Common reasons for conducting clinical trials include:
-Evaluating the safety and efficacy of one or more interventions (such as medications or medical devices) for treating a disease, syndrome or condition.
-Finding ways to prevent the initial development or recurrence of a disease or condition; through means such as medicines, vaccines, or lifestyle changes.
-Examining methods of identifying (or diagnosing) a condition or the risk factors for that condition.
Every clinical trial is led by a principal investigator who is most often a medical doctor (MD). Clinical trials also have a research team that may include doctors, nurses, clinical research coordinators, social workers and other health care professionals. Clinical trials can be sponsored or funded by pharmaceutical companies, academic medical centers, voluntary groups, health care providers or other organizations.
"The staff is wonderful. You couldn't ass 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." - Jim
There are many benefits to participating in a clinical trial. Participants in a trial receive care tailored to their diagnosis, including potentially better treatment options compared with the current standard of care. Participants will receive close monitoring from our excellent physician investigators as well as study-related exams and tests, blood work, the study medication, and monetary compensation for time and travel (amount varies per study). Participants also allow others to benefit by contributing to the advancement of medical knowledge and innovation.
"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." - Margaret
"Outstanding compassionate and caring researchers doing vital work to further the medical sciences. Highly recommend taking part in the studies they conduct!" - Gerry
"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."
The "informed consent" document provides potential and enrolled participants with information about the clinical study they will participate in at the very first visit. The informed consent is intended to protect participants and should provide the participant with information to help understand the benefits, potential risks, and alternatives to the study. The research coordinator will explain and discuss the informed consent with the participant. Signing an informed consent is not a binding contract and participants may withdraw from a study at any time even if the study has not been closed.
Each federally supported and conducted clinical medication, biological product or medical device trial is regulated by the FDA and 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. The IRB will supervise the study and ensure the ethical rights and welfare of participants are protected. This includes making sure that all research risks are minimized and are reasonable in relation to any potential benefits.
Clinical trials have criteria which outline who can participate. In many studies, researchers seek participants who are diagnosed with the illness or condition that is to be studied, while others seek healthy participants. Some studies are limited to a predetermined group of people who are directly asked by researchers to enroll based on a specific set of criteria. The factors that allow someone to participate in a clinical trial are called inclusion criteria and the factors that disqualify one from participating are called exclusion criteria. These criteria are often based on age, sex, presence of the medical diagnosis to be studied, previous treatment history and the type and stage of the illness, among others.