For cancer patients, clinical trials mean hope. Hope in a cancer-free world and in better, more targeted ways to prevent, detect, treat and cure individual cancers.
The OSUCCC – James has more than 500 open clinical trials at any given time, with some of the world’s latest discoveries available to clinical trial patients right here in Columbus, Ohio. In fact, patients have access to more cancer clinical trials here than at nearly any other hospital in the region, as well as access to some of the most advanced, targeted treatments and drugs available.
The OSUCCC – James is one of only a few comprehensive cancer centers funded by the National Cancer Institute (NCI) to conduct phase I and phase II clinical trials on novel anticancer drugs. These trials go only to centers that demonstrate an exemplary capacity for research and clinical care, the expertise to deliver the latest in treatments, and the infrastructure to interpret and track treatment results.
Additionally, Ohio State has more than 300 cancer researchers dedicated to understanding what makes each patient’s cancer grow, move, metastasize or reoccur. Because of the OSUCCC – James’ NCI phase I and II approvals, these experts can move research discoveries into clinical trials and make them available to patients sooner.
Find a clinical trial at the OSUCCC – James today.
What Are Clinical Trials?
Clinical trials are research studies that involve people. They are the final step in a long process that begins with research in a lab, in some cases right here at Ohio State. Most treatments we use today are the result of past clinical trials.
Cancer clinical trials are designed to test new ways to:
- Treat cancer
- Find and diagnose cancer
- Prevent cancer
- Manage symptoms of cancer or side effects from its treatment
Any time you or a loved one needs treatment for cancer, clinical trials are an option to think about. Trials are available for all stages of cancer. It is a myth that they are only for people who have advanced cancer that is not responding to treatment.
Every trial has a person in charge, usually a doctor, who is called the principal investigator. The principal investigator prepares a plan for the trial, called a protocol. The protocol explains what will be done during the trial. It also contains information that helps the doctor decide if this treatment is right for you. The protocol includes information about:
- The reason for doing the trial
- Who can join the trial (called “eligibility requirements”)
- How many people are needed for the trial
- Any drugs that will be given, how they will be given, the dose, and how often
- What medical tests will be done and how often
- What types of information will be collected about the people taking part
Why Are Clinical Trials Important?
Clinical trials are key to developing new methods to prevent, detect and treat cancer. It is through clinical trials that researchers can determine whether new treatments are safe and effective and work better than current treatments. When you take part in a clinical trial, you add to our knowledge about cancer and help improve cancer care.
Types of Clinical Trials
There are several types of cancer clinical trials, including treatment trials, prevention trials, screening trials, and supportive and palliative care trials. Each type of trial is designed to answer different research questions.
Treatment Trials
Most cancer clinical trials are treatment studies that involve people who have cancer. These trials test new treatments or new ways of using existing treatments, such as new drugs, vaccines, approaches to surgery or radiation therapy, or combinations of treatments.
Some treatment trials involve testing cancer cells for the presence of specific molecular markers. These markers can include changes in certain genes or proteins. These changes may help to further classify cancers and certain treatments may target them. So it is important to know whether they are present.
Treatment trials are designed to answer questions such as:
- What new treatment methods can help people who have cancer?
- What is the most effective treatment for people who have cancer?
- Does the new treatment work as well as the old treatment?
- What are the new treatment’s side effects?
For information about taking part in treatment trials, see the booklet Taking Part in Cancer Treatment Research Studies.
Prevention Trials
Cancer prevention trials are studies involving healthy people. In most prevention trials, the participants either do not have cancer but are at high risk for developing the disease or have had cancer and are at high risk for developing a new cancer. These studies look at cancer risk and ways to reduce that risk.
There are two kinds of prevention trials: action studies and agent studies.
Action studies ("doing something") focus on finding out whether actions people take — such as exercising more or eating more fruits and vegetables — can prevent cancer.
Agent studies ("taking something") focus on finding out whether taking certain medicines, vitamins, minerals or dietary supplements (or a combination of them) may lower the risk of a certain type of cancer. Agent studies are also called chemoprevention studies.
Researchers who conduct these studies want to know:
- How safe is it for a person to take this agent or do this activity?
- Does the new approach prevent cancer?
For information about taking part in prevention trials, see the booklet If You Want to Find Ways to Prevent Cancer…Learn About Prevention Clinical Trials.
Screening Trials
The goal of cancer screening trials is to test new ways to find disease early, when it may be more easily treated. An effective screening test will reduce the number of deaths from the cancer being screened.
Researchers who conduct cancer screening studies want to know:
- Does finding disease earlier, before people have any symptoms, save lives?
- Is one screening test better than another?
- Do a large number of people who receive the screening test undergo unnecessary follow-up tests and procedures?
Quality of Life/Supportive Care/Palliative Care Trials
These trials look at ways to improve the quality of life of cancer patients, especially those who have side effects from cancer and its treatment. They find new ways to help people cope with pain, nutrition problems, infection, nausea and vomiting, sleep disorders, depression and other health problems.
These trials might test drugs, such as those that help with depression or nausea. Or, they might test activities, such as attending support groups, exercising or talking with a counselor. Some trials test ways to help families and caregivers cope with their own needs, as well as those of the person with cancer.
