Mendocino

by Mary Braddish O'Connor

We stood here years ago,

making promises before we had

a clue about love,

the price we pay

for saying yes. Before

we knew, we promised.

Whales swam far out,

blessing us, we thought,

with spouts of wedding lace

while we toasted them

from the rocky promontory,

wild ocean all around.

They're back again (it's March

again) and so are we,

without wine and crystal,

thinner now but just as happy,

clearer about what a promise

means. Last week a whale washed

onto the beach, collapsed into herself

until the last torn wave of the tail,

the big eye emptied.

She might have said, except

we already know (are learning),

in this tough year, without future,

without hope, the journey

is all we have.

Mendocino is printed with the permission of
Marty Johnson.

In the fast-paced competition of today's cancer drug market, the wonders of promising new drugs sometimes hit the popular media while they are still in the early stages of clinical testing. The public hears these drugs being touted as miracle cures by enthusiastic journalists or news anchors and see cured cancer patients giving testimonials to the drugs' effectiveness. Yet, when someone tries to learn more about these drugs he or she may not know where to start, especially when many experimental drugs have only a few numbers and letters for a name.

There are some new types of drugs that are showing exciting potential to slow or stop cancer growth, but none of these drugs is a cure-all and most are still being tested in clinical trials. New drugs must go through an extensive testing process to make sure they are safe and that they work for the disease they are meant to treat before they are approved for sale. The process can take many years to complete, from the start of the trial to final approval by the Food and Drug Administration (FDA).

It is possible to gain access to new cancer drugs by becoming a participant in a clinical trial, but gathering the necessary information on trials can be difficult and confusing. A basic understanding of how clinical trials work and familiarity with the terms used by doctors and researchers, can help someone who is considering joining a trial make an informed decision.

Phases of Clinical Trials

A clinical trial is a research study that tests a new drug or other treatment in people to determine whether it is safe and effective. Before a drug is tested in humans, years of preclinical experiments are done in the laboratory and in animals. If these tests are successful and the drug looks safe and promising, it is then tested in clinical trials. Clinical trials are normally done in three phases.

Phase I Trial

In Phase I trials, researchers test the safety of a new drug in a small number of healthy people. (Although some participants in phase I studies may have a type of cancer that does not have an "effective treatment," according to the National Cancer Institute web site.) The study is designed to determine how the drug is processed in the human body and what side effects there are at different dosages. Phase I studies usually last several months.

Phase II Trial

Once a drug is shown to be safe it is tested in larger numbers of people to determine its effectiveness and further study its side effects. Phase II studies may enroll up to several hundred people who have the disease the drug is intended to treat. The trials usually last several months to two years.

Phase III Trial

In Phase III trials, the drug is tested in several hundred to several thousand people. The purpose of Phase III trials is to learn more about the drug's effectiveness, side effects, the best dose to give, and the benefits of the drug over current treatments. These studies usually last several years and are often conducted at numerous locations nationwide and sometimes, worldwide. When the third phase of testing is successfully completed, the FDA carefully reviews all the findings from the trial and decides if the drug should be approved for sale.

Phase IV Trial

Phase IV trials, also called post-marketing studies, may be done after a drug is approved for marketing. These studies are done to obtain more information about the drug's safety and effectiveness, to compare it to other drugs on the market, and to study the quality of life of people taking the drug and the drug's cost-effectiveness.

How Clinical Trials are Planned

Clinical trials are usually sponsored by a pharmaceutical or biotech company, a government agency, or a research institution. The sponsor hires doctors to conduct the study. Doctors are usually paid on a per-patient basis. The medical care and treatment are often provided free, but this is not always the case. In some instances, medical insurance plans may pay some of the cost.

Each trial is headed by a doctor called the principle investigator, who prepares a plan for the study, called a protocol. The protocol explains:

* The reason for the study

* How many people will be included in the study

* Who is eligible for the study

* What treatment will be given to study participants

* What medical tests participants will have

* What information will be gathered

How Participants are Protected

Clinical trials are carried out according to the plan in the protocol. An independent Institutional Review Board made up of doctors, other health care professionals, and community or patient advocates must approve the protocol and monitor every aspect of the study to make sure participants' rights and safety are protected.

Before enrolling in a trial, participants must sign an informed consent form. Informed consent is the process of learning important facts about the trial before deciding whether or not to participate. It is important to carefully read the informed consent form, ask the doctor or nurse any questions about the trial, discuss the information with family or friends, and be sure the information is understood and acceptable before agreeing to participate. The informed consent form should include details about the study plan, what will be done in the trial and for how long, the treatment given in the study, the possible benefits of participating, any possible risks, other available treatments, and the fact that the participant can leave the trial at any time.

What Happens in a Trial

Clinical trials may take place in a medical center, hospital, community clinic, or doctor's office. Participants in a clinical trial work with a team of doctors, nurses, social workers, and other healthcare professionals. Participants are given a complete medical exam and other medical tests to evaluate their health and the status of their disease and to determine their eligibility for the trial. Most Phase II and Phase III trials are randomized. This means that one group of participants will receive the experimental treatment and the other group will receive the standard treatment for the particular type of cancer. A placebo is almost never given in cancer trials for which standard treatments exist. These trials are also usually blinded, meaning that the participants and those on the research team, including the doctor, do not know who is getting the experimental treatment.

Trial participants are monitored carefully and may have more tests and doctor visits than they would if they were not in the study. Participants are expected to follow instructions carefully and stay in contact with the research team. If participants experience serious side effects from the treatment, they may be taken out of the trial to protect their safety.

Deciding Whether to Participate

People considering participating in a clinical trial should talk about it with their doctors, healthcare providers, cancer support groups, family and friends. They should learn as much as possible about their disease and the effectiveness and risks of available treatments. They should look into the credentials and experience of the facility involved in conducting the study. It might also be helpful to get information about the company sponsoring the study and any competing drugs that are being tested. Although lifesaving drugs are developed by pharmaceutical companies, it is critical to remember that these are profit-making companies and that doctors and research facilities are paid to conduct clinical trials. Most important of all, carefully weigh all your options and seek the advice of healthcare professionals before making a decision.

Toni Rizzo has undergraduate degrees in biology and education, as well as training and certification as a Cytologist (specialist in cancer cellular diagnosis), and an MS degree in communication. She has worked in hospitals for 15 years, including the University of Utah Health Science Center and Medical School where she was supervisor of the Cytopathology Laboratory and Instructor in the Cytopathology Degree Program. For the past 10 years she has been a freelance medical and science writer, with articles published in numerous journals and magazines, including National Geographic World. She also reports on medical conferences, writes continuing education programs, and medical training programs for pharmaceutical companies.

Toni moved to Fort Bragg one year ago from Salt Lake City, Utah. She has one daughter in college and lives with two cats. She considers herself to be a community activist and is particularly interested in healthcare issues, especially in environmental causes of cancer and other diseases.

Clinical Trial information contained in this article can also be found on the National Cancer Institute's Website at http://cancerTrials.nci.nih.gov. NCI can be contacted at 1.800.4.CANCER.