building the clinical research workforce to bring new treatments to canadians
8 minute read
the lack of standardized credentialing, training and education for clinical research coordinators and assistants impacts clinical trial quality and efficiency.
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during covid-19, the world focused on developing a vaccine with the research and clinical trials necessary to deliver an effective and safe formulation. in the aftermath of the pandemic, canada has pushed initiatives to overhaul our clinical trials ecosystem to make it more efficient and attractive for companies to do this critical work in canada. there’s a roadmap for improvements well underway, including more investment in canada’s biotech sector, a single national ethics review platform, better data sharing and more inclusive patient access to clinical trials.
but one aspect of clinical trials has been largely overlooked until recently—the clinical trials workforce. these are the people on the frontlines who coordinate the studies, screen patients and enroll patients with consenting documentation. they’re the ones who bring them into the hospital for study visits, collect samples and upload information to various online platforms as clinical trials, much like most sectors, have become increasingly reliant on technology.
typically, these people move from temporary contract to temporary contract or leave the field for other job opportunities.
clinical trials workforce delivers scientific discovery
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“in clinical trials, all of the pieces that do need efficiency have been addressed or have been identified and they’re aiming to address. but the one piece that has been missing from all of those conversations is the actual people that are going to deliver the clinical trials,” says munaza jamil, instructor with the applied clinical research program at mcmaster continuing education in hamilton, ontario.
she began her career as a volunteer in clinical research, then worked in many roles in clinical trials from student to research assistant, coordinator, manager and is now leading change to create the designation clinical research professional (crp) as a credentialed profession with career pathways.
she’s the national director of canada’s clinical research workforce strategy, a pan-canadian initiative to build the talent pipeline in the field. the strategy aims to make crps recognized, supported and elevated at a national level.
“world-class discovery is amazing if canada can host it,” jamil says of the federal government’s investment of $1.2 billion to attract leading international researchers to canada and make our country the global destination for clinical trials.
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“what is world-class discovery without world-class delivery? what if you don’t have anybody to transform that discovery and bring it to the people?” she says. “if you don’t have a strong, well-supported, well-recognized, credentialed, research-ready workforce, you’re still going to have the same problems on the ground that you’ve always had.”
the united kingdom (u.k.) is well ahead on this, with a health occupation code for crps in place as well as a directory of registered crps and regulations through the academy for healthcare science (ahcs) professional standards authority. as the u.k. national institute of health and care research states, “clinical research practitioners (crps) work to deliver safe, ethical and high-quality clinical research care. they make up around 25 per cent of the research workforce.”
australia, japan and the u.s., among others, are working toward a similar professional framework, she notes.
why is this important for canadians?
credentials, training, expertise critical for clinical trials coordinators and assistants
jamil explains that the lack of standardized credentialing, training and education impacts clinical trial quality and efficiency, undermining what can be a large investment by drug companies, for instance, and new therapies reaching canadians. in other words, your health could be affected.
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clinical trials in oncology, pediatrics and rare diseases are three key areas because there are so few therapeutic options available to patients, so participation in a clinical trial or special access to innovative therapies can be lifesaving.
for context, she gives a possible scenario in oncology, where a pharma company decides to open five clinical trial sites in five cancer centres in canada to trial a drug for lung cancer. a study coordinator is hired, but if that person is not well trained, or doesn’t understand how to interpret results properly, how to take tumour tissue samples, how to ship them properly, how to navigate all of the scanning and uploading of information online, that means “you are going to take longer to conduct your trial because there’s going to be more mistakes made. it’s going to cost you more money because your trial timeline shifts.”
as a result, the data quality is affected and, most importantly, patient safety could be compromised, jamil notes. right now, there’s minimal online training that gets you a certificate to be employed in clinical trials. people can come in from anywhere, with or without any type of science background, and “spend eight hours a day completing all of these trainings but not understand a single thing (about how to apply the training). at the end of the day, what that means is that they are touching your parent, your baby in the icu, maybe somebody who’s really ill, somebody who’s in emergency, somebody who’s broken a bone, all of the different places where research is happening.”
