
==== Front
JCO Precis Oncol
JCO Precis Oncol
po
PO
JCO Precision Oncology
2473-4284
Wolters Kluwer Health

39116357
PO.24.00184
10.1200/PO.24.00184
00189
ORIGINAL REPORTS
Precision Medicine
“I Just Assumed This Was Already Being Done”: Canadian Patient Preferences for Enhanced Data Sharing for Precision Oncology
https://orcid.org/0000-0002-3070-2092
Pollard Samantha PhD 1 2
https://orcid.org/0000-0002-0343-7115
Ehman Morgan MPH 1
https://orcid.org/0000-0002-9836-5205
Hermansen Anna MSc 1 3
https://orcid.org/0000-0002-3072-5657
Weymann Deirdre MA 1 2
https://orcid.org/0000-0002-6590-8728
Krebs Emanuel MA 1
https://orcid.org/0000-0002-5922-3984
Ho Cheryl MD 4 5
https://orcid.org/0000-0002-5814-714X
Lim Howard J. MD, PhD 4 5
https://orcid.org/0000-0003-3394-2208
Jones Steven PhD 6 7
https://orcid.org/0000-0002-9516-4539
Bombard Yvonne PhD 8 9
https://orcid.org/0000-0003-3228-6042
Hanna Timothy P. MD, PhD 10 11
Hessels Chiquita 12
https://orcid.org/0000-0002-1662-0832
Longstaff Holly PhD 13
https://orcid.org/0000-0002-8251-4237
Cook-Deegan Robert PhD 14
Bubela Tania PhD 2
https://orcid.org/0000-0001-8876-0511
Regier Dean A. PhD 1 3
1 Cancer Control Research, BC Cancer Research Institute, Vancouver, BC, Canada
2 Faculty of Health Sciences, Simon Fraser University, Burnaby, BC, Canada
3 School of Population and Public Health, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada
4 Department of Medical Oncology, BC Cancer, Vancouver, BC, Canada
5 Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada
6 Canada's Michael Smith Genome Sciences Centre, BC Cancer, Vancouver, BC, Canada
7 Department of Medical Genetics, University of British Columbia, Vancouver, BC, Canada
8 Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada
9 Genomics Health Services Research Program, Li Ka Shing Knowledge Institute of St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada
10 Department of Oncology, Queen's University, Kingston, ON, Canada
11 Department of Public Health Science, Queen's University, Kingston, ON, Canada
12 Li-Fraumeni Syndrome Association Canada, British Columbia, Canada
13 Provincial Health Services Authority, Vancouver, BC, Canada
14 Arizona State University, Washington, DC
Dean A. Regier, PhD; e-mail: dregier@bccrc.ca.
2024
08 8 2024
08 8 2024
8 e240018418 3 2024
2 5 2024
11 6 2024
© 2024 by American Society of Clinical Oncology
2024
American Society of Clinical Oncology
https://creativecommons.org/licenses/by-nc-nd/4.0/ Creative Commons Attribution Non-Commercial No Derivatives 4.0 License: http://creativecommons.org/licenses/by-nc-nd/4.0/

PURPOSE

In Canada, health data are siloed, slowing bioinnovation and evidence generation for personalized cancer care. Secured data-sharing platforms (SDSPs) can enable data analysis across silos through rapid concatenation across trial and real-world settings and timely researcher access. To motivate patient participation and trust in research, it is critical to ensure that SDSP design and oversight align with patients' values and address their concerns. We sought to qualitatively characterize patient preferences for the design of a pan-Canadian SDSP.

METHODS

Between January 2022 and July 2023, we conducted pan-Canadian virtual focus groups with individuals who had a personal history of cancer. Following each focus group, participants were invited to provide feedback on early-phase analysis results via a member-checking survey. Three trained qualitative researchers analyzed data using thematic analysis.

RESULTS

Twenty-eight individuals participated across five focus groups. Four focus groups were conducted in English and one in French. Thematic analysis generated two major and five minor themes. Analytic themes spanned personal and population implications of data sharing and willingness to manage perceived risks. Participants were supportive of increasing access to health data for precision oncology research, while voicing concerns about unintended data use, reidentification, and inequitable access to costly therapeutics. To mitigate perceived risks, participants highlighted the value of data access oversight and governance and informational transparency.

CONCLUSION

Strategies for secured data sharing should anticipate and mitigate the risks that patients perceive. Participants supported enhancing timely research capability while ensuring safeguards to protect patient autonomy and privacy. Our study informs the development of data-governance and data-sharing frameworks that integrate real-world and trial data, informed by evidence from direct patient input.

