their staff will answer any questions. Patients should only agree to take part in a trial once they clearly understand all the details. Patients are advised to discuss the decision with their primary physician, family, and friends. A patient who agrees to take part in the clinical trial must sign an Informed Consent Form. The Informed Consent is valid throughout the duration of the clinical trial, which means when investigators learn new information, even after the clinical trial has begun, they are obligated to share it with the patient.

Are Clinical Trials Only for Patients with No Other Options?

NO. There are trials for every type and stage of cancer. For many cancers, a trial can even be the first option. It is important, however, for a patient to have a very open and honest discussion with their Primary Physician or Oncologist about the goals and expected outcome of the clinical trial.

What is Molecular Testing, and How Is it Used in Clinical Trials?

A Molecular Panel Test provides a genomic profile of a patient’s tumor, identifying the molecular growth drivers of that particular cancer. This information helps Physician Investigators match a patient to the most appropriate clinical trial designed to target the particular cancer driver that is making the cancer grow.

If I Live a Long Distance from Mary Crowley, Can I Still Participate in a Mary Crowley Clinical Trial?

Yes, Mary Crowley sees patients from throughout the United States and even foreign countries. For assistance with travel or clinical trial costs, please contact 972-566-3000 or email us at information@marycrowley.org.