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"I love my coordinator! She is very concerned about my medical condition. She makes me feel very comfortable with the trial. The study has brought up some other medical issues I would not have otherwise been aware of. Also, doing the study has helped me financially as the medication and supplies are covered.
"I have been very pleased with the staff at PCR! They have been great, comfortable, and caring. That has made all the difference. Having someone to see me so often, has made managing my diagnosis easier."
"The staff is wonderful. You couldn't ask for better people to help you with your medical conditions. The world needs more doctors like Dr. Grossman. I so enjoy working with my coordinator. She is very good at what she does and always lifts my spirits. I like that I am doing something that can help other people. If what I am doing helps even one person, then volunteering for the study was worth it!
"I have nothing but great things to say about PCR! I enjoy spending time with the staff and I really feel like my medication is helping my symptoms."
There are a multitude of benefits to participating in clinical trials for both the individual and for the medical community as a whole. Benefits for the individual volunteer include being able to focus on a particular diagnosis, have access to potentially better treatment options that are not yet available to the public, and being able to partner closely with our clinical coordinators and physicians. Also, if you qualify, no insurance is needed and compensation may be available. By participating in a clinical trial, volunteers are also playing a critical long-term role of helping future patients.
Informed consent is a process in which researchers provide potential and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll or continue to participate in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. Signing an informed consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over.
Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by the FDA must be reviewed, approved, and monitored by an Institutional Review Board (IRB). An IRB is made up of physicians, researchers, and members of the community. Its role is to make sure that the study is eithical and that the rights and welfare of participants is protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits.
Clinical studies have standards outlining who can participate. Some research studies seek participants who have the illnesses or conditions that will be studies, other studies are looking for healthy participants, and some studies are limited to a predetermined group of people who are asked by researchers to enroll. The factors that allow someone to participate in a clinical study are called inclusion criteria and the factors that disqualify someone from participating are called exclusion criteria. These are based on things such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
In general, clinical studies are designed to add to medical knowledge related to the treatment, diagnosis, and prevention of disease or conditions. Some common reasons for conducting clinical studies include:
Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals. Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups, physicians, health care providers, and other organizations.