|
 |
| Information about Clinical Trials |
 What is a pharmaceutical research study?
What are the benefits of participating in a research study?
What are the risks involved in research study?
Why do people become involved in research studies?
What is a pharmaceutical research study?
A pharmaceutical research study is a scientific evaluation of an investigational product conducted to determine if it is a safe and effective treatment option. Pharmaceutical and biotechnical companies spend years analyzing investigational compounds in the laboratory. Once the pharmaceutical research company identifies a compound that they feel will be an effective medication, a protocol is devised to test the product. The U.S. Food and Drug Administration and Institutional Review Boards review protocols to determine if they are safe and ethical, prior to any testing on humans. There are four phases of clinical trials, ranging from testing the compound on a small number of healthy adult volunteers to studies that encompass thousands of patients and involve a comparison of the investigational drug to placebo (inactive substance) and other, approved, treatment options. If the data collected during the research studies proves the drug to be a safe and effective treatment option, the FDA then approves it as a new prescription medication.
Top
|
| Studies can last for weeks, months or even years, during which time patients can save the enormous cost associated with paying for medications and office visits. |
|
What are the benefits of participating in a research study?
Patients in research studies receive study-medication, tests and exams at no charge throughout the course of the study. Studies can last for weeks, months or even years, during which time patients can save the enormous cost associated with paying for medications and office visits. Study coordinators and physicians closely monitor the study patients, and perform physical exams, laboratory tests and other medical procedures to collect information on the patient. Often, these procedures are described as an extension of what is traditionally conducted to manage the patient’s health and medical condition.
In addition to the medical and health-associated benefits, patients in research studies have the unique opportunity to contribute to the advancement of medical research. Your participation in a research study can affect and improve the treatment of medical conditions for generations to come.
Top
What are the risks involved in research study?
Exposure to an investigational product is associated with some risk. Your body may respond in an unexpected way to the investigational product, you may not receive the intended benefit, or you may experience unexpected or unwanted side effects. However, both the U.S. Food and Drug Administration and the Institutional Review Boards monitor research studies closely. Studies that are deemed unsafe or unethical by the Institutional Review Board are not conducted. Your study coordinator and physician also closely monitor your health status and response to the study drug throughout study participation. At your first study visit all of the risks and benefits are outlined in a very detailed document called the Informed Consent Form. This form is reviewed and the study patients can discuss any questions with the study coordinator and doctor prior to any study procedures being conducted.
Top
|
| Patients come to appreciate the close medical care they receive in a research study and enjoy attending the study visits at the research center.
|
|
Why do people become involved in research studies?
People like you participate in research studies for many different reasons. Often they are seeking alternatives to the current treatment options available for their medical conditions. Participants in research studies have access to medications long before they’re available to the public.
Many research patients take part in studies due to relationships they’ve built with study coordinators and physicians over years of study participation. Patients come to appreciate the close medical care they receive in a research study and enjoy attending the study visits at the research center.
Research studies also include volunteers who want to advance the medical research process. Patients often feel frustrated and helpless to contribute to their current treatment options. Through participation in a research study their opinions help shape medical options for years to come.
Top
|
|
