Frequently Asked Questions:
We recommend you review all the questions on this page if you are interested in becoming a research subject.
Please click on each question for the answer:
• Why Do Clinical Research Studies Exist?
• What Happens In A Clinical Research Study?
• What Are The Benefits Of Participating in A Clinical Research?
• How Do I Find Out If I Qualify for A Clinical Research Study?
• How Safe Are Clinical Research Studies?
• What Are Placebos And Why Are They Used?
• What Must I Understand Before Becoming A Research Subject For A Clinical Research Study?
• Why Should I Choose Diagnostics Research Group For My Study Participation?
Why Do Clinical Research Studies Exist?
• To evaluate the safety and effectiveness of new drugs, new combinations of drugs, treatments, and medical devices.
• They may also evaluate new uses for drugs that are already on the market, as well as evaluate and develop new treatments for medical conditions that may currently have no successful treatment available.
• Before the U.S. Food and Drug Administration (FDA) will consider approving new treatments and drugs, they must be proven to be safe and effective in treating a disease or illness.
What Happens In A Clinical Research Study?
Each research study is designed as a test for a specific device, treatment, or medication. The length of your participation in a clinical research study can vary from a period of weeks to several years.
• Subjects (you) express interest in becoming study participants.
• You are asked to read, and then sign the Informed Consent. The Informed Consent provides you with the full details necessary for you to make an informed decision about becoming a research study participant in that trial.
We ask that you not sign the Informed Consent document until all your questions have been answered.
• You will enter a thorough screening process to see if you qualify as a participant. The screening process consists of collecting information about you. This information is collected through screening procedures such as medical and surgical histories, medication histories, physical measurements such as blood pressure, heart rate, weight, blood testing, skin testing, EKG's, X-Rays, pulmonary function testing, etc. Each study determines which particular screening procedures will be performed.
• As a subject in one of our studies, you will be made comfortable and treated respectfully by our professional research staff.
• As a study subject you may be required to complete questionnaires and symptom diaries, and record all medications you take while in the study. Some studies require some of the following procedures to be performed: blood collection, urine and other specimen collection, pulmonary function testing, electrocardiograms and X-Rays.
• At the close of the trial, data collected from study participants is presented by the company Sponsor to the FDA. That agency then makes a decision to approve or reject the findings of the study. Only with their approval, will the new device, treatment, or medication be made available to the general public.
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What Are The Benefits of Participating in a Clinical Research Study?
• All medical evaluation and treatment related to the research study are provided to you at no charge.
• A research-trained physician will oversee your care in the area being studied.
• You will have the opportunity to receive and evaluate new treatments for your health concern.
• Your participation will help make new devices, treatments, or medications available to the general public.
• Our clinical research studies provide you with compensation for your time and travel.
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How Do I Find Out If I Qualify for A Clinical Research Study?
Each clinical research study has a distinct set of guidelines and requirements for participants. Such things as age, condition being researched, medical history, and present medical condition are all considered. Remember, you can participate in a clinical research study only if you meet the specific criteria required for that study. The FDA also specifies that you can participate in only one clinical research study at a time.
Let us know if you are interested by:
• Contacting us at 210-692-7157
OR
• Click here to go to our electronic "Contact Form”
One of our research-trained staff will then contact you and perform a preliminary screening over the phone. If you qualify on the basis of this initial screening, we will make an appointment convenient for you for a full screening visit at our research center. If you do not qualify for a specific study, you are welcome to join our database to be called for future studies.
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How Safe Are Clinical Research Studies?
• Clinical research studies are very highly controlled to ensure the utmost safety for the participants and are conducted under the direction of a pharmaceutical company that is responsible to and under the authority of the U.S. Food and Drug Administration (FDA).
• The federal government requires specific laboratory research and other designated studies to be performed on any devices, treatments, or medications prior to them being tested on human subjects.
• All clinical research studies are conducted under the close supervision of experienced research physicians. They generally take place in medical offices, hospitals, certain accredited universities and research dedicated centers such as ours.
• Another important safety requirement is that all research facilities conducting clinical research studies involving people must, by federal regulation, involve an Institutional Review Board (IRB) that approves and reviews the research to ensure compliance and safety standards.
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What Are Placebos and Why Are They Used?
• A placebo is a non-active device, treatment, or medication. It is commonly known as a "sugar pill."
• Placebos serve as a standard by which researchers test the efficacy of a device, treatment or medication.
• Placebos are not utilized in all trials. We will inform you if a placebo is used in a specific trial.
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What Must I Understand Before Becoming A Research Subject For A Clinical Research Study?
Topics that you should clearly understand before participating in a clinical research study include:
• The purpose of the research being done.
• The type or phase of the clinical research study.
• Medications or treatments that will be given during the clinical research study.
• Evaluations that will be performed during the clinical research study (laboratory, X-Rays, questionnaires, etc).
• What you are expected to do during the clinical research study.
• How long your participation will last.
• The location of the study site and how often you must come to the study center.
• Whether an overnight stay at a clinic or hospital is required.
• What a placebo is and whether or not one will be used in the clinical research study.
• Benefits you might expect from the trial.
• Your right to discontinue your participation in the clinical research study.
• Any effect on your health insurance.
• How the privacy of your health information is protected.
• Whether continuing treatment is available after the clinical research study ends.
• Who is sponsoring (paying for) the clinical research study.
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Why Should I choose Diagnostics Research Group for my study participation?
• Expertly trained professional staff.
• Fun, friendly atmosphere.
• Focus on patient comfort and safety.
• Flexible scheduling.
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San Antonio,
Texas
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