Standard Clinical Trial Operating Procedures

Clinical trials are research studies done to evaluate new treatments in people. Clinical trials ensure that new medicines and procedures are safe and effective before they are available to the general public. According to the National Library of Medicine (NLM), clinical trials are performed after thorough laboratory research and after scientists have sufficient evidence to believe a new treatment is as good as or better than currently available treatments. "Carefully conducted clinical trials are the fastest way to find new treatments that work in people," says the NLM.

Preparing For a Clinical Trial

• A clinical trial is designed to answer a specific set of research questions. The doctors and scientists conducting the trial follow a plan called a protocol, which details exactly what will be done and why. Studies are designed to safeguard the safety and health of the participants as well as answer the study questions. According to the NLM, ethical and legal guidelines that govern medical practice apply to clinical trials. Furthermore, most clinical trials are federally regulated with built-in safeguards. The research institution conducting the research reviews the trial for patient safety and scientific merit.

Study Participants and Informed Consent

• Clinical trials are conducted using volunteers. Researchers conducting the study ensure participants are similar in certain ways, such as the nature or stage of their particular illness. Before the study is begun, doctors and researchers conducting the study explain the details of the study and provide informed consent forms for the participants to carefully read and sign if they choose to participate in the study. Researchers will continually update participants on information that may affect their willingness to participate in the study and volunteers may leave the study at any time.

Control Group and Study Group

• Participants are randomly divided into groups. One group, called the "control group," will receive the current treatment for their disease, while the second group, the "study group," will receive the new treatment being evaluated. Both the control group and the study group will be followed carefully throughout the study. In cases where there is no current treatment for a disease, the control group will receive no treatment. In other instances, two or more treatments may be evaluated by the same study. If there is conclusive evidence one treatment is better than the other, the trial is stopped and participants are offered the benefit of the new treatment.

Reporting Results

• Throughout the trial, data is collected and reported in medical journals and scientific meetings as well as to various government agencies. However, individual names are not released with the data and participant privacy is protected.