Clinical Trials
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Clinical Trials | How? | Where? | Why?

What?

Describes what a clinical trial is,
the different types and who is eligible for them.

CURRENT CLINICAL TRIALS

A CLINICAL TRIAL is a study which is conducted to find better ways to detect, diagnose, treat, or prevent a disease. The goal of CLINICAL TRIALS is to find out if new treatments might be more effective than treatments already in use for diseases.

If you decide to become involved in CLINICAL TRIALS it will possibly turn your diagnosis of breast cancer into an experience that might just help other women once they are also diagnosed with breast cancer.

Any CLINICAL TRIALS, whether they be sponsored by the National Cancer Institute (NC) or other groups always have safeguards built in. Computers are used to chose treatments on a random basis and all hospitals have committees who review each and every treatment plan in order to ensure patient safety.

Patients always have a right to refuse treatments but when they do agree to participate in CLINICAL TRIALS they must give full and informed consent before they are allowed to participate. Enrollment in these trials will be a long-term commitment . . you will be followed for the rest of your life so it can be seen how the treatments affect you during your lifetime.

PHASES of CLINICAL TRIALS

There are three phases of clinical trials.

The FIRST PHASE is a study of people to evaluate if a new drug should be given by mouth, injected into the blood or injected into the muscle. It also evaluates how often and what does is safe and will normally just enroll a few patients to start with.

The SECOND PHASE usually will focus on a certain type of cancer and will also be used to evauluate the efficiency and the safety of the drug.

The THIRD PHASE will compare the current standard of treatment to the new drugs which are being tested and/or to a new surgical procedure. Participants of the CLINICAL TRIALS will either be assigned to the current standard treatment or to the new treatment group, which is called randomization. And in this phase it usually involves large numbers of people and the tests might be conducted at cancer centers, clinics or doctor's offices throughout the United States.

WHO IS ELIGIBLE?

Now you are asking, "Am I eligible for any CLINICAL TRIALS?" Yes, you will be eligible . . . you just need to ask your doctor about any CLINICAL TRIALS that he feels you might be qualified for. If your doctor is not sure of what trials you might qualify for, you can contact the National Cancer Institute (NCI). There are also many university hospitals, or teaching hospitals, that also conduct CLINICAL TRIALS. And there is also a program which is called Cancer Center Outreach Program (CCOP) that you can contact. CCOP links community hospitals to some of the larger medical centers which also conduct CLINICAL TRIALS

Once you find a CLINICAL TRIAL that you feel you might be qualified for, the participating doctors will have to determine your eligibility for that particular trial, as each one has its own set of criteria and guidelines in order for you to be admitted to it. If and when the doctors find that you are eligible, you will need to sign consent forms and undergo medical tests. And then you will be assigned to receive a specific treatment.

The following information was supplied by Musa Mayer:
If a drug shows success with cancer in the lab, it becomes an extremely time consuming process, that occurs over many years to go from lab to FDA approval.

When a drug leaves the animal lab, it must be carefully tested for dosage, toxicity, and efficacy in humans. There are many requirements that must be satisfied before a new drug is approved for testing in humans. Once the drug is in clinical trials and has moved from Phase I (dosage, safety) to Phase II (efficacy, safety), it often then moves into trials for a variety of different cancers for which it may have effectiveness.

Phase I trials are done in small numbers of patients, and usually don't take very long, since they are looking at safety and pharmacokinetics issues (like how the drug is metabolized, how long it takes to clear the body, etc) which are measured during the trial itself. These trials are usually done stepwise, with escalating dosage levels.

Phase II trials, by comparison, look at endpoints (ways in which the success of the drug will be measured) like time to disease progression or even survival, as well as tumor response, a more immediate measure--and so the results can take many months to years before they are complete, even if accrual to the trial occurs quickly.

Once Phase II trials are complete, drug companies must submit the new data to FDA. If given the green light, they then focus their energies on one or more large Phase III trials in which patients are randomly assigned to receive either the new drug or the best available treatment, so that a comparison can be made that isn't biased by expectations or other factors. Ideally, though this is often not possible, neither patients nor investigators would know which patients were in the experimental arm of the trial, and which were in the control arm. This is called "blinding."

And again, the endpoints, which may be survival (a longer term endpoint, but considered the "gold standard"), time to progression, tumor response or clinical benefit (a measure that takes quality of life into account), must be measured. Only after these trials are completed and the data compiled and submitted, can the FDA evaluate the findings and make a decision about approval for the specified indication for which the drug was tested. Later approvals may be made for other indications, if evidence warrants--but usually only Phase II and III trials must be repeated for the new indication.

The best way to gain early access to investigational drugs is through participation in clinical trials. Too few metastatic breast cancer patients make this choice, often because they don't realize it is available or are being treated by physicians who are outside the cooperative oncology groups or major teaching hospitals that sponsor these trials. But also, there are persistent attitudes, especially among minority populations, about patients being exploited or being "experimented on" that have hampered breast cancer research. And there have been significant barriers, economic and otherwise, to access. Virtually every drug used in breast cancer treatment is tested and approved first in metastatic breast cancer patients. There's no doubt that if most women with mets participated in trials, the pace of drug development and research advances would greatly accelerate, and everyone would benefit.

SOURCES

Susan Love M.D.
Musa Mayer
NCI

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