@CLEONetwork researchers identify patient priorities for enhanced precision oncology data sharing initiatives

OPEN-ACCESSTRUE
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pmcINTRODUCTION

Precision oncology relies on genomic sequencing to generate large-scale, annotated ‘omics data. Such data leads to insights about cancer pathophysiology and prediction about variant pathogenicity, treatment response, resistance, quality of life, and side effects when combined with other data generated within learning health systems.1,2 Systematic challenges in data collection, access, and use in Canada are magnified for precision oncology, owing to the volume of data generated, and the need to integrate ‘omics, clinical data, and other real-world data (RWD) sources. Current evidence development is hindered by small patient numbers, single-arm trials that are insufficient to establish comparative effectiveness, and dated or biased effect estimates.1,3 Life cycle real-world evidence (RWE) on the basis of RWD has been proposed to address evidentiary challenges.1

CONTEXT

Key Objective

How can secured data-sharing platforms be developed and implemented in a manner that directly acknowledges and responds to patient values, expectations, and concerns for enhanced precision oncology research?

Knowledge Generated

Through a series of five pan-Canadian focus groups with individuals with lived and living experience of cancer, we found that participants were highly motivated to broaden data sharing across Canada to support and expand the impact of precision oncology research. Alongside support, participants prioritized the establishment of data access and sharing oversight committees, privacy and confidentiality protection, and nimble consent frameworks that respect individual risk tolerance.

Relevance

Our work will help guide current and future initiatives seeking to expand data collection, sharing, and researcher access to enable precision oncology innovation and evaluation.

Without data integration and RWE of patient benefit, innovation will continue to outpace therapeutic development, safe and effective implementation, and evaluation.4 However, in Canada, data are siloed within and between provincial and territorial health systems, hampering research access, data concatenation, and analysis. Furthermore, randomized clinical trials are lacking as a result of small benefitting patient numbers and challenges associated with timely patient accrual.5,6 Data siloing impedes the use of RWD to augment sample sizes and aid data collection for clinical and economic evidence development, as well as regulatory, reimbursement, and policy decisions.7,8

Privacy-preserving secured data-sharing platforms (SDSPs) may aid in de-siloing data, enabling cross-jurisdictional analysis.9 Iterative integration of RWD and trial data into SDSPs, combined with federated learning across SDSPs, can support timely and comprehensive evidence development.1,10 The term “sharing” is shorthand for data collection, storage, access, and use, but federated systems do not require data to physically move between physical data storage sites. Before SDSPs can be implemented to support urgently needed research evidence generation, their design and governance must reflect the needs, preferences, and concerns of those whose data populate such platforms.11,12

Published evidence finds that individuals are able to rationally consider and weigh risks and benefits of sharing electronic medical records, clinical information, and genetic data.13,14 Many support data sharing but express concerns about privacy and misuse by untrustworthy or profit-driven entities.11,15-19 It is timely to understand patient preferences for control, that is, with whom data are shared and whether and how genomic results are returned. The latter may impact personal or family health care, incentives to enable access to data, and use of data for population health benefit.

Absent from the evidence base is a clear understanding of the breadth of concerns and expectations related to the development and governance of a pan-Canadian SDSP for precision oncology. Furthermore, recommendations to inform the interface and design of patient-facing elements of such a platform are urgently needed, alongside ongoing international and national efforts to generate SDSPs. We aimed to qualitatively elicit patient preferences for data governance, control, and researcher access to precision oncology data across Canadian health systems. Reporting of this work aligns with consolidated criteria for reporting qualitative research guidelines.20 This research was approved by the BC Cancer University of British Columbia Ethics Board (H20-00861).

METHODS

All study documentation was developed through an iterative process of literature review and co-creation alongside the CLEO working group. A description of the multidisciplinary working group and the development of focus group materials and member checking surveys are provided in the Data Supplement.

Focus Group Process

Eligible participants were adults residing in Canada, with a history of cancer. Participants were purposively sampled using a study advertisement posted across online community boards (eg, Kijiji, Craigslist), patient groups (eg, Facebook), and organizations linking patients with research opportunities.13 To enhance diversity in British Columbia, oncologists provided study information to patients in their clinics at BC Cancer, Vancouver. Interested participants completed a screener to confirm eligibility. Eligible participants completed an online consent form via REDCap.14

We held focus groups on Zoom. Two trained female qualitative researchers (S.P. and A.H.) facilitated English-language focus groups and a trained male team member (E.K.) facilitated the French-language focus group. Facilitators introduced themselves and team observers, followed by a brief presentation describing research objectives, session structure, and discussion topics. Following focus groups, participants completed a demographic questionnaire via REDCap and were provided an honorarium of CA$100.

