A clinical research study, also known as a Clinical Trial, is a carefully designed study in which participants (patients) are asked to take an investigational medicine under the supervision of a doctor and other research professionals.
Patients volunteer to participate in a Clinical Trial, which are conducted and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. Some people participate in clinical trials because none of the approved treatment options have worked, or they are unable to tolerate certain side effects. Clinical trials provide another option when standard therapy has failed. Others participate in trials because they want to contribute to the advancement of medical treatments. There are several phases of approval in the clinical trials process before a drug or device can be sold in the consumer market, if ever, please refer to the graphic.
All clinical trials have guidelines called “eligibility criteria” about who can participate. The criteria are based on factors such as age, sex, type and stage of disease, previous treatment history, and other medical conditions. Therefore, not everyone who applies for a clinical trial will be accepted. If you are interested in taking part in a clinical trial, you are invited to call 813-240-9734 to speak with one of our research specialists to discuss your options and have your questions answered. You can also contact us here to see how you can be a part of the efforts to identify breakthrough treatments for those in need.
Before you participate in a clinical trial, a detailed description of the research study, as well as possible risks and benefits, will be provided in writing in an “informed consent document” and discussed with you. You will be asked to review and sign the informed consent document prior to participating. Your medical history will be reviewed, and you will be given a study-required medical exam and study-required laboratory tests. If you qualify, you may be enrolled in the study. Once enrolled, feel free to discuss your research care with the study doctor or research site staff at any time during the study.
- Attend all scheduled visits
- Describe your feelings and well-being accurately and honestly to the study doctor
- Use the investigational medicine as directed
- Discuss any questions regarding the study with the study doctor or research personnel
- As a study participant, you are not obligated to remain in the study and can withdraw at any time.
Patients who participate in a clinical trial have access to treatment for specific ailments before they are available to the public and at no monetary cost to them. No medical insurance is needed. Patients with newly diagnosed medical problems of all ages are welcome to participate in studies about their disease or medications related to their disease if they meet the criteria for the study. Volunteers can also take pride in knowing that their participation is furthering the process of finding new medicine and methods of treatment for diseases, and ultimately help make scientific breakthroughs.
Patients who decide to volunteer in a clinical trial are compensated for their participation and travel expenses while taking part in the study.
GCP Clinical Research advocates for its patients to ensure safety, protection and confidentiality for all patients participating in our clinical trials. These include the Patient Bill of Rights and Hospital Accreditation to ensure that an international review board must approve every new study at a hospital or medical facility before it can begin. Our bilingual staff meets with each patient to present all the facts and details about the clinical trial and explain the informed consent process before deciding to participate. At GCP, you never have to wait when you arrive for your study visits and you can feel reassured that our Patient Support throughout your participation in the study is Continuous.