Researchers who conduct these studies want to know:
- How does cancer and its treatment affect patients and their loved ones?
- What can improve the comfort and quality of life of people who have cancer?
Clinical Trial Phases
A clinical trial is one of the final steps in a long and carefully controlled research process that begins in the laboratory, where scientists develop and test new ideas. If a new approach seems to be safe and effective there, it may then be tested on people in the following phases:
Phase I
Purpose:
- To find a safe dose
- To decide how the new treatment should be given (by mouth, in a vein, etc.)
- To see how the new treatment affects the human body
Number of people taking part: 15 to 30
Phase II
Purpose:
- To determine if the new treatment has an effect on a certain cancer
- To see how the new treatment affects the human body
Number of people taking part: Less than 100
Phase III
Purpose:
- To compare the new treatment (or new use of a treatment) with the current standard treatment
Number of people taking part: From 100 to several thousand
Insurance Coverage During a Clinical Trial
In April 2008, at the urging of the OSUCCC – James, the Ohio General Assembly introduced and passed legislation requiring fully-funded Ohio-based insurance companies to pay for routine care costs for cancer patients enrolled in clinical trials. The law went into effect October 4, 2008.
On February 26, 2009, U.S. Senator Sherrod Brown (D-OH) announced legislation that would protect access to treatment options for patients diagnosed with cancer. Brown’s Cancer Clinical Trials Act prevents insurance companies from denying patients participating in clinical trials coverage for the services they would otherwise receive under their health care plans. Companion legislation has been introduced in the U.S. House of Representatives by Congressman Steve Israel (D-NY).
A federal policy change is currently needed to ensure that cancer patients covered by self-insured Employee Retirement Income Security Act plans and other plans limited by state laws maintain benefits and services if individuals enroll in a clinical trial.
Is a Clinical Trial Right for You?
Deciding whether to participate in a clinical trial is an important personal decision. Find out if a clinical trial is right for you.
Clinical Trial Safety
Federal rules help ensure that clinical trials are safe. Your rights and safety are protected through informed consent. Informed consent is more than just reading and signing a piece of paper. Informed consent is a process of:
- Explanations and discussions throughout the study to help you make decisions about joining or continuing in the study
- Written information about the clinical trial including:
- The purpose of the study
- Potential risks and benefits
- Treatment procedures and schedule
- Other treatments available to you
In addition, you will be protected through:
- Careful review and approval of the clinical trial protocol by:
- Scientific experts
- An institutional review board (IRB)
- Ongoing monitoring of the trial by:
- The IRB
- Data and Safety Monitoring Boards (DSMBs) for phase III trials
- The organization sponsoring the trial
- The research team
Clinical Trial Risks
Like all treatment options, clinical trials have possible benefits and risks. Below are some risks when enrolling in a clinical trial.
- The new treatment may not be better than, or even as good as, the standard treatment.
- New treatments may have side effects that doctors do not expect or that are worse than those of the standard treatment.
- You may be required to make more visits to the doctor than if you were receiving standard treatment. You may have extra expenses related to these extra visits, such as travel and child-care costs.
- You may need extra tests. Some of the tests could be uncomfortable or time consuming.
- Even if a new treatment has benefits in some patients, it may not work for you.
- Health insurance may not cover all patient care costs in a trial.
Leaving a Clinical Trial
Participation is 100 percent voluntary. You have the legal right to quit any clinical trial, at any time, for any reason. When withdrawing from a clinical trial, the participant should let the research team know about it along with the reasons for leaving the study.
Questions to Ask Before Enrolling in a Clinical Trial
Before beginning a clinical trial, all volunteers are given a detailed explanation of the study. If you are considering participation, you may want to ask these questions:
About This Trial
- What is the purpose of the trial?
- Why do the researchers believe that the treatment being studied may be better than the one being used now? Why may it not be better?
- How long will I be in the trial?
- What kinds of tests and treatments are involved?
- How will the doctor know if the treatment is working?
- How will I be told about the trial’s results?
- How long do I have to make up my mind about joining this trial?
- Who can I speak with about questions I have during and after the trial?
- Who will be in charge of my care?
- Is there someone I can talk to who has been in the trial?
Risks & Benefits
- What are the possible side effects or risks of the new treatment?
- What are the possible benefits?
- How do the possible risks and benefits of this trial compare to those of the standard treatment?
Rights
- How will my health information be kept private?
- What happens if I decide to leave the trial?
Costs
- Will I have to pay for any of the treatments or tests?
- What costs will my health insurance cover?
- Who pays if I’m injured in the trial?
- Who can help answer any questions from my insurance company?
Daily Life
- How could the trial affect my daily life?
- How often will I have to come to the hospital or clinic?
- Will I have to stay in the hospital during the clinical trial? If so, how often and for how long?
- Will I have to travel long distances?
- Will I have checkups after the trial?
Comparing Choices
- What are my other treatment choices, including standard treatments?
- How does the treatment I would receive in this trial compare with the other treatment choices?
- What will happen to my cancer without treatment?