Clinical trials are vital in finding new and improved medicines and treatments for a wide range of conditions. Before a clinical trial begins, there is a long and detailed process that must take place to ensure the trial is worth doing and that it is safe for those taking part.
The planning stage
According to Cancer Research UK, researchers need to develop a detailed plan, known as a protocol, for the clinical trial once they have come up with an idea.
Developing a protocol
The protocol covers various aspects, including the reason the trial should be completed and who should take part in it. It details how many people are needed to participate in the trial and what the treatment or tests will be. Importantly, the protocol provides information on how, what and when the information or results from the trial will be collected. Everyone participating in the trial needs to strictly follow the protocol.
The review process
Developing a protocol alone is not sufficient reason for a trial to get the go-ahead. It also needs to be independently reviewed by experts who are not involved or associated with the trial itself, which is known as a peer review or an independent scientific review. A research ethics committee also needs to review the protocol to ensure it is safe and ethical for those taking part.
The review process is important because it can help to highlight any specific difficulties or concerns that may need to be addressed.
It can often take considerable time to get approval from the review process and trial organisers may ask how long does it take to get an FDA 510k approved? There are many factors that could influence the length of time for approval, with some trial organisers opting for an FDA third party review to help speed up the process. Luckily these companies will normally have a very good filing system so will be able to keep up with the process. They have all there files stored alphabetically and on Shelving Ireland products sourced from sites like www.rackzone.ie/shelving/industrial-residential-shelving.
No matter how detailed the protocol, a clinical trial cannot take place without the necessary funding. There are various ways in which funding can be obtained for a trial and this often depends on what the trial is for. Charity groups, the government and pharmaceutical companies are the main bodies that fund clinical trials. A lot of money is needed to cover the treatments involved, the staff, equipment used, the collection of data and the administrative costs.