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as she puts it, “would you want any healthcare worker to be close to your family who doesn’t know what they’re doing? would you want them to be doing blood tests and scans and all these kinds of different things that are part of the protocol, who doesn’t understand what they’re doing? never.”
building research capacity in community hospitals
dr. jennifer tsang sees exactly how this plays out in her research. she’s an icu specialist with niagara health, a large system of community hospitals in niagara, ontario, where she’s focused on building research capacity in niagara health and community hospitals across the country. tsang also helped establish the niagara health knowledge institute in 2023 and serves as executive director and chief scientist. she also leads clinical trials in the icu, where a clinical research coordinator “is sort of embedded in the icu clinical team,” where they work with the team to identify eligible patients and make sure that it’s okay for them to approach the patient or the substitute decision maker. the icu patient is often too sick to be able to give consent.
tsang says that a lot of the icu clinical trials are very time sensitive because of the severity of the patient’s condition, so there’s an urgency to get people into the study quickly, which requires a skilled and knowledgeable team, including the coordinator.
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“for one of the trials, the enrolment window was six hours from the emergency department, for example. so, then you need very skilled staff. not only that, but also very skilled and compassionate staff because they are speaking to individuals who are at the worst time of their life,” she explains.
“they need important soft skills to be able to do that. they have to be highly trained also to be able to follow up on all the complex intervention and liaising with the clinical team, the nurses, the respiratory therapist because we often do studies on the mechanical ventilators, on drugs, on a physical therapy and on nutrition. so they have to have very broad range of knowledge to be able to understand complex study interventions.”
when these temporary clinical research workers jump to another opportunity during a study, there’s a delay in the trial because of the hiring and training time for a replacement. tsang, who consulted on the clinical research workforce strategy, sees the strategy as a big step forward to creating a quality workforce that will help grow and attract more clinical trials to canada, and bring them to community hospitals so discovery can reach more canadians.
she points out that more than 90 per cent of hospitals in canada are considered non-academic hospitals, although most health research historically is conducted in academic hospitals. “so you are missing out on 90 per cent of your patient population. the impact is multi-layered. when you’re only including 10 per cent of hospitals, you’re not going to have enough patients enrolled in clinical trials, so your study is going to take longer.” she adds that the result of your study might not be applicable to all canadians because you’re only selecting from certain populations.
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another issue is that many patients who don’t live near large academic hospitals are not getting access to innovative therapy.
“for those who failed with the traditional treatment plan, the only way they can access innovative therapy is through clinical trials. and folks who are cared for in community hospitals may not have access to the trial or they have to travel long distances to get access to the trial. when you’re ill, do you really want to travel that far?”
tsang also says that hospitals that do research have better quality of care, better patient outcomes, and hospital staff have better job satisfaction and better retention.
ultimately, building capacity in the clinical research workforce is a significant step toward the “paradigm shift” that would embed health service delivery and health research. “your nurses, your physiotherapist, your respiratory therapist, pharmacist and physician are licensed individuals. they work in a hospital. they’re funded by the hospital operating budget.”
the research coordinators and research assistants, on the other hand, are not regulated or funded out of the hospital budget. they are always on a temporary contract and funded externally by grants, pharma sponsors or research funds from the canadian institutes of health research.
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therein lies the fundamental problem, tsang explains: “people don’t see research as part of healthcare. healthcare research doesn’t have stable funding like healthcare. the next step will be to put this individual (crp) as part of the hospital workforce and not to separate them out from your other healthcare providers, and to put them under the hospital operating budget. so that’s the step the workforce strategy doesn’t cover, which is the next step in negotiation.”
tapping into foreign-trained medical talent
meanwhile, jamil also sees the clinical workforce strategy as a way to help newcomers to canada, especially women, which reflects some of her related work on inclusivity for participation in clinical trials.
“i would think 90 per cent of clinical research roles are held by women. so it’s not a women-only sector, but it’s a women-dominated workforce. and when you have women who already face different types of barriers when pursuing careers and in the workplace, when they don’t have advancement pathways that are clear and transparent, there is going to be a lot of inflow and outflow. that woman is going to have more problems succeeding in her career,” she explains.
jamil also notes the foreign-trained scientific and medical talent in canada right now who want to pursue research as their career of choice, but can’t transition into the system because their foreign credentials and competencies are not being recognized by the sector.
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“we need to create a bridge for those foreign-trained professionals” to tap into that talent.
the mood and momentum toward these goals is positive, she says.
“there is appetite to receive this kind of strategy amongst most organizations and institutions that we’ve consulted with. we’ve had, in the last six months, over 40 conversations with 40 different organizations across the sector. so that’s government, that’s academia, that’s industry and that’s education. and there’s, by and large, a 100 per cent positive response rate. we do see this going forward.”
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