As a scientist, patient advocate and healthcare consumer, I know clinical trials are essential in the research and development of new treatments that encompass everything from drugs to innovative medical devices, lifestyle changes and other valuable healthcare interventions.
While most people think of scientists and doctors developing life-changing treatments, in reality, people like you – healthy people and those of us who live with diseases and medical conditions – are a vital part of the process. Clinical trials are a key step in creating new ways to prevent, diagnose, understand and treat disease.
However, clinical trials don’t happen without volunteer participants and I hold these people in very high esteem. Thanks to the generous people who commit to clinical trials, I am able to live the life I want with rheumatoid arthritis, rather than be beholden to the life my rheumatoid arthritis wants me to live.
Clinical trials touch us all. Many everyday medications are available because of clinical trials so chances are you’ve benefited, too. Maybe you have participated in a clinical trial – thank you – or you’re considering getting involved. If so, here’s some inspiration.
Comeback highlights inspiring stories of aging, recovery and people building new and rewarding lives in the face of health challenges. This time, we’re profiling individuals who have made incredible contributions by participating in clinical trials. And, we’re giving you the resources to become an everyday hero.
His life’s work: Myeloma Canada founder Aldo Del Col
In late 2001, Montreal-based Aldo Del Col knew something wasn’t right – the self-proclaimed workaholic usually had boundless energy, but was dealing with general malaise and fatigue. The then-48-year-old soldiered on for three months before seeing a doctor. Blood tests revealed he was very anemic, which explained the fatigue, with an alarmingly elevated serum protein level.
This was March, and an appointment to see a hematologist for a bone marrow biopsy was scheduled for September – a six-month wait, during which he developed severe bone pain and recurrent infections.
Of course, he researched his symptoms online, with the unfiltered information causing severe anxiety and stress. “The word myeloma kept appearing,” he says. “I had never heard about this disease, but the search results made it clear that it was incurable and that I should expect to have only three to five years left to live.”
He still recalls the exact day he was officially diagnosed with multiple myeloma – September 12. “The first thing I wanted to know was if there was a support group in Montreal and if there was a clinical trial for me. There wasn’t a support group, which I put on my to-do list, but there was a clinical trial.”
Del Col started a high-dose chemotherapy treatment (more widely known as an autologous stem cell transplant, which was and continues to be the standard-of-care treatment for most newly diagnosed patients) and by spring 2003, with the help of his hematologist, he started a clinical trial. He put his business acumen to good use, tracking information about his treatments and blood work results on a spreadsheet.
Del Col was enrolled in the “control” arm of an open-label study, which he knew meant observation only, not active treatment: “[It]was my small personal contribution to advancing the understanding of the disease, the treatment and science overall.”
He participated for two-and-a-half years until regular blood work showed his disease was becoming more active. With research, including clinical trials, continuing to move the field forward in myeloma treatment, he was able to try another type of therapy: “I wouldn’t be alive today if people hadn’t participated in clinical trials.”
As he navigated this new world, Del Col found that there were few Canadian-specific resources for patients. In 2004, he founded Myeloma Canada: “It is a grassroots, patient-driven organization, whose mandate is to improve the lives of people impacted by myeloma through education, awareness, advocacy, clinical research and community building.”
In 2017, the Myeloma Clinical Research Network (MCRN) officially became a sister organization of Myeloma Canada, which focuses on delivering made-in-Canada clinical trials. MCRN brings together world-class Canadian researchers and patient advocates accelerating Canadian myeloma research and helping people gain access to new therapies faster.
“Clinical trials are not a final option,” stresses Del Col. “They should be considered at any time in your journey and allow you the opportunity to do something for yourself and for the greater myeloma community.”
Coming through the fog: Gail Bellissimo
Although not clinically diagnosed until her 40s, Gail Bellissimo recalls living with depression on and off throughout her life and describes it as “extraordinarily heavy. I have no energy, there is just a heaviness – unable to feel the joy in life, despite having a great family and friends, my mind is heavy with worry and rumination.”
For years, she was convinced that her incessant rumination was a character flaw, but with her 2010 diagnosis and proper treatment, things got a bit better.
Sessions with a psychiatrist helped, but although she tried mindfulness, exercise and many different types of pharmaceutical treatments, nothing completely alleviated her symptoms. “I felt a heavy, thick fog that was an enormous physical weight on me,” she recalls. “I could not sleep and my daily function was limited due to an inability to concentrate.”
But she didn’t give up, scouring the Internet for solutions and information about clinical trials. Initial clinical trials for treatment-resistant depression were being conducted only in the US. However, she monitored this and in 2014 found a clinical trial opening at the Centre for Addiction and Mental Health (CAMH) in Toronto.
The trial involved repetitive transcranial magnetic stimulation, whereby specific areas of the brain are stimulated with magnetic pulses. Bellissimo knew there were no guarantees, but she decided to participate anyway and after providing a complete medical history and having an MRI, she qualified for the study and then waited four months for the trial to start.
The trial was intense: For four weeks, five days a week, she commuted from the suburbs to CAMH in downtown Toronto for the 30- to 45-minute sessions. Then, because she was doing well, she continued for two more weeks.
Her parking expense was covered, but the trial still represented a massive commitment of time and resources. Happily, that commitment paid back for her.
“One day I was driving home from a session and I found myself near the lakeshore and it dawned on me,” she recalls. “Everything seemed more vibrant, the fog was gone, the lake was bright and sparkly, I could hear the birds singing and the traffic. It was a bit freaky.” Her ruminating and worrying were gone.
Bellissimo continues to have TMS maintenance therapy – about four sessions since her participation in the trial wrapped up five years ago – and her depression is in remission.
