Clinical trial monitoring is oversight performed to ensure the health and safety of patients participating in clinical trials of new drugs, treatments, or vaccines. It is typically led by a clinical research associate. Clinical trials are carried out after laboratory testing of a drug, vaccine, or therapy has shown that it is safe for human use. Before a drug can be released to the general public, trials are conducted to see if it is effective in humans and to note any adverse reactions experienced by participants.
Monitoring entails gathering and analyzing data from the start of a trial to the end to ensure that the methodology and results are accurate. Clinical trials follow a protocol that specifies what the researchers will look into and do throughout the study. The clinical research associate is usually responsible to an institutional review board, which is formed when a clinical trial is launched and evaluates the trial’s progress and outcomes on a regular basis. Clinical trial monitors check to see if trials are being carried out in accordance with local, national, and international laws and best practices.
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH TR) recommends that clinical trial monitoring follow GCP guidelines (ICH). This group brings together regulators from Europe, Japan, and the United States to develop global guidelines to improve clinical trial monitoring safety. Government agencies that approve pharmaceutical products for sale and use, such as the Food and Drug Administration (FDA) in the United States, frequently require clinical trial monitoring. Government agencies, hospitals, universities, clinics, pharmaceutical companies, and biotechnology companies may all sponsor clinical trials.
The standard operating procedures for monitoring a trial will be determined by the trial’s sponsor. The sponsor also chooses who will oversee the trial and how many monitors will be present. The number of participants, the disease or condition being studied, and the complexity and risk of the drug or treatment may all influence how frequently and for how long the clinical research associate visits the study site. All activities that take place during a clinical trial monitoring visit are planned by the clinical research associate. After each visit, he or she usually writes a report.
The Food and Drug Administration’s Center for Drug Evaluation and Research publishes an annual list of the most common clinical trial failures. The Office for Human Research Protections is a division of the US Department of Health and Human Services that oversees clinical trials (OHRP). The OHRP provides educational resources and conferences for researchers in addition to regulation and compliance.