We welcome the opportunity to speak with you about current and upcoming studies.
What is a Clinical Study?:
A Clinical Study is carefully designed to test the effects of a medication, medical treatment or device on a group of volunteers. Clinical Studies are an important step in making new medications available. They measure the drug's ability to treat a condition, its safety and its possible side effects.
How is a drug approved for testing?:
The US Food and Drug Administration (FDA) typically must authorize a drug company's proposal to conduct clinical studies. Drug companies must do years of laboratory research before they can begin testing medicines in humans.
People with the condition being studied as well as healthy people can volunteer to participate in a study. The FDA has very strict requirements that specify which studies involve healthy volunteer and which studies involve patients with the condition being studied.
Each study has specific requirements such as age, sex, or medical condition for participants. The physician conducting the study will review each volunteer's medical history and the study requirements to determine who can participate. Known risks and discomforts will be explained by the study physician prior to participating in the study. In addition to the known risks, there may be unknown risks such as medication side effects involved in participating in a clinical study. Study procedures, risks, and benefits are explained to volunteers during the informed consent process.
Informed consent is the process designed to give volunteers the information that they need to decide about participating in a clinical study. This process allows the volunteer to ask questions and exchange information freely with the clinical team. The clinical investigator is responsible for ensuring that informed consent is obtained from each research volunteer before that person participates in the research study.
The IRB is a group of healthcare professionals and non-scientific members which must review and approve a clinical study prior to it beginning. The IRB carefully reviews study activities because its primary responsibilty is to protect the safety and rights of study participants.
Med Investigations is conducting many research studies, and are always looking for volunteers to participate.
For more information on clinical studies and how to become a volunteer, please complete the patient interest form.
Volunteering to participate in a clinical drug study is one way you can contribute to the understanding of diseases that affect people and the development of new therapies. Volunteers are important to the clincal study phase in the drug approval process. As a volunteer, you are an important link in a long chain of research and testing in the development of new medications for a broad range of health problems.
Each year thousands of people volunteer to participate in clinical drug studies. Benefits to you as a volunteer may include:
* Participating in a research process which may lead to new therapies.
* Receiving medical care from physicians during the study.
* Learning new information about your condition, and receiving information that you can share with your personal physician.
