Every year, researchers work with thousands of volunteers to collect new data about medications; and shortly thereafter, new treatments enter the marketplace in part, due to the impactful findings collected. Clinical trials are essential to the current U.S. drug-approval process, to establishing medication efficacy and safety, and to the future of medical innovation.
Here are a few interesting facts about clinical studies that you might not already know:
Sponsors manage and monitor clinical studies to ensure continual progress. Either an individual or an organization may sponsor a clinical trial, but this role is always critical to the study’s outcome.
Additionally, sponsors are in charge of:
An IRB determines which studies are approved for the respective clinical study phases, and also ensures the well-being of all participants throughout the clinical trial process. These researchers, doctors and members of the medical community defend the ethical rights of all study volunteers.
With volunteer safety and welfare being a top priority for Institutional Review Boards, trial protocols and research methods are closely examined to prevent any unnecessary risks or dangers.
Post-market surveillance examines the long-term safety and effectiveness of new medications and seeks to expose any previously unidentified side-effects. The Federal Drug Administration (FDA) explains, “These activities are designed to generate information to quickly identify poorly performing devices and other safety problems, accurately characterize real-world device performance and clinical outcomes, and facilitate the development of new devices, or new uses for existing devices.”
With regard to medical devices, the FDA also keeps a watchful eye on tracking, device malfunctions, injuries or deaths and product registrations.
In addition to certain private organizations, the federal government provides clinical trial funding. Clinical research facilities have differing policies, and it is important to carefully review volunteer compensation and reimbursement policies prior to enrolling and participating in a clinical study.
At OCRC, all study participants receive study treatments and medical care related to the trial. Additionally, participants may be compensated for time and travel. Health insurance is never a requirement.
Clinical researchers work in many different locations, across all 50 states, to advance medical knowledge and to improve the health and wellbeing of the general population. Clinical studies are performed at hospitals, medical clinics and at cancer centers. This is often the case because of the innovative therapies available at cancer centers.
Researchers are currently looking for volunteers with diverse backgrounds, ages, ethnicities and health conditions to enroll in current clinical studies. Learn more at clinicaltrials.gov.