Guidelines

What is OPC clinical trial?

What is OPC clinical trial?

In certain device areas, sponsors work with the FDA to examine outcomes of patients treated with similar devices and create objective performance criteria (OPC). Patients receive the novel device in a one-arm trial, and their outcomes are compared to the OPC.

How much do clinical studies pay?

Clinical trials generally pay between $50-$300 per day/visit, with compensation dependant upon the length of the time required as well as the procedures performed. Overnight stays typically pay more money than those involving repeat visits.

Which are the two main types of clinical studies?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies.

What do clinical studies do?

Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people.

Are there any health benefits to taking OPC?

Several human clinical trials were done recently on relatively small number of participants, and the results support the health benefits of OPCs as a dietary supplement. Several more human clinical trials using OPCs as grape seed and pine bark extracts are in progress.

Which is the best OPC extract to take?

Several more human clinical trials using OPCs as grape seed and pine bark extracts are in progress. The OPC antioxidant activity of grape seed and pine bark extract is well established. The biological studies have also revealed a variety of other activities for OPCs.

When was OPC first used for medical devices?

OPC have been used for regulatory approvals in very few device areas, and creating or updating OPC requires considerable time and effort. The FDA first considered an OPC in approving a surgical heart valve in 1997. Thanks to the long track record of valve performance, heart valves were an obvious device area in which to develop OPC.

Which is the best OPC supplement for high cholesterol?

All the results indicate that grape seed extract OPC is the super antioxidant, an excellent dietary supplement for people of high blood pressure and high cholesterol.