Analytic Approach

We concurrently collected and analyzed data. Analysis began with note-taking during focus groups.21 Once professionally transcribed, translated (French focus group), deidentified, and validated against audio-recordings, three analysts conducted open coding and developed the coding framework.22 Three analysts (S.P., A.H., and M.E.) coded the transcripts using QSR NVivo Software.23 The analytic code book was developed through an iterative approach involving the a priori selection of deductive codes on the basis of their relevance to the primary research questions. Deductive codes included those relating to consent and SDSP design. Remaining codes were identified inductively.22 Analysts then applied the codebook to subsequent transcripts. Throughout recruitment, focus group completion, analytic memo taking, and review of transcripts, two analysts (S.P. and A.H.) developed the final coding framework, detailed in the Data Supplement.

Analysts iteratively developed analytic themes by comparing codes and memos against new data to combine, collapse, and modify.21 Analysts collectively determined when no further focus groups were required based on agreement that no new perspectives across themes were identified.13 To ensure transparent synthesis of discussions, we finalized analytic themes after member-checking. Finally, two analysts (S.P. and M.E.) summarized preferences for SDSP design and features.

RESULTS

Table 1 describes participant characteristics.

TABLE 1. Participant Characteristics

Characteristic	No. (%)	
Sex (n = 27)		
 Female, No. (%)	19 (70)	
Age (n = 27)		
 Median (range)	59.5 (22-85)	
Province (n = 27), No. (%)		
 British Columbia	8 (30)	
 Prairies (Alberta, Saskatchewan, Manitoba)	5 (19)	
 Ontario	8 (30)	
 Quebec	6 (22)	
Racial/cultural group (n = 27), No. (%)		
 White	20 (74)	
 East Asian	4 (16)	
 Southeast Asian	1 (4)	
 Filipino	1 (4)	
 Missing	1 (4)	
Education (n = 27), No. (%)		
 Bachelor's or above	14 (52)	
 Diploma	4 (15)	
 University, below bachelor's	4 (15)	
 High school	1 (4)	
 Apprenticeship or trades certificate	3 (11)	
 Prefer not to answer	1 (4)	
Previous genetic testing, No. (%)	11 (41)	
Experience with cancer, No. (%)		
 Previous diagnosis	12 (44)	
 Current diagnosis, undergoing treatment	9 (33)	
 Current diagnosis, not undergoing treatment	4 (15)	
 Missing	1 (4)	
 Prefer not to answer	1 (4)	
Cancer type,a No. (%)		
 Breast	9 (33)	
 Uterine or endometrial or cervix or ovarian or “female cancer”	6 (22)	
 Lung	4 (15)	
 Prostate	3 (11)	
 Melanoma	2 (7)	
 Gastric	2 (7)	
 Other: bone, thyroid, duodenum, chronic lymphocytic leukemia, bladder	5 (19)	
a Categories are not mutually exclusive.

Ten participants completed member-checking surveys. Participants responded favorably to summaries of discussion points presented within each survey. Specifically, participants used open-ended feedback questions to reaffirm their attitudes as consistent with those included in the summaries. For example, “…for the most part what was present here is accurate. Having been on both sides of the equation both a cancer patient and cancer treatment service provider, I see the value of establishing an enhanced data sharing model” (MC1), and “My recollection is consistent with your summary. Most participants strongly favoured sharing data to help greater good, provided controls in place to protect personal data” (MC2).

Critical feedback stressed the importance of highlighting preference heterogeneity across discussions. Participants highlighted issues and opinions raised by other individuals, such as, “at least one participant didn't seem particularly worried about the anonymity of the data, but the majority were certainly in favour of it” (MC3). Similarly, one participant noted that “participant[s] ha[d] different preference[s] for the way of sharing data (eg, some may allow sharing data to everyone, but some wants to restrict data sharing… prohibited to insurance company, etc)” (MC4). Direct participant quotes are illustrated in Table 2.

