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  • Writer's pictureDr. Christine Senn, PhD

A Primer to the Clinical Research Industry

Part II of our introduction to The Clinical Research Profession Series goes into detail on the various acronyms and industry segments that are found across the realm of clinical research

A sponsor company is the one sponsoring or paying for the clinical research trial. This is a pharmaceutical company that, through research and development, has found a molecule or medical device that they think could help patients beyond what's already on the market. It's either a better product, or they think based on their current research that it's just as good as something else but has fewer side effects. These are both very important things that we want to offer people. They're the sponsor and they come up with the protocol, which is what you follow. They then must hire people to see the patients. This is the clinical research site.

A clinical research site has coordinators, called clinical research coordinators (CRCs). They are going to consent the patients along with the principal investigator or a sub-investigator. These are going to be physicians, dentists, psychologists, nurse practitioners, or physician's assistants. They're all going to help see the patient, just like they would see other patients, but this time it's going to be within the clinical trial at the site. These are all site-based people. Another category of people we are going to interview on this, and it's a very large part of our industry, are people associated with a CRO, or a clinical research organization. The people who work here are usually called CRAs, which can be clinical research assistants or clinical research associates, and they come out and monitor the data of the clinical research site and report it back.

They're an intermediary between the sponsor and the site, to help the sponsor company focus on what they do, which is finding new molecules and marketing those molecules. And while the sites are seeing the patients, the CROs are going to help do a lot of other things like hire vendors for labs, negotiate contracts, and monitor the data that the sites do. A sponsor does not always hire a CRO, but there will be someone at the sponsor doing that same job. So now you have CRAs at CROs and at sponsors.

The other category I'm going to interview about is the IRB, which is Institutional Review Board. This you should think of as an ethical review board. They're the people who do a lot of the regulatory work with the sponsor in writing their protocol and making sure that it's statistically correct and has enough people to get the data. What you don't want to have is people enter a clinical trial and it doesn't serve the purpose. A poorly written protocol, or one that doesn't seem to express itself well is not good for people in the industry. They also help write the informed consent documents for patients and help to make sure that they can be read by a lot of people. It’s ethics driven and it's something don't necessarily think about.

In summary, if you want to see patients, you're more likely to want to be on the site side, although there are jobs that don't see patients on the site side. If you want to go in and help with the data and review medical records and see that the site collected the data appropriately, that would be a CRA role. If you would like to be on the ethics side where you'll never see a patient and you're trying to help to make sure everything is ethically sound, that is the IRB side. I hope that helps as a primer. I know that was confusing but I put a lot of notes at the end so you can review, so stay tuned. I look forward to seeing you again next time!

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