Clinical Trials

This is just a small list of Clinical Trials.
See your health care team to learn more about clinical trails and what trials are available in your area.

Introduction
What is a Clinical Trial?
Finding a Clinical Trial
Choosing a Clinical Trial
Who pays for clinical research?
Should you participate in clinical research?
Questions to ask

Introduction

The purpose of a clinical trial is to determine whether a new treatment option is safe, effective and a better alternative to current standard care methods. Volunteer participation by women of all races, ages and ethnicities is essential, if researchers are to find the best treatment regimens.

What is a Clinical Trial?

A clinical trial is a strictly monitored process. Before a pharmaceutical company can initiate testing in human subjects in a hospital or clinical setting, it must conduct extensive pre-clinical or laboratory research. This research typically involves years of experiments in animal and human cells. The compounds are also extensively tested in animals. If this stage of testing is successful, a pharmaceutical company provides this data to the Food and Drug Administration (FDA), requesting approval to begin testing the drug in humans. This is called an Investigational New Drug application (IND).
Before enrolling in a clinical trial, you will undergo the informed consent process. At this time, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty, even after signing the consent forms.

Clinical trials have four distinct phases:

	Phase One trials use a small number of human subjects to test a new treatment that has already undergone rigorous testing on animals. Participants usually have advanced cancer that hasn’t responded to standard treatments. At this stage, researchers can only predict outcomes and any possible side effects on humans. During Phase One trials, investigators determine the most effective dosage and application methods. Some cancer patients have seen improvement in Phase One trials.
	Phase Two trials involve a larger group of patients, in which researchers build on what they learned in Phase One. Because more subjects are involved, investigators may discover less common side effects, and will continue to evaluate the safety of the treatment.
	Phase Three trials may involve over a thousand patients, often at several medical institutions. During this phase, the study treatment is compared to and/or combined with standard modalities (treatment methods). Some participants, the "treatment group," are given the experimental treatment and others in a "control group" are given the current standard treatment, so researchers can compare outcomes in the two groups.
	Phase Four trials occur after the treatment has been put on the market to monitor effects of long-term usage, and how it affects certain population groups. If dangerous side effects are found, the drug or treatment is taken off the market.

Finding a Clinical Trial

Clinical trial investigators are eager to recruit study participants and use a variety of resources to get the word out.

Ask your doctor or cancer specialist; they may know of clinical trials for which you might be eligible.

Check your local newspaper for advertisements seeking study volunteers in your area.

Read national newspapers, magazines and journals for current and future research.

Contact a pharmaceutical company developing new cancer drugs. They can refer you to clinical trial sites.

Use the Internet to view hundreds of ongoing clinical trials involving many types of cancer. Below are are a few other web sites that list ongoing clinical trails.

National Cancer Institute - Information about cancer research studies.
ClinicalTrails.gov - National Institutes of Health, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members and members of the public current information about clinical research studies.
CenterWatch - clinical trials listing service, including some M. D. Anderson trials.

Choosing a Clinical Trial

Before participating in a clinical trial, discuss it with your doctor or cancer specialist. Make sure to get all the details of the intended benefits and possible side effects before signing any consent forms. You can leave a clinical trial at any time, and will not be penalized for doing so.

Here are some issues to consider before enrolling in a clinical trial:

Eligibility - clinical trial investigators follow strict criteria to recruit study volunteers. Recruitment forms list "inclusion criteria": things like disease type, treatment status, medical history, age range, gender, ethnicity and other factors necessary to join the trial. Forms may also list what investigators aren’t looking for, known as "exclusion criteria."

Benefits - although clinical trials offer no guarantees, scientists have a strong belief that the study drug or treatment will provide benefits equal to or better than standard care methods. If that is the case, study volunteers will be the first to receive this new modality, and will continue to receive medical checkups to monitor their progress.

Risks - the clinical trial process is not risk-free. Study investigators have anticipated many of the side effects, but not all can be known ahead of time. If a new treatment exhibits potentially dangerous side effects, the trial is immediately discontinued and participants receive follow-up care to ensure they were not harmed. Remember, most standard cancer treatments do have side effects, which include nausea, hair loss and compromised immune systems.

Duration - clinical trials can last anywhere from a few weeks to several years. Some require frequent clinic or hospital visits, which can interfere with your normal routine; others only need monthly or quarterly monitoring. Some studies, particularly Phase Three, are conducted at several locations, but if you don’t live near a trial site, you may have to consider long travel times or temporary relocation to participate.

Cost - It is essential to determine what your out-of-pocket expenses will be in a clinical trial before enrolling! You may be responsible for some or all of the costs involved, including blood work, X-rays, and other procedures. Sometimes, a biotechnology or pharmaceutical company or other research grant will sponsor a clinical trial and pay some, but usually not all expenses.
Note: Usually in Canada all costs are covered in a clinical trial. Some clinical trials will even pay you to be in them. Check with the trial administrator first.

You also need to call your health insurance carrier or managed care provider to see whether they cover clinical trials. Insurance companies may deny coverage if the treatment is considered experimental, but they might pay if the study treatment is similar to something the patient would receive outside a clinical trial.

The fees that are covered differ from country to country.

Should you participate in clinical research?
Patients considering participating in clinical research should talk about it with their physicians and medical caregivers. They also should seek to understand the credentials and experience of the individuals and the facility involved in conducting the study.

Questions to ask:

	How long will the trial last?
	Where is the trial being conducted?
	What treatments will be used and how?
	What is the main purpose of the trial?
	How will patient safety be monitored?
	Are there any risks involved?
	What are the possible benefits?
	What are the alternative treatments besides the one being tested in the trial?
	Who is sponsoring the trial?
	Do I have to pay for any part of the trial?
	What happens if I am harmed by the trial?
	Can I opt to remain on this treatment, even after termination of the trial?

Possible benefits of clinical trials include:

	If a new treatment approach is proven to work and you are taking it, you may be among the first to benefit.
	By looking at the pros and cons of clinical trials and other treatment choices, you are taking an active role in a decision that affects your life.
	You have the chance to help others and improve cancer treatment.

Possible drawbacks:

New treatments under study are not always better than, or even as good as, standard treatment.

Even if a new treatment has benefits, it may not work for you.

In a study, if you are randomly assigned to have standard treatment instead of the new treatment being tested, it may not be as effective as the new approach.

Health insurance and managed care providers do not always cover all patient care costs in a study.

See your health care team to learn more about clinical trails and what trials are available in your area.