Clinical trials: 5 things you should know

Clinical trials are at the core of MD Anderson’s mission to end cancer. They’re
how we discover new ways to prevent, diagnose and treat cancer.
Through volunteer patient participants, we can find new drugs and
treatment procedures that may benefit current and future patients.
They give patients access to cutting-edge treatments that are
sometimes offered at discount through a sponsor.

To better understand clinical trials and to dispel some
misconceptions, we spoke with Patrick Hwu, M.D., division head of Cancer
Medicine. Here are five things he wants you to know about clinical trials.

Clinical trials occur in phases

There are four phases of clinical trials, and each has its own
goal. Phase I clinical trials are the first time a new
drug is tested in human beings. We’re trying to find the safest dosage
and also which cancer types respond.

Phase II clinical trials focus on a specific cancer type and examine
how it responds to the experimental drug or procedure.

Phase III clinical trials test whether a new treatment is better
than the standard care. At this point, the drug or procedure goes to
the Food and Drug Administration (FDA) for approval, but the trial
isn’t done. A fourth phase (Phase IV trials) reviews the new
treatment’s long-term benefits and side effects.

Although a treatment moves through the phases, a patient does not.

Clinical trials don’t just examine new drugs

Although many clinical trials study new medicines, some study new
ways to dispense treatment, explore a new dosage or test a drug’s
success in treating different cancer types.

Clinical trials don’t limit your access to other care

If a clinical trial isn’t successful in treating your cancer, your
doctor may give you the option of stopping your participation and
starting another course of treatment. In some cases, you may enroll in
another clinical trial.

Clinical trials are safe

Patient safety is MD Anderson’s primary
concern. Clinical trials are designed by experts and go through
several rounds of approval. Before enrolling patients, a proposed
clinical trial receives its final approval from the Institutional
Review Board (IRB), a committee made up of physicians, nurses,
researchers, patients and lawyers.

Clinical trials are for patients at all stages of cancer

Although all clinical trials have criteria for the participants,
clinical trials are available to patients at all stages of cancer. The
eligibility criteria, which is meant to ensure patients’ safety, may
include the patient’s age, gender, cancer type and stage, previous
treatments and overall health.

Your doctor is the best resource for knowing your treatment options.
But don’t hesitate to ask if there are clinical trials that are
available to you. By enrolling in a clinical trial, you help us
advance cancer care by discovering more successful treatments that may
extend or save your life. You’ll create a legacy of hope for future patients.

Request an appointment at MD Anderson online or by
calling 1-877-632-6789.