What is a Principle Investigator?

We talk to Dr Elisa Fontana from the Sarah Cannon Research Institute about her role in clinical trials, what it's like to work on the next generation of cancer treatments, and what this means for current and future patients.

What is a Principle Investigator and what do they do?

A Principle Investigator (PI) is the physician responsible for the conduct of a clinical trial in a research site.

The PI is primarily responsible for the conduct of a clinical trial in accordance with the clinical trial protocol and to ensure patients’ safety.

The PI also provides guidance and mentorship on the clinical trial conduct to other researchers and doctors.

What inspired you to become a PI?

Being a PI in drug development is like living in the future of oncology care! 

As PI you have the real possibility to make a significant impact on the next generation treatments and ultimately on people lives. As PI you have the opportunity to offer your patients a potentially effective new treatment and an extra option of care beyond what is already available, but also you actively contribute in the development of future standards of care. I enjoy the impact that my role may have on the future of cancer treatments and also the responsibility that comes with the role. 

Why would patients take part in a clinical trial?

Because the trial may be the very first opportunity to receive a new drug or a new combination of drugs that might help controlling the cancer and possibly prolong life. Patients are offered clinical trials that have a robust rational as possible active treatment for their disease. We often match patients with trials that may target a weakness of the tumour based on their individual cancers characteristics.

For some patients a clinical trial may represent an alternative treatment option, but for some patients there are no other treatment options available as standard of care, and if these patients are very fit and well it is very frustrating not being able to try anything else. Many patients join clinical trials with the knowledge that this may benefit future patients as well as themselves and this is why I feel each of our trial patients are Principal Investigators! 

Are clinical trials safe?

Safety is paramount for any clinical trial. To be enrolled in a clinical trial patients need to fulfil a strict criteria. Clinical trials are regulated by stringent protocols that are in place and regularly reviewed and updated to make sure we take all the steps we can to minimise the risks. 

Of course, any trial or treatment comes with risks and this is why we work in a dedicated clinical research facility with highly trained staff. Our patients are frequently monitored with scans, bloods and clinic visits to ensure their safety.

How do patients find out if there are any clinical trials available to them?

I would always promote discussing clinical trial options with your oncologist because your doctor because they will be able to advise whether a trial is advisable for your cancer. At Sarah Cannon we have a wide network of clinicians enquiring all the time if trials are available for their patients and we keep the network very well informed. Patients might also find information from charities or websites, however I would always advise visiting reputable websites to ensure patients are not misinformed. We also have an enquiries email on our website open to anyone so we can help with the next steps.

What is the most rewarding part of being a PI?

The most rewarding part of my role is to be able to offer a patient a new treatment option and see the benefit that can bring. This benefit may be their disease shrinking, prolonging their life or improving their quality of life. 

Alongside this, it is incredible to be able to shape the development of a new drug, being able to match the drug with the right patient and finding more optimal doses and treatment schedule. Being able to think about what is the next step for that piece of research that you have contributed too, to design the next clinical trial that can really make an impact on people lives.