In the beginning, she kept the clinical trial from everyone except her husband. But now Bellissimo speaks publicly about her experience in order to help others and break the stigma. She also volunteers with CAMH and is directly involved in the redevelopment of www.camhstudies.ca, which helps connect people with research studies.
“Research improved my quality of life exponentially,” says Bellissimo, who wants to give people hope. Just as research helped lift the fog that enveloped her, she is determined that in speaking out and advocating, she can help do the same for others.
Finding strength in new treatments: Patricia “Deedee” Lannon
For years, Patricia “Deedee” Lannon experienced inordinate joint pain, but it wasn’t until her family physician recognized her symptoms as rheumatoid arthritis (RA) that she was referred to a specialist for official diagnosis and treatment.
It was 1997 and her specialist recommended Lannon leave her job as an Air Canada customer service agent, as RA was making even the simplest tasks, such as having the strength to turn the key in the ignition of her car, unattainable.
From the beginning, Lannon was determined to learn as much as she could about the disease – that now affects her hands, feet, ankles, elbows, shoulders, and jaw – and take control where she could.
Today, Lannon is 68 and while her life with RA will always have its ups and downs based on the unknown whims of her disease, she remains optimistic, independent and self-driven.
It’s that attitude that prompted her to consider a clinical trial. Having returned home in 2000 to St. John’s after living in Prince Edward Island, she was unhappy with her disease state. “I had a very poor quality of life, my medications weren’t doing what I needed them to, I was constantly fatigued, and I couldn’t even walk up stairs. I had pain 24/7 and was doing my best to hide it and stay positive.”
One day in 2002 she noticed a newspaper ad featuring a well-known rheumatologist looking for clinical trial participants. She called right away and soon completed numerous screening tests, including a TB test and plenty of blood work, before being accepted.
Lannon was part of the study for two years, which involved taking medications at home, visiting the hospital each month for an infusion and filling out ongoing study surveys (a critical part of the process). She wasn’t told if she was receiving active or placebo treatments, however, she soon noticed a change in her RA symptoms. “It didn’t take me as long to get up in the morning, I was not as tired, and it’s as simple as the fact that I could function again.”
The clinical trial afforded Lannon the opportunity to gain access to what was then a new treatment called a biologic. After the study, she continued the treatment for two years, until it no longer worked for her. (This is typical with RA – people often try and exhaust many types of medications.)
Lannon says one of the most valuable things she did during the trial, and continues to do today, is keep a diary – she advises others to do the same. “I track my RA and how I’m feeling. If a medication isn’t working the same as it once was, I note the date and information so I can go back and share this with my healthcare team.” She relies on that team, which also includes a nurse practitioner and her pharmacists, to provide information about her complex medications so she can be an active participant in her care. She says participating in a clinical trial helped her access good care and achieve better overall health.
How do I find a clinical trial?
FIRST STOP: For everything you need to know about clinical trials and where to find them, visit Network of Networks’ website www.itstartswithme.ca (French version) which was developed in collaboration with patients and caregivers. You can also speak to your healthcare provider or visit: www.clinicaltrials.gov.
Clinical Trials 101
What types are there?
• Prevention trials look for new ways to prevent illness.
• Screening trials help detect diseases or conditions.
• Treatment trials test new types of treatments.
How do they work?
Clinical trials involving new medications are done in a series of steps called phases so that researchers can learn about new medications in a gradual and safe way. Phase 1 is generally the first time these medications are given to people. Participants are closely monitored throughout each phase. Information and results from one phase are used to help design the next phase, and the clinical trial moves on to the next phase only when the previous phase’s results are considered positive.
• Phase 1 – Is it safe? It usually involves 20 to 80 people to ensure the treatment is safe, determine how much treatment or medication is needed, and evaluate side effects.
• Phase 2 – Does it do what it’s supposed to? It usually involves 100 to 300 people with the medical condition who are watched to see whether the treatment works as expected and to further evaluate safety and dose.
• Phase 3 – How does it compare? Larger groups of 1,000 to 3,000 volunteers are monitored to continue observing side effects and to see how well a treatment works in the long term, how long its effects last, and how it compares to current treatments or a placebo.
• Phase 4 – What happens long term? After a treatment is approved, a large population is studied to determine the long-term effects, safety and whether existing therapies should be replaced.
Are you ready?
Participating in a clinical trial is a highly personal decision, with rewards and risks. Here’s what to ask your healthcare or clinical trial team:
What is the purpose of the study?
What is the phase of the study?
Who is going to be in the study?
Will being in a clinical trial affect my medical care?
Why do researchers believe the new treatment being tested may be effective? Has it been tested before? How is the treatment different from the current therapies or standard of care?
What kinds of tests and treatments are involved?
What are the requirements to be part of the study? Do I qualify? What sort of tests will be done to determine whether I qualify for the study?
What are the possible risks, side effects and benefits of the study?
How will the clinical trial affect my daily life?
How long will the trial last?
Will I need to be in the hospital? Will the study be an in-patient or out-patient study?
What is the treatment schedule?
Who will pay for the treatment?
Will I be reimbursed for other expenses (for example, if I have to drive and pay for parking)?
How will I know that the treatment is working?
What happens when the clinical trial ends?
Will I find out the results of the clinical trial?
Will I be able to use the new treatment when the study is finished?
Will I be able to find out the results of the study?
Who can I talk to about the clinical trial?
Who can I talk to if I have any concerns about my treatment?
Will participating in this clinical trial prevent me from participating in other clinical trials in the future?
Originally published in Issue 02 of YouAreUNLTD Magazine (August 2018)