The National Institute of Health define Clinical trials as “research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. Clinical trials are one of the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ideas”. A clinical trial is a research study conducted in human volunteers.
Each clinical trial has a master plan called a protocol. This plan explains how the trial will work. The trial is led by a principal investigator (PI), who often is a doctor. The PI prepares the protocol for the clinical trial.
The protocol outlines what will be done during the clinical trial and why. Each medical center that does the study uses the same protocol.
Key information in a protocol includes
Clinical trials are a key research tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don’t knowwhether a new approach works well in people and is safe and which treatments or strategies work best for certain illnesses or groups of people.
Taking part in a clinical trial can have many benefits. For example, you may gain access to new treatments before they’re widely available. If a new treatment is proven to work and you’re in the group getting it, you might be among the first to benefit. If you’re in a clinical trial and don’t get the new strategy being tested, you may receive the current standard care for your condition. This treatment might be as good as, or better than, the new approach. You also will have the support of a team of health care providers, who will likely monitor your health closely.
All clinical trials have guidelines about who can participate. These guidelines help to produce reliable results. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in that clinical trial, while others need healthy participants.
Clinical trials are conducted in different “phases”. The trials at each phase have a different purpose and help scientists answer different questions. Generally, clinical trials go through 4 phases of studies.
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. Before your participation in a clinical trial begins, the study doctor and the Renal Medicine Research staff will explain the details of the study. These details are contained in an “informed consent form”.
Physician investigators who conduct research at Renal Medicine Associates are required to have fulfilled training and certification in the principles of protection of human subjects and in the conduct of clinical research to the highest ethical and moral standards (known as GCP or Good Clinical Practice). This includes having completed training in issues related to potential financial conflicts of interest.