TABLE 2. Participant Quotes

Analytic Theme	Number	Focus Group Direct Participant Quote	
Initial impressions	1	“I was a little surprised to know that it was so siloed and the information was not easily shared within our own borders.” (CANFG-P17)	
2	“I am very concerned about the fact that here in Canada we don't share [what] we have.” (QCFG-P22)	
3	“I didn't realize that that [data sharing across provinces] wasn't happening at this point, that it was only by province. Anything to increase better treatments I'm all for and I've always said too that I want to share my information if it can help others or help research in some way. And I don't need a financial incentive….” (CANFG-P19)	
Willingness to manage perceived risk	4	“If I have two children sharing my genetic makeup, and I have a disease, that can be used to help children like this in the future so they don't get as sick as I was, or maybe don't get sick at all, as a result of me sharing the information. I think it overwhelmingly goes into area where human life is way more important than a mortgage….” (BCFG-P7)	
5	“I'm okay to have it shared with certain—as long as it's to the benefit of the patient. I have concerns as well with insurance companies because I know there's always the struggle to be covered, whether it be short-term or long-term disability. And anything they find, even the smallest thing that they can avoid covering you for, it happens.” (CAN2FG P2)	
Oversight and regulation	6	“I personally don't need to know the researcher or what they're doing with it. But what I'm more concerned with is the oversight of it. Has it been vetted properly, this is something legitimate by a group of well-known, established people… and then entrust them with that, that they're going to do the right thing.” (CANFG-P18)	
	7	“Having patient voice involvement in a consent process, in a writing up of a consent process, and then saying at the end this consent page or document was done in conjunction with patient voice, for me, would make me feel like there was just another level of care and concern brought from minute one.” (CANFG-P20)	
Autonomy and connectedness	8	“I agree with the patient representation, because a lot of times you get a consent—no matter where it's from, if you think about how consents work, they kind of crack me up. Because a lot of times no matter what you're getting, even if it's a new phone, it's like, ‘Sign this consent. If you don't sign it, you don't get the service.’ So it's not even like it's an option half the time.” (CAN2FG-P2)	
9	“If my data is shared and then I would want to see a traceability report on it or something. How is my data shared, how is it being used might be pertinent… Maybe a yearly report.” (ONFG-P10)	
Informational transparency	10	“… when someone makes a request to access the data, I think they should specify what the data will be used for, how long it will be kept, where it will be kept, and whether they will be sharing that data to any third parties. Because I, personally, I don't want the data to be sold to some other, like, company or third party without me knowing.” (QCFG-P9)	
11	“I'm uneasy about pharmaceutical companies and I'd like them to explain what they want to do with this information.” (QCFG-P5)	
Navigating personal and population implications	12	“It's very important for researchers to have access to data—or more data, such as all population studies. This is very important for public health policies as well as for developing drugs, for example, to treat rare cancers.” (QCFG-P2)	
13	“I'm highly motivated because the more information that's out there, especially if it's something rare, the more information the researchers have, the more that can be done, and et cetera. We need to get the information out there, not have it hidden between provinces… it needs to all be open so we have all the information to get the cure, to get the treatment.” (CAN2FG-P2)	
Weighing risk and benefits	14	“that would be my only concern really with sharing, is… the information getting into somebody's hands that is not—doesn't have the best interests in mind…” (CANFG-P19)	
15	“I'm not against sharing my data, in fact I'm really in favour of that. But I'm hoping it's going to be anonymized or the aggregated data is going to be shared for generalized treatment.” (BCFG-P5)	
16	“what if there's a breakthrough in lung cancer and now you have all these unidentified people… you can't reach them now. What if there's a vaccine that's come along that would help people who've had A, B, C cancer and who had A, B, C treatment, now you can't reach them? So I understand the unidentified, but if it's non-reversible, I'm not sure how helpful that is….” (CAN2FG-P1)	
Reciprocity	17	“Speaking about incentives, I don't need an incentive to participate in this. The—it's the realization that I'm helping people and that it actually might benefit me down the road. This is how we make progress with cancer control is having solid research behind us and if sharing data does that, that's all I need for incentives.” (CANFG-P18)	
18	“I think a for-profit research company could—how can I say this? They can offer incentives. If they're a for-profit company, pharmaceutical, they can offer incentives or pay into a system to get the information.” (CAN2FG-P2)	
19	“I don't know if this would bring about, like, ethical concerns, but I probably wouldn't be against offered—being offered like a lump sum of money. I think that there are reasons why that isn't, like, more popular just because it would kind of exploit marginalized populations, I guess. But I think that that would definitely motivate me to share if they were like here's a little money incentive.” (CANFG-P11)	
20	“So, I think it sort of sounds like buying data, like you're offering money to buy your data. And obviously I think it would definitely entice a lot of people to want to share the data depending on, like, the monetary amount. But I just don't think it's the right approach because I think you should share your data when you feel comfortable sharing it.” (ONFG-P9)	
21	“I'm not too keen on the monetary reward. But I think if patients are inconvenienced, if you are to travel to a certain place, if you're asked to be there for several hours, or continue on for months to be answering certain things, yes.” (ONFG-P13)	
22	“It would be good to offer to pay patients to complete a lifestyle questionnaire every month or twice a year. That will certainly speed up the research. I think it's a good idea to consider that.” (QCFG-P2)	

