Where the blood hits the bench — the challenges of sharing health research material

Health researchers and technology developers are calling for easier access to patient biological samples and other data in wake of the Covid-19 pandemic.

Dr. Terry Pearson (PhD), a University of Victoria biochemistry and microbiology professor emeritus who now heads reagent developer Vancouver Island Antibodies (VIA), said he tried for more than a year to get a Covid-19 patient blood sample without success.

“In fact, I couldn’t tell you how to get a sample, even one sample, in Canada to this day,” Pearson told Research Money.

He sought patient blood samples to develop a Covid-19 diagnostic test. He eventually obtained samples, in conjunction with a related U.S.-based company, SISCAPA Assay Technologies (SAT), of which he is a co-founder and director, through a consortium of European hospital-based research labs.

The test, which is also applicable to other diseases, has since proven to be highly successful and is being deployed by a European research consortium, allowing VIA and SAT to expand.

“You can have a perfect test, but you can’t get samples because there’s either no informed consent from the patient to use [a sample] for your technology, or you just can’t find them,” said Pearson. “And, in the case of Covid in Canada, I can’t find them.”

He said greater access to biological samples and patient data is needed to help deal with future pandemics.

“I’d really like to see a closer co-ordination between the clinical needs and the dreamers, who are the researchers,” said Pearson.

Dearth of annotated samples

There is a dearth of annotated samples, he added, because some patients are motivated to provide samples over time and others are not. Big pharmaceutical companies have large collections of samples but are reluctant to share because they want to use them for their own purposes.

Nor are commercial labs interested in sharing samples and data, he contended, because they have a monopoly and want to use their existing systems.

“They kill any competitors," said Pearson. "They just don’t want to hear about it,”

He has found his experience “not very fruitful” and “frustrating” because Canada has world-class medical and scientific knowledge.

“There’s no question about the scientific or medical expertise in Canada,” said Pearson. “But there’s no co-ordination between the researchers and the clinical types in the diagnostic field at all. We don’t know what each other is doing.”

Other research could benefit

Wider access to patient biological samples and data would also help researchers and technology developers seeking solutions to cancer, Alzheimer’s and Huntington diseases, and other maladies, he asserted.

One governing body for the various diseases would be too complex, he contended, but there has to be a way to “disseminate and hold, or at least co-ordinate a system where people can find samples.”

Patient privacy is at little risk of being breached, because clinic trials are double-blinded and patients remain anonymous.

“So privacy? I think it’s well-handled these days,” said Pearson. “I think the biggest roadblock is just getting the sample sets. Where are they? Who’s got the right sample set to work on?”

Pandemic spells different circumstances

Dr. Yann Joly (PhD) is a McGill professor who specializes in law and ethics and co-chairs the Global Alliance for Genomics and Health’s legal and ethical stream and chairs Genome Canada’s data-sharing group. He said the pandemic spelled a different context than usual bio-banking efforts, because sample collectors had to take many safety precautions and patients often arrived unconscious and unable to give consent.

The situation was like “learning to fly the plane and pilot [it] at the same time.” Researchers had to make up for lost time by developing processes whereby specimens could be collected quickly and data could be shared at the same time.

He said it is important to distinguish between access to samples and access to data. Access to samples is more complicated, he said, because centres that collect specimens, such as blood samples, will usually want to hang on to them and grant access to genetic information.

“There’s two steps, basically,” he said. “There’s the collection step and there’s the sharing step. So the collection step is usually, actually, not too complicated because there’s protocols in place and people follow their protocols. And then, of course, you need to sequence the information, which means that you need to have some kind of technological capacity to do that and know how [to do that].

But sharing is more challenging, he added, since it requires advance planning that often does not take place, such as determining how information will be shared and securing permission to do so. Ownership of sample and other aspects, such as the development of intellectual property, must also be sorted out. "We have to try to understand retrospectively how the information was collected, what kind of information was given to patients, how confidential the data is — all sorts of things before we can determine if it can be shared.”

In addition to permission from participants, the ability to share information may be affected by the research ethics board permission that was originally obtained for the work.

“What we want to make sure mainly is that the patient’s confidentiality is protected, and that the person using the data is really a researcher that’s going to use it in the context of a research project that’s obtained ethical approval,” said Joly.

Covid-19 patient data sharing was a challenge, he said, because a lot of information was collected by various public health labs across Canada rather than research facilities. Public health lab operators did not know as much as they should have about sharing data, and they were not familiar with its use for research purposes, he added.

“They were quite interested in using it [to understand Covid-19 variants], but it became really complicated to convince them that, yes, but this is not data just to do as you please,” said Joly. “It also needs to be shared with the research community because there’s great benefit in doing that.”

Researchers call for leadership

During Research Money’s 21st annual conference in early May, a health research panel called for action based on lessons learned about data sharing during the pandemic.

Dr. Kimberlyn McGrail (PhD), a Professor in the UBC School of Population and Public Health and Scientific Director of Population Data BC and Health Data Research Network Canada, said it is important to start from the view that the purpose is not to share data, but to use data in a meaningful way.

She said the unleashing of more data can help improve inefficiencies and inequities and improve healthcare of marginalized groups such as Indigenous groups. And, wider data sharing can improve health research at the local, provincial, national, and international levels.

But Canadian researchers are largely required to buy large data sets from other countries.

Roxana Sultan, chief data officer and vice-president of health at the Vector Institute, said the pandemic has really shown health data’s ability to drive innovation in areas of discovery, such as vaccine and drug development. In turn, the pandemic has also positively impacted related industries, helping Canada become a leader, “not a library” in the knowledge economy.

Noting that data use has exploded, Rob Annan, president and CEO of Genome Canada, said more than scientific innovation is needed. He insisted that systemic barriers must be overcome.

Annan worked with Genome Canada’s Canadian Covid-19 Genomics Network (CanCOGen), with which Joly was also involved, on the sequencing of coronavirus data. He found that the biggest challenges to sharing data were cultural rather than technical or financial, and suggested that leadership was lacking at the national level.

He, McGrail and Sultan are anxious to see how the federal government will follow up on the Pan-Canadian Health Data Expert Advisory Group (EAG) final report, Pan-Canadian Health Data Strategy: Toward a world-class health data system, and advance the development of a nationwide health data strategy, and ultimately a Canadian health data charter.

Patients happy to share data

Joly noted Canada was initially unable to meet its requirement to share its Covid-19 data globally. Nevertheless, most patients are quite happy to share their data for health research if they know their personal information is protected, “but they need to be asked.”

He called for Canadian laws and policies to be revised to make data sharing more efficient and the process less bureaucratic and arbitrary — so that one entity does not have the freedom to block information-sharing that would benefit public health.

“The whole point in the pandemic is that we ended up sharing the data but it took us about a year in order to get a machine to run smoothly to share the data, basically,” he said. “But a year is a huge amount of time in the pandemic. So you want to be able to do that right from the get-go next time, and that’s where we really need to fine-tune our policies and our laws — so that we are well prepared next time.”

Read: Championing a charter to facilitate health data sharing

By Lindsay Borthwick

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