Why you should become a clinical trial volunteer

I’m not sure how many tubes of blood I donated in the end—not being fond of needles, I fixed my gaze over the nurse’s left shoulder throughout the proceedings. But it felt like a lot. And yet it also felt like it was the least I could do to give back.

I’m now one year into a five-year clinical trial studying my emotional response to the results of genomic sequencing, a relatively new type of test that digs into nearly every letter of your DNA code (unlike traditional genetic testing, which looks at only a few genes at a time).

One of the goals of the trial is to determine how useful genomic sequencing is for both doctors and patients. In addition to the bloodletting, all that’s required of me are periodic 30- to 60-minute Zoom interviews with the researchers for the first year and a half, after which the team will continue to study my health data quietly in the background.

As someone who has been successfully treated for two different types of cancer, I know just how important clinical trials are when it comes to finding new ways to detect, diagnose and treat disease.

Quite frankly, I wouldn’t be here otherwise. And it was thanks to the trial of a new drug that a cousin of mine, who had been diagnosed with a rare, and terminal, form of lung cancer, was able to spend an extra year with his young family.

In my case, scientists were looking for cancer patients who had been given a negative genetic test result and were open to receiving genomic sequencing in hopes of discovering a gene related to their disease.

Maybe it would help identify a new genetic link to cancer. Maybe it would offer my family answers about our seemingly genetic susceptibility to wayward cell mutations. And, just maybe, it would help lead to new treatments for future generations of cancer patients. To me, it’s humbling to be even a small part of that possibility.

All new vaccines and treatments go through a rigorous trial process, with help from volunteers

If you’ve ever shut down a case of the sniffles with cold medicine or hiked up your sleeve for a vaccine, it’s only because that treatment endured a long, thorough research process. No new treatment will be approved before it’s been through rigorous clinical trials.

According to Dr Jonathon Maguire, a paediatric scientist at the Li Ka Shing Knowledge Institute of St Michael’s Hospital in Toronto, clinical trials are the gold standard for determining the benefits and harms of any health intervention.

“We want healthcare to be as strong as it can be and for the risks to be as low as possible. For that, we need clinical trials,” he says.

There are three main types of health research: population research (correlational studies that look for relationships between two or more variables, say), laboratory studies with controlled experiments (think beakers and Bunsen burners) and clinical trials.

“A clinical trial assigns human participants to one or more treatments or interventions to study their effects,” says Alison Orth, the unit director of Clinical Trials BC at Michael Smith Health Research in Vancouver, and a former clinical trial participant herself (Orth was part of a study involving a new whooping cough vaccine that showed fewer side effects than its predecessor).

When the trial begins, Phase 1 is all about safety and side effects and involves small numbers of participants—maybe 20 to 80 at most.

“Once the intervention has demonstrated its safety, researchers then focus on how well it works in different populations with an increasing number of participants in the trial, often in multiple countries,” says Orth.

Phase 2, which can involve up to 300 people, studies whether the treatment works as expected, while Phase 3 looks at groups of 1,000 to 3,000 people to determine how the treatment compares to other options or a placebo.

Finally, once the treatment has proven itself, Phase 4 looks at its long-term effects. All of this can take up to ten years.

The scale of the COVID-19 emergency gave researchers unprecedented access to funding and collaborations

While the exact requirements for clinical trials and the standard of care differ slightly from country to country, trials generally follow this format worldwide, mirroring the World Health Organisation’s definition of a clinical trial that has three to five phases.

The speedy introduction of COVID-19 vaccines occurred because of an unprecedented collaboration between scientists, politicians and manufacturers on their combined quest for a safe medical solution to the pandemic.

Countries shared information and research findings, extra funding materialised, while red tape vanished and a lot of non-Covid research was put on hold. What would normally have taken years took months instead.

“It’s essential to understand that the Covid vaccines were developed based on science, technology and preparedness protocols that had been under clinical development and testing for some time before the pandemic,” says Orth.

But in addition to saving countless lives, the Covid vaccines may point the way toward faster clinical trials in the future.

Not all bodies react the same way to medicines, so we need a diverse cast of volunteers to take part in clinical trials

For these trials, researchers need participants. Unfortunately, not everyone is keen to play guinea pig. In 2019, Canadian researchers (Orth among them) published a survey of 1,602 people. They found that 49 per cent were “somewhat willing” to participate in a clinical trial.

On the other hand, 43 per cent said they didn’t feel very well informed about the trial process and 37 per cent didn’t have any opinion whatsoever.

While many people have no problem volunteering their time to other worthy causes, Maguire has seen first-hand a reluctance to volunteer for science.

He says that can stem from a fear of the potential risks (even though, he says, “The risks are very low—clinical trials are regulated by research ethics boards and they just don’t happen if they’re risky”) and a general sense of “What’s in it for me?”

It’s a fair question. For some, enrolling in a trial comes from pure altruism. Others, like me, enrol out of a sense of gratitude.

As one of Orth’s survey participants said, “Without previous clinical trials, I would not have received the excellent care and treatment plan. I feel it is paying it forward to be included and I hope that, when the trial is over, it will help other women in the future.”

For a long time, women weren’t explicitly required to be included in clinical trials. In Canada, for example, it wasn’t until 1997 that Health Canada decided they needed to be.

In Europe, EU regulations that came into effect last year state that clinical trial participants should represent the people likely to actually use the product, indicating an expectation of inclusion.

“Historically, clinical trials have lacked demographic diversity in their study populations,” says Orth. But everyone gets sick—and not everyone gets better the same way.

“People may react differently to the same treatment based on their age, sex, weight, race or ethnicity,” she continues. “It’s essential to include people in trials who closely reflect the population for whom the treatment is intended.”

Orth adds that there is finally a global recognition that we need to ensure better access and support for all communities to participate in clinical trials. However, it’s not always easy to get people to sign up.

“There’s still a degree of scepticism about science and the medical system as a whole,” says Maguire. He adds that we also don’t celebrate the people who participate in clinical trials enough, citing the Covid vaccine trials as an example.

“Every one of those people saved a lot of lives,” Maguire explains. “They’re heroes.”

The World Health Organisation offers a search portal for both ongoing and completed trials, so you can track any interesting new treatments on the horizon. For its part, the United States National Institutes of Health has set up a comprehensive database of more than 400,000 clinical studies in some 150 countries.

Another option is to ask your GP about clinical trials that might be a good fit for you. While you don’t necessarily need a doctor’s referral, it can be helpful to have an expert take you through the risks and benefits of participating in a trial.

Local university-affiliated hospitals, medical centres and patient-support groups are also excellent places to learn about clinical trials in your area.

For people who still aren’t quite sure they want to be part of an experiment, paediatric scientist Dr Jonathon Maguire recommends checking out the People’s Trial. The website, created by a health-research board in Ireland, asks people from around the world what questions they’d like answered. It then sets up trials to find those answers.

One submission: whether reading a book in bed makes a difference to sleep. It turns out that 42 per cent of people felt their sleep improved after they read a book in bed. Thank you, science.

Read more: What is the future of medicine?

Read more: 6 New treatments that could save your life

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