Frequently Asked Questions About Clinical Trials


Q: What are clinical trials and why are they important?

A: When a drug company wants to license a new drug, the United States Food and Drug Administration (FDA) requires that the drug be tested in a large number of patients to make sure that the drug is both safe and effective. The company must then select a number of medical research centers or clinics around the country that can recruit qualified patients for the study.

Sometimes, the studies involve drugs that have already been approved by the FDA, but the drug company is trying to show that the drug is effective for another illness. With any new treatment, there may be risks, as well as possible benefits. These studies usually involve several visits to the clinic. Research participants are often asked to keep diaries of their symptoms and medication use. In many cases, participants may also be eligible for reimbursement.

Clinical trials must take place before new research treatments can be made available to the public for prescription or over-the-counter use. Many currently available medical treatments have been analyzed through clinical trials, which are carefully monitored under strict government regulations.

Clinical trials are important to ensure that individuals receive safe and effective treatments for their health conditions, from heart disease to headaches. They provide the means to develop new treatments that are as effective, more effective or safer than treatments already on the market; they enable researchers to discover new therapeutic uses for currently available medications; and they make it possible to develop innovative treatments for conditions that currently have no treatment.

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Q: Who runs clinical trials?

A: Most clinical trials are sponsored by pharmaceutical companies, federal health agencies, medical foundations, medical centers and universities; however, physicians may sponsor some clinical trials, particularly when the trial evaluates a currently available treatment for a condition other than for what it was previously approved.

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Q: Where do clinical trials happen?

A: Clinical trials are performed around the world in various settings, including doctors' offices, hospitals, research centers and teaching institutions such as universities. Since most trials require periodic visits to the study physician, volunteers should take the location of the facility into consideration when deciding whether or not to participate in a clinical trial.  Our facility is located at:

Worldwide Clinical Trials Drug Development Solutions Clinical Research Services
2455 Northeast Loop 410, Suite 150
San Antonio, TX 78217
Tel: +1 210 635 1500
Fax: +1 210 635 1646

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Q: Why should I participate in a clinical trial?

A: People participate in clinical trials for various reasons, including health, financial and personal needs. Volunteers who participate in clinical trials help to further advance medical science, which may help others in the future. While there are no guarantees that participants will benefit from the research treatment they receive, some may find that the study medication relieves their condition more effectively and/or with fewer side effects than their previous treatment plan. Clinical trials sponsored by pharmaceutical companies often provide free study medication and study-related care. In addition, financial compensation for time and travel expenses may be provided to study participants in some clinical trials.

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Q: Are there risks to being in a clinical trial?

A: There are risks to participating in a clinical trial. Although every effort has been made to determine the risks during preclinical and early clinical studies, there may be side effects and other health risks that are as of yet unknown. Side effects differ from one person to another, and there is no way to predict how the treatment will affect any given individual. Some of the risks are that participants may not receive active treatment for their condition and/or the study treatment may not be effective. Trials sometimes require washout periods when subjects have to go off all active treatments for a period of time. The reasonably foreseeable risks of a study are listed in the informed consent form.

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Q: What is a placebo?

A: A placebo is an inactive substance that may be given to a percentage of the study participants in a clinical trial to assist in comparing the effects of the active study treatment.

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Q: What is informed consent?

A: Informed consent is the process by which a potential study participant is provided with information about the study and treatment before deciding whether or not to participate in the trial. It includes an explanation of what is involved in the trial, the duration of the study, the frequency and length of the required visits, as well as the known risks and benefits associated with the study treatment.

Participation in a clinical trial is completely voluntary. All questions about the study should be answered to the patient's satisfaction before an informed consent form (ICF) is signed. Patients have the right to refuse participation or to withdraw their consent at any time during the study without penalty.

The wishes and best interest of the patient are considered at all times and, throughout the trial, participants will be provided with any new information that may affect their decision to continue their participation in the study. In addition, the study physician may withdraw a patient at any time, without the patient's consent, if it becomes evident that it is not in the patient's best interest to continue participation.

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Q: What are my responsibilities as a participant in a clinical trial?

A: In the interest of safety, the participant must fully inform the study physician about past and current medical conditions, illnesses and medications, follow the prescribed treatment plan, and attend the scheduled visits. Other study-specific responsibilities will be explained by study personnel.

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Q: Do I have to pay to be in a clinical trial?

A: There is no cost for joining a clinical trial, and study medication as well as study-related tests and procedures are usually provided at no charge to study participants. It is important to ask the research staff to explain exactly what charges, if any, may be the responsibility of the study participant. Tests and procedures that are part of a patient's routine health care may or may not be covered by the patient's health insurance plan. In some cases, you may be compensated for your time and travel expenses related to study participation.

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Study Information Hotlines: 512 345 0032 (Austin) 210 635 1515 (San Antonio) 800 580 2184 (Toll Free)


If you have any comments, questions or concerns about your current or previous study participation, please contact the Subject Advocate at subject.advocate@wwctrials.com