Celebrating International Clinical Trials Day on May 20, 2019

Why do we celebrate International Clinical Trials Day?

Every year on May 20, International Clinical Trials Day commemorates the day James Lind started his study to determine the causes of scurvy in 1747.

As a surgeon serving aboard a Royal Navy ship, Lind took 12 sick sailors with scurvy, and experimented with a variety of dietary supplements including cider, oranges, and lemons. Those treated with citrus fruits made remarkable recovery over six days, providing Lind with evidence that citrus fruits helped ward off scurvy.

His work not only saved the lives of the sailors, it laid the foundation for modern clinical trials as we know them today. Clinical trials have evolved tremendously, and they are now vital part of clinical research and healthcare advancement.

To recognize International Clinical Trials Day, taking place next week, we sat down with a couple of physician-researchers, a clinical trials study nurse, and two patients to get their perspective on the importance of clinical trials.  Here's what they had to say:

Dr. Daniel Heng, Physician-Researcher

What is the difference between clinical health research and a clinical research trial?

"Clinical trials include a very specific population - where we are trying to determine if one treatment, device, or technology is better than another.  It's the only way we can advance a particular treatment for our patients.  For example, it helps us identify how safe and effective certain medicines and drugs are and which patients will benefit the most from those drugs."

What prompted you to consider research as a career?

"At the Tom Baker Cancer Centre, at any given time, there are 150 active and ongoing clinical trials, recruiting 500 patients a year.  We also follow thousands of clinical trial participants once they're done their drug treatment. I got involved in research because in medicine we're continually asking ourselves what's a better way of doing something?  How can we improve what we're doing? We answer those questions by doing clinical research. While I was in medical school, I knew that I wanted some element of research in my career.

Clinical trials are a way for our patients to experience the most cutting edge medications, technology, and care pathways.  I always encourage our cancer patients to ask about clinical trials!

Linda Soltys, Clinical Trial Participant

Why did you decide to participate in a clinical trial?

"I was so excited when I found out I could participate in one because it's very important to me. It's the cutting edge. You're getting a new treatment. And, you're hopeful that maybe this will be the next miracle drug. If it doesn't help you directly, it's going to help someone else.

It also helps me stay on top of my blood work, my health, and if there were any changes, we'd know about them right away. I see that as a really positive thing. It's just become part of our life. And, things are going very well.

I would tell others to jump at the opportunity [to participate in a clinical trial]. You have nothing to lose. If it isn't working, you can be switched on to something else. You never know, the results might be phenomenal."

Barb Gore-Hickman, Clinical Trial Study Nurse

What led to you becoming a clinical trials study nurse?  What has changed since you first started?

"I've been doing clinical trials for about 18 years. I had been an oncology nurse for a number of years and we had patients who were enrolled in clinical trials and because their treatment was substantially different, my roll evolved over time.

Research nurses are part of a clinical team, along with doctors and research coordinators. My job is to take over once the doctor has informed the patient about the clinical trial. I go through the screening process and make sure the patients meet all the eligibility criteria. I meet with patients to discuss a treatment plan, what patients can expect while enrolled in the study, what drugs they'll receive, and any possible side-effects. I ensure that the patients are taking the drugs correctly. I'm there to answer any questions they, or their families, may have.

Evaluating patients for clinical trail eligibility is a lot more complex, today, than it used to be. When I first started, trials may not have even been double-blinded, like they are today. They're more complex, more drugs, more visits, more monitoring, more side-effects. I'm fortunate because I get to spend more time with patients."

Peter Oxland, Research Participant

How did you become involved in clinical research? What has your role been?

"I seem to have been involved in a lot of research. Results from studies I've participated in have been used to help inform [policies and procedures] within the Intensive Care Unit (ICU). That has also led to a further study around Late Life Issues in the ICU and projects related to Transition in Care - which look at the transition from the ICU to a hospital ward or to one's home.

The Evidence Care Gap Study I participated in looked at the evidence in the gaps of care within intensive care. What we heard from the qualitative study participants [ICU patients and family members] was that they expected they were receiving the best clinical care possible. Patients and family members were focused on their experience during their time in the ICU. This work led to understanding what is important to ICU patients and family members and contributed to developing the top five research priorities for the ICU."

Dr. Tom Stelfox, Physician-Researcher

Tell me about your work and how does it intersect with clinical trials?

"I started doing research as an undergraduate student which led to me working on a measles vaccine during my time at medical school - and that got me hooked. Now I focus on research into healthcare delivery - examining how we get people the care they need at the right time and in the right ways. I moved to Alberta in 2006 and have been part of many clinical trials since that time.

For the past several years we've been engaging patients, patient advisors, and family advisors into the research since the research directly benefits them. Historically, there has been lots of Drug-A vs. Drug-B trials, which are very important, and now we're looking at ways to measure Practice-A vs. Practice-B, which can be more complicated.

Recently the broader critical care community in Alberta was involved in a pragmatic clinical trial, where one group of ICUs used a new approach to preventing blood clots while another group of ICUs used the standard approach.

We're also engaged in looking at partnering with patients and family members to help with recruitment. In one trial, we're looking at how do we detect delirium.  What we've seen is that if we engage former patients, or family members of patients, to be part of the research team, accrual into the study goes way up. People are a little more willing to participate. It's that experiential connection where a person is talking about their experience and that's what has engaged others to participate.

Alberta is a learning healthcare system - where research and education are seamlessly integrated into patient care. Every time we care for a patient, there's an opportunity to learn both for today and into the future.  And, I think that's what we all want to aspire to. Research is a key component of making that happen."

More about clinical trials

A clinical trial is a type of clinical health research study that is designed to assess the effect of a biomedical intervention (e.g. drug, device, cognitive-behavioral, process, diagnostic test, etc.). Clinical trials are incorporated into and are an inextricable part of advanced clinical care.

To know more about Clinical trials in Alberta or join one, visit Be the Cure.

More about ACRC

The ACRC supports researchers by promoting quality and efficient clinical health research in the province. In collaboration with our partner organizations, the ACRC has developed pragmatic tools and resources to guide clinical health researchers in best practices from study start-up through to close-out. Available resources include:

• Alberta Clinical Research Roadmap
• Glossary and Common Terminology
• Provincial Training Recommendations
• The Clinical Research Source
• Alberta CHR Digest

Let us know how your organization/group is celebrating the 2019 International Clinical Trials Day on May 20, 2019! Share with us