Understanding Clinical Trials

What is a Clinical Trial?

Clinical trials are research studies that involve patient volunteers who participate in the testing of new therapies or provide new data on current treatments. The purpose is finding new, more effective cancer treatments, understanding current diseases and treatments better, and increasing detection and prevention of cancer. Each study is designed to answer specific scientific questions and help find potentially better ways to prevent, diagnose, or treat cancer. Maryland Oncology Hematology participates in Phase I, II, III, and IV studies, testing drugs at a variety of stages and offering cutting-edge research.

Our Clinical Research Mission

MOH is committed to delivering high quality, ethically conducted, world class clinical research trials and superior research support services to promote the scientific advancement of cancer care as we offer our patients access to breakthrough treatments close to home.

The Maryland Oncology Hematology Clinical Research Program

Through our affiliation with The US Oncology Network, one of the largest and most reputable community-based research networks in the world, MOH has access to some of the most promising new trials being offered. We also participate in National Cancer Institute (NCI) sponsored research.

 At MOH  we are proud of our role in the research and development of vital new cancer therapies. We are committed to bringing clinical trials to our community, offering patients an opportunity to help shape the future of cancer treatment, while benefiting from the very latest in clinical trials.

FACT:

  • All trials are voluntary
  • Not all clinical trials are treatments and drugs
  • Research is important for the future
  • Clinical trials are an option during all stages of the disease and treatment time.

What Happens During a Clinical Trial?

When someone decides to participate in a clinical trial, the care they receive is much like the care they would otherwise receive. However, there is often additional monitoring for the purpose of learning about potential side effects and benefits of the clinical trial. Some trials simply test a study regimen, and all participants receive this same regimen. Other trials may compare a study regimen to the standard treatment. In this type of study, participants are randomly assigned to receive one or the other, but be assured that both treatments will meet the current standards of care.

Why is Research Important?

Clinical trials are a vital part of the process in finding new targeted treatments. These research studies are conducted to determine if a study drug is safe and effective. Today’s research will guide the improvements for tomorrow’s cancer care. By participating in a clinical trial, you are not only possibly receiving cutting edge treatments, but also providing valuable information for future research and treatments.

One of the largest obstacles in finding new treatments is that not enough people participate in them. According the American Cancer Society, Only 5% of adults with cancer participate in them. Meanwhile, almost 60% of children participate in clinical trials, allowing survival rates for childhood cancer to increase dramatically in the last few decades.

What is Informed Consent?

Informed consent means that patients must be told the key facts about a clinical trial before deciding whether to take part. If the patient agrees to take part, the informed consent process involves signing a form that details the entire clinical trial, possible side effects, and potential risks and benefits. Participants may withdraw their decision to participate at any time for any reason.

Should I Participate in a Clinical Trial?

The decision to take part in a clinical trial is a personal one. You may wish to talk to your family and loved ones, as well as members of your health care team, before deciding. As with all current standard treatments, there can be possible risks as well as benefits from taking part in clinical trials. Study drugs may be found to be more or less effective than current standard treatments and have side effects not yet known. You will be informed of these risks as much as possible. Your health care team will give you the information you need to make the decision that is right for you.

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. Others find that the current standard therapies are not optimal for their cancer and wish to be among the first to participate in a research study and receive an investigational drug. Whatever the reason, participation could make a difference in a patient's future, as well as in the lives of future cancer patients.

Are Clinical Trials a Last Ditch Effort?

Many clinical trials are used simply to gather data, and are not used as treatment. Those that are treatments are not a last ditch effort. Clinical trials can be used during all stages of treatment and cancer in conjunction with normal treatment or on its own. Participation can make a difference in patient health and life.

How are Clinical Trials Structured?

Clinical trials are structured into four phases:

  • In Phase I clinical trials, researchers test a study drug in a small group of people (20 to 80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  • In Phase II clinical trials, the study drug is tested in a larger group of people (100 to 300) to further evaluate its safety in conjunction with its effectiveness.
  • In Phase III clinical trials, the study drug is tested in large groups of people (1,000 to 3,000) to confirm its effectiveness, monitor side effects, compare it to approved standard treatments, and collect information that will allow the study drug to be used safely.
  • In Phase IV clinical trials, the drug is tested after it has been marketed to collect information about its effect in various populations and about any side effects associated with long-term use.

Types of Cancer Treatments

  • Chemotherapy: Medications that reduce and slow cancer growth and spread, included targeted therapy
  • Radiotherapy: Internally or externally delivered radiation to inhibit cancer cell reproduction, and target and destroy cancerous cells.
  • Surgery: Removal of cancerous tumors and other obstructions
  • Hormone Therapy: Medications that aid or limit the presence or activity of hormones to control cancer growth
  • Immunotherapy: Therapy that aids the body’s own immune system to affect cancer cells

Not All Trials are Treatments or Drug Trials

Some clinical trials look for ways to detect, diagnose, prevent, or learn the extent of disease. Many of these include simple sample gathering and questionnaires. Others observe patients to further their knowledge on diseases or drugs already approved. This research is just as important as those that use treatment drugs, as the results can help to prevent and diagnose disease early on. Many non-drug related studies occur for cancer and non-cancer patients, so ask your doctor about participating in order to help further knowledge on these important subjects.

How is a Investigational Drug Tested Before Given to Patients?

Clinical trials involving treatment require drugs to be discovered or created, purified, described, and tested in labs before ever reaching human trials. According to the American Cancer Society, most cancer drugs are studied for at least 6 years before it makes it to clinical trials, with about 8 years of clinical trial studies until it is officially approved. This is one reason research is so important. They check for safety and effectiveness, using these years of research to tell if the cancer treatment really works and improves ones survival. At Maryland Oncology Hematology, we are dedicated to safe clinical practices and patient satisfaction and care.

Clinical Trials and Placebos

Many patients begin to feel better even just by thinking they are being treated. For this reason, placebos are used as a control group in order to make the results of the actual treatment more valid. It is important to state that placebos are rarely used alone in cancer research. If there is a treatment available that works, the placebo will be taken in conjunction with that treatment, while the experimental treatment is taken with the normal treatment as well. Placebos are never used in place of a treatment that is known to work. Sometimes, they compare a new treatment to a standard of care treatment by not revealing which treatment the participants are receiving, but with the guarantee that they are getting treatment that at the very least meets the current standard of care.

How to Prepare Before Your First Visit

Bring insurance information, photo ID, new patient forms, medications, and a list of any questions you may have. If you have visited before, but it is your first visit on a research trial, be sure to come with lots of questions, a loved one, and an open mind. A clinical research coordinator will walk you through the entire trial and anything else you may need in order to be and feel prepared to join that specific clinical research trial. Expect each trial to be different, but the level of care and attention shown by the MOH research team to be thorough and consistent with our core beliefs of patient care, along with your physicians, technicians, pharmacists, and all other practice providers. For more questions about your first visit to MOH, see our "What to Expect" page.

Who Pays?

This varies greatly between trials. Tests that are not part of standard care tend to be covered by the research study. The clinical research coordinator specified to that trial and your care will walk you through any and all billing questions you may have about your treatment before you consent to begin.

What are the Benefits?

Today, patients have more and more treatment options at all stages of treatment. Clinical trials not only propose possible benefit to the participants, but also to science and the people of the future. After all, clinical trials are simply just "Tomorrow’s Treatment Today."