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the future of clinical trials: bringing hybrid and decentralized methods to all canadians

the covid-19 pandemic brought unexpected change to the world of clinical trials, forcing the conductors of such studies to explore new and more flexible ways to perform medical research.

by andrew robichaud and raby nguer

jul 23 2024

4 minute read

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hybrid clinical trials combine in-person visits with remote data collection, offering a mix of both worlds. decentralized trials use technology to run the entire study remotely. getty images

the covid-19 pandemic brought unexpected change to the world of clinical trials, forcing the conductors of such studies to explore new and more flexible ways to perform medical research.

traditionally, these trials involve face-to-face visits where healthcare professionals closely monitor participants and collect the necessary data, however, pandemic safety protocols and regulations meant participants in clinical trials were not allowed to appear in person.

dawn richards, director of patient and public engagement for clinical trials ontario (cto), and heather douglas, a member of cto’s college of lived experience , were on the frontlines of the impact of the pandemic and recognized the need to understand new ways to make sure patients could continue to access important clinical trials.

together, the organizations came up with a survey to ask canadians about hybrid and decentralized trials – the goal to understand what canadians thought about these types of trials, if they could see the potential benefits and if they were more or less likely to participate.

hybrid trials combine in-person visits with remote data collection, offering a mix of both worlds. decentralized trials use technology to run the entire study remotely, reducing the need for participants to travel to clinical sites.

“initially, conversations took place at the start of covid when things pivoted to decentralized approaches for the safety of the team and the participants,” richards told healthing.ca in an email. “clinical trials ontario (cto) was doing work with people in the trials community and they were figuring out how to quickly move this to a virtual world.”

for douglas, who lives with metastatic breast cancer, recognizing the shortcomings of the clinical trials process came before the pandemic.

“i’ve made friends with others living with metastatic breast cancer who also needed new options, but didn’t have the financial, time, health energy and/or caregiver support to access travelling to trials,” douglas said. “hybrid and decentralized options might have allowed them to benefit from emerging treatments and have more time with their families.”

the results of the survey validated their intuition – 79 percent of respondents showed interest in more options for clinical trials, including virtual, in-person and at-home opportunities.

“we learned that people in canada want to see a range of options for participating in clinical trials,” president and ceo of clinical trials ontario susan marlin said in a press release. “our hope is that these results will be considered by those who conduct trials and that they will have implications for policies and regulations related to clinical trials in canada.”

the new challenge that emerges is how to effectively bring these different methods of clinical trials to all canadians? it starts with a conversation.

“we need to keep talking about our paper and findings to show the ‘system’ that people are open to clinical trials but need some help with getting past barriers,” douglas said, later continuing. “many of my fellow college of lived experience members are members for the same reason as i am – we want others to have access to the benefits of clinical trial benefits.”

“besides sharing the results in our paper, which is a start to get people in the trials community to see the results, we are going to be working with our co-authors and our college members generally to start to share results,” richards echoed. “ this is also the start of more work together with the clinical trials community as a whole to help them see that participants would like options and to get them thinking more broadly about this.”

cto and the college of lived experiences also recognize the need for more diversity in the responses to the survey and the solutions they develop to improve access to clinical trials for all canadians.

while the age ranges represented a broader spectrum of participants – youngest being 20 and oldest being 83 – the race, gender and location did not. out of the total respondents:

76.6 per cent identified as women
84.9 per cent identified as white/caucasian
91.4 per cent identified living in an urban area

so while the survey indicates canadians are interested in hybrid and decentralized clinical trials, it leaves out a large contingent of voices that represent other genders, ethnicities and those living outside of city centres.

“our results are a start. to our knowledge, this type of survey has not been done yet in canada and it’s a start to collecting data about public perceptions related to decentralized and hybrid trials,” richards said. “when we continue our work in this area, we will purposefully seek to include perspectives and voices that weren’t captured in our survey.”

it’s all part of the next steps to bring the results of the survey to reality, where patients have the option to participate in clinical trials in-person, remotely, or a combination of both.

richards and douglas continue to advocate to the clinical trial community and seek out more diverse perspectives, including upcoming conference presentations and ongoing conversations with relevant stakeholders to keep the conversation alive.

“we’d love to hear from the community about how we can help them implement these results,” richards said, “and also work with them to develop practical tools to do so.”

the future of clinical trials: bringing hybrid and decentralized methods to all canadians

the covid-19 pandemic brought unexpected change to the world of clinical trials, forcing the conductors of such studies to explore new and more flexible ways to perform medical research.

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the future of clinical trials: bringing hybrid and decentralized methods to all canadians

the covid-19 pandemic brought unexpected change to the world of clinical trials, forcing the conductors of such studies to explore new and more flexible ways to perform medical research.

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