Celebrating Clinical Trials Day

By Mark Legacy, CCRP


 

May 20th is clinical trials day! A day for recognizing all the work done by clinical research professionals across the world. We thought we would take this opportunity to explain what a clinical trial is, why this day is important, and what clinical trials are currently being conducted at the Patterson Institute for Integrative Oncology Research.



 

What is a clinical trial?

A clinical trial is a type of research study which gathers information on the effects of a drug, natural product, medical device, or other type of investigational product. This information could include side effects, how the product works in the body, or how effective it is at treating some kind of condition. Clinical trials fall under the umbrella of clinical research, which is research conducted on humans. What distinguishes clinical trials from other clinical research, such as observational research, is that a clinical trial gathers information on an investigational product. This is an intervention which is not considered part of usual care. For example, testing a new drug or an approved drug for a new condition.  

There are four types of clinical trial phases. Phase I trials are the introduction of a new product in humans. They are designed to determine the safety of the product and how it works in the body. Phase II and III trials take products which are already deemed safe and evaluate their effectiveness for a particular indication or illness. The difference between phase II and III trials is the number of patients; phase II trials typically have less than 100 patients, whereas phase III trials can range from several hundred to several thousand. Finally, phase IV trials are called post-marketing studies and are designed to gain additional information about a product’s risks, benefits, and optimal use after it is approved. For example, researchers often study different doses or dose schedules of a drug to determine what is most optimal. 

 

What is clinical trials day? 

Clinical trials day is organized and promoted by the Association of Clinical Research Professionals (ACRP), which is “the only non-profit organization solely dedicated to representing, supporting, and advocating for clinical research professionals.” Clinical trials day is an opportunity to recognize all that has been done thanks to clinical trials and the people who conduct them. It is celebrated on May 20th to commemorate the first randomized trial, which took place in 1774. The campaign this year is “The Trailblazers Among Us.” You can read more about the ACRP’s campaign for clinical trials day at https://clinicaltrialsday.org.

 

What clinical trials are being conducted at the Patterson Institute? 

The Patterson Institute conducts clinical trials in “integrative oncology”, which is the use of complementary therapies used alongside conventional cancer treatments. We currently have two active and approved clinical trials, named POISE and AIVAA.
 

The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial (POISE) 

The POISE trial is a phase III clinical trial with the goal of studying the real-world impact of naturopathic medicine on the quality of life of patients with gastric, lung, or esophageal cancer undergoing surgery for their cancer. We are conducting this study in collaboration with The Ottawa Hospital. The basic structure is the same as any standard clinical trial; however, instead of a drug or natural product, we are studying the addition of an entire practitioner to patient care! Participants are divided into two groups: integrative care (i.e., standard care plus naturopathic care) or standard care alone. Although simple in theory, in practice this is the most complex study the Patterson Institute has ever conducted. Study participants in the integrative arm receive protocolized recommendations from a naturopathic doctor (ND), including supplements, nutrition and exercise advice, and mental health support. Although complex, this type of study represents the real world much better than other studies which may only focus on a single aspect of naturopathic care (like a single supplement or single dietary change). We have enrolled 37 people in this study so far and aim to enroll 350 over the next four years. This study is also recruiting patients from Michael Garron Hospital in Toronto and the Queen Elizabeth II Health Sciences Centre in Halifax. 

 

Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer (AIVAA) 

The AIVAA trial is a phase II clinical trial once again conducted in collaboration with The Ottawa Hospital. The purpose of the study is to evaluate the impact of intravenous vitamin C (IVC) on the quality of life of patients with incurable lung cancer undergoing chemotherapy. Patients in the study get placed into one of two groups: chemotherapy plus IVC or chemotherapy plus a placebo. A placebo is an inactive substance that looks, tastes, and feels the same as a product with active medicinal ingredients. Placebos are often used in clinical trials because it is well known that the act of taking a pill or other type of product can cause real physical or psychological changes, even if there are no active medicinal ingredients in the product. Because of this, we need to make sure that any effects we notice are due to the actual product, and not the placebo effect. To make things more controlled, the study is double-blinded, which means neither the patient nor the people conducting the study know if participants are receiving IVC or a placebo. Although IVC is used in many integrative care clinics, it is still considered experimental. This is the first blinded and placebo-controlled trial of IVC that has been conducted in Canada for people with cancer, and one of only a handful conducted in the world. Recruitment is expected to start in the coming months, and we hope to enroll 90 patients over 5 years. 

 

The importance of clinical trials and integrative oncology research 

The number of people with cancer seeking integrative therapies continues to increase. The Patterson Institute’s goal is to ensure that the integrative therapies people are choosing are not harmful, will be effective, and will not interfere with standard cancer treatment. Clinical trials are an important part of any research program as they usually offer the best chance to answer these questions. Unfortunately, high-quality clinical trials are lacking for most integrative therapies, especially those used within cancer care. By conducting these trials and making this information readily available, we hope to support patients and their health-care providers in making the best evidence-informed decisions they can.  

To stay up to date with the Patterson Institute’s work, check out our website and follow us on social media.

 


MarkAuthor:  Mark Legacy, CCRP

Mark is a full-time clinical trial coordinator with the Patterson Institute for Integrative Oncology Research. He is involved in the development, implementation, day-to-day activities, and publication of all clinical research conducted at the CHI. Mark joined Dr. Dugald Seely, ND’s research team in 2018 after volunteering with his brother, Dr. Andrew Seely, at The Ottawa Hospital. Mark is also an employee of The Ottawa Hospital Research Institute, a Certified Clinical Research Professional (CCRP), and an active member of the Ottawa Health Sciences Network Research Ethics Board.