Clinical Research FAQ - High Point Clinical Trial Center
 

Clinical Research FAQ

WHAT IS A CLINICAL STUDY?

According to ClinicalTrials.gov, “in a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants’ behavior, such as diet.

 

Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention).

 

The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases.

 

Clinical trials used in drug development are sometimes described by phase. These phases are defined by the Food and Drug Administration (FDA).”

  • PHASE 0

    Exploratory study involving very limited human exposure to the drug, with no therapeutic or diagnostic goals (for example, screening studies, microdose studies)

  • PHASE 1

    Studies that are usually conducted with healthy volunteers and that emphasize safety. The goal is to find out what the drug's most frequent and serious adverse events are and, often, how the drug is metabolized and excreted.

  • PHASE 2

    Studies that gather preliminary data on whether the drug works in people who have a certain disease or condition. For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance, called a placebo, or a different drug.

  • PHASE 3

    Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

  • PHASE 4

    Studies occurring after FDA has approved a drug for marketing. These including postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These studies gather additional information about a drug's safety, efficacy, or optimal use.

FACT OR FICTION?

Participating in a clinical trial can be a big decision. Should you do it? What does it mean? To give you an idea of what this encompasses, our studies involve the administration of investigational treatments to subjects by a physician and other medical professionals. These treatments are developed by pharmaceutical and biotechnology companies who select qualified physicians, also known as investigators, to conduct clinical trials to determine the characteristics of investigational drugs.
  • CLINICAL TRIALS

  • The government funds some clinical trials and the private sector, including biopharma companies, fund others. They are referred to as the Sponsor of the study and may hire physicians, who work in a variety of health-care settings, to conduct the clinical trial. These physicians provide medical care for free to the patient. Additionally, the patient is eligible for a fee to participate in a trial.

  • STUDY SUBJECTS

  • Subjects participate in clinical research for their own reasons. Sometimes this includes medical attention they may not have access to otherwise. The medical care allows access to medications not yet commercially available. The expectation with this medical care is you as the participant commit to completing the clinical trial so the drug under study can be analyzed for the benefit of future potential patients.

  • RESEARCH CENTER

  • The research center also has responsibilities the volunteer as well as the Sponsor. Approval for the study is granted to the site and physicians by an Institutional Review Board, which is typically composed of physicians and people from the community. This group evaluates the study to guarantee that the subjects’ rights are protected and that there are no  undue or unnecessary risks.

  • PAPERS & FORMS

  • The volunteer receives full disclosure of the protocol expectations, activities and risks inherent in the study in a document called the Informed Consent Form (ICF). The best volunteer experience comes to patients when they have discussed participation with their medical caregivers, including their physicians, and when they understand the setting and personnel they will be working with during the study conduct.