Understanding STOH Clinical Trials at The START Center

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For more information about Clinical Research Trials, please contact:

Lacey Frank, RN BSN, CRCDirector of STOH Clinical ResearchThe START Center for Cancer Care

4383 Medical Drive, Suite 4032San Antonio, TX 78229

Phone (210) 593-5725 • Fax (210) 593-2664lacey.frank@stoh.com

Locations:Research Locations1. The START Center 210-593-5700 4383 Medical Drive San Antonio, TX 78229

2. Downtown 210-593-5200 Santa Rosa Pavilion 315 N. San Saba, Ste 1160 San Antonio, TX 78207

3. Sonterra 210-593-2503 155 E. Sonterra, Ste 200 San Antonio, TX 78258

4. North Central Radiation Center 210-593-5800 The Atrium at NC Baptist 502 Madison Oak Ste 120 and 160 San Antonio, TX 78258

5. Northeast 210-593-5600 Northeast Baptist MOB 8715 Village Drive, Ste 116 San Antonio, TX 78217

6. Boerne 210-593-5900 134 Menger Springs Rd. Ste 1120 Boerne, TX 78006

7. Bandera 210-593-5700 1300 Cedar Street Bandera, TX 78003

8. Westover Hills 210-593-5700 11212 Hwy 151, Ste 250 San Antonio, TX 78251

What is a clinical trial? A clinical trial is a research study that involves patient volunteers, or participants, in order to answer a specific health question and also help find potentially better ways to prevent, diagnose or treat cancer. Clinical trials help doctors and researchers gain information on the benefits, side effects and potential new uses of certain drugs. Some trials have experimental drugs while others use standard drugs in new ways that are safe and effective.

Who can participate in a clinical trial?All clinical trials have guidelines about who can participate. Before joining a clinical trial, you must qualify for the study. Certain factors that allow someone to

participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria.” These criteria are based on such factors as

age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.The research team will check the health of the participant at the beginning of the trial, give specific instructions for participating in the trials, monitor the participants carefully during the trial, and stay in touch after the trial is completed.

What is informed consent?Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. To help someone decide whether or not to participate, the doctor involved in the trial explains the details of the study. Then the research team provides an informed consent document that includes details about the study. Risks and potential benefits are explained in the informed consent document.

The participant may take the consent home to read and decide whether or not to sign the document. If the participant decides to join the clinical trial, they will be

asked to sign the consent document; by doing so, this shows they understand what you have read and all their questions have been answered. The informed consent is not a contract, and the participant may withdraw from the trial at any time.

Every clinical trial in the United States must be approved and monitored by an Institution Review Board (IRB) to make sure the risks to participants are as low as possible and are worth any future benefits. An IRB is a group of physicians, statisticians, community workers, and others that ensure that a clinical trial is fair and the rights of the study participants are protected. Every informed consent is reviewed and approved by the IRB.

What kind of preparation should a potential participant make for the meeting with the doctor or research coordinator?• Plan ahead and write down possible questions to ask• Ask a friend or relative to come along for support and to

hear the responses to the questions.

What should people consider before participating in a trial?People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team.

Some of the answers to these questions are found in the informed consent document.• What is the purpose of the study?• Who will be in the study?• Why do researchers believe the new treatment being

tested may be effective? Has it been tested before?• What kinds of tests and treatments are involved?• How do the possible risks, side effects, and benefits in

the study compare with my current treatment?• How will this trial affect my daily life?

• How long will the trial last?• Will hospitalization be required?• Who will pay for the treatment?• Will I be reimbursed for other expenses?

• What type of long-term follow-up care is part of this study?

• How will I know that the treatment is working?• Will results of the trials be provided to me?• Who will be in charge of my care?• Will I have any additional costs if I choose to

participate in this study?• What will happen if I do not choose to

participate in this study?

Why should I participate?Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

The START Center for Cancer Care4383 Medical Drive, Suite 4032

San Antonio, TX 78229www.TheStartCenter.com