In phase 3 trials, an experimental study drug or device is used in a large group of people. Researchers then compare it to commonly used treatments, determine its effectiveness and monitor for side effects. This information will allow the drug or device to be used safely and gain full approval from the FDA, making it available to patients outside of a clinical study. Phase 4 trials, also called post-marketing studies, are conducted after a treatment is approved for use by the FDA. They can provide additional information including the intervention’s risks, benefits, best use practices, and effects from long-term use.

A sponsor can be an individual, pharmaceutical company, governmental agency, academic institution, private organization, or other organization and can initiate a study. The ROC Foundation primarily partners with medical device companies who are required to do post-market surveillance studies on their devices. Sponsors oversee the study to make sure it is compliant with regulations and review the de-identified data. They are not involved in the day-to-day research activities and data collection, which is run by the primary investigator (a ROC surgeon) and research staff (ROC Foundation staff).

Physician-initiated studies are studies started and run by physicians without the involvement of a sponsor. These studies still must follow regulations and gain approval through the local authority just as the sponsor-initiated studies do.

People may participate in studies with the goals of advancing medical knowledge and helping others. They may also participate to have access to a newer treatment.

For current active studies that are recruiting participants, if your designated physician who is also involved in research deems you a good candidate for a study (i.e., all eligibility criteria is met), the research staff will introduce and discuss the study with you. If you do decide to participate, you will sign an informed consent form. You will be officially participating in the study once the consent form has all the appropriate signatures.

Participating in clinical research greatly contributes to knowledge and improvement of medical technology and interventions. It cannot be guaranteed that the participant will receive any medical benefits from being in the study.

The ROC Foundation follows HIPAA regulations. Only authorized personnel (e.g., research staff, etc.) may access the patient’s records for only the purpose of their job.

Total joint replacements are performed in patients suffering from severe joint pain and instability due to conditions like arthritis.