Participating in Clinical Trials
Participating in clinical research at Bascom Palmer can benefit individuals in several ways. A clinical trial may provide access to new and experimental treatments that may not be available through standard medical care. Participating in research can help advance medical knowledge and improve the understanding and treatment of eye diseases. However, it's important to understand the risks and benefits of participating in a clinical trial and to consult with a doctor before making a decision. Participating can also help people with a specific eye condition connect with other individuals affected by the same condition. Additionally, clinical trial can also provide a sense of hope and empowerment to participants that they are contributing to the betterment of the eye health care.
Clinical Trial Interventions
Clinical trials are conducted in a controlled and systematic manner to test specific interventions according to the research plan or protocol. These interventions may be medical products, such as drugs, devices, procedures, or lifestyle changes. 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.
Phases of Clinical Trials
Clinical trials used in drug development are sometimes described by phase. These phases are defined by the Food and Drug Administration (FDA):
Exploratory study involving very limited human exposure to the drug, with the goal of collecting information to move into Phase 1.
Studies conducted in a limited number of subjects to determine drug safety. The goal is to find out what the drug's most frequent and serious adverse events are and may involve studying how the drug is metabolized and excreted.
Studies that gather preliminary data on effectiveness in a small group of subjects who have a certain disease or condition to gather more information to determine how best to test the effectiveness of the treatment further in a phase 3 study. For example, participants receiving the drug may be compared to similar participants receiving a different dose of the drug or a different treatment or an inactive substance, called a placebo. Safety and short-term adverse events continues to be evaluated.
Studies that tests a large group of subjects to determine if the treatment has significant effectiveness with acceptable risk to be approved by the FDA. participants receiving the drug may be compared to similar participants receiving a different dose of the drug or a different treatment or an inactive substance, called a placebo.
Studies occurring after FDA has approved a drug for marketing. These including postmarket requirement and commitment studies that are required or initiated by the study sponsor. These studies gather additional long-term information about a drug's safety, efficacy, or optimal use.