Thematic Analysis

Following integration of member-checking feedback into the preliminary analysis, two analysts (S.P. and M.E.) refined analytic themes. Participants were highly motivated to enhance data sharing across Canada for oncology research, indeed many “just assumed this was already being done” (BCFG-P2). They discussed preferences, expectations, and concerns alongside harms, expected benefits, and hope to mitigate risks while expediting evidence generation. Underscoring urgency, many participants used terms like “surprised” and “concerned,” that current policies hamper pan-Canadian data sharing (Quotes [Q] 1-3; Table 2).

Two major themes and five minor themes were identified through our analysis (Table 3). Theme 1, “Willingness to manage perceived risk,” describes processes to mitigate risks arising from perceived harms. Theme 2, “Navigating personal and population implications,” describes expectations for contributing data, grounded in tensions between collective benefit and personal protection.

TABLE 3. Analytic Themes

(1) Willingness to manage perceived risk: Strategies to support enhanced data sharing while acknowledging the potential for data breaches, unintended secondary use of data, the development of cost-prohibitive treatments, and treatments with limited patient access	
 Oversight and regulation: Established data-governance structures, mediation, and limiting access requests to only required data elements to support the proposed research, as mechanisms to enhance trust and mitigate risk perceptions. Risk mitigation strategies discussed included: review committees, patient involvement, and established processes for researchers requesting access to individual patient level data	
 Autonomy and connectedness: Preservation of individual patient autonomy and identity within research initiatives, from data access to receipt of research outputs (eg, treatment access). Notably, participants discussed flexibility in terms of what data could be shared (eg, dynamic consent) and withdrawal of consent	
 Informational transparency: Clear and transparent communication about research access and anticipated research outcomes as a means to ensure meaningful connectedness with research. Subtheme defined by variation in perspectives regarding the level of information that should be relayed to potential platform participants	
(2) Navigating personal and population implications of secured data sharing: Underlying value to support oncology research initiatives while mitigating the potential for harm and ensuring appropriate treatment of shared data	
 Weighing risk and benefits: Acknowledgment there is some personal risk involved (data hacking, data breaches, unintended access/use, discrimination), alongside the belief that potential benefit outweighs risks, if efforts are made to mitigate risks	
 Reciprocity: Expectation and motivation to allow personal health data to be shared for the purposes of collective benefit of cancer patients (eg, treatment development and better therapeutic alignment)	

Willingness to Manage Perceived Risk

Oversight and Regulation

Participants discussed ways to manage data sharing and security through consent processes and data oversight committees tasked with approving requests and setting bounds around permissible research (Q6). For example, some participants wanted data oversight bodies to determine “has it been vetted properly, this is something legitimate by a group of well-known, established people” (Q6) without being directive about committee membership.

Perceived risk was tempered when considering oversight committees to ensure appropriate and valued research, particularly if embedded within academic contexts already benefiting from research ethics monitoring. In one focus group, participants built on this idea and discussed the role of patients in informing oversight makeup and procedures, agreeing that committees inclusive of patients would enhance trustworthiness of an SDSP, demonstrating “another level of care and concern brought from minute one”(Q7). Participants often reflected on personal experiences navigating lengthy and opaque consent processes, suggesting oversight could further alleviate participant informational burden and enhance trust in research.

Autonomy and Connectedness

Participants consistently valued meaningful patient involvement across the research trajectory. Support for involvement spanned co-development and design of oversight structures, research study and data request documentation, and policies around who may request data access and for which purposes. While individual preferences varied, participants aligned in that patient and public voices should inform future data-sharing procedures and oversight, with an overarching view that data must be shared for the purposes of improving patient health and health care access.

Participant suggestions about how to engage patients throughout the request and research trajectory included having patients co-develop data-sharing consent forms and agreements (Q8), notifying participants about how their data were used (Q9), and providing access to aggregate results and individually relevant treatments. Some participants criticized the coercive nature of standard consent forms both within and external to health care settings. One participant noted that “they kind of crack me up. Because a lot of times no matter what you're getting, if you don't sign it, you don't get the service” (Q8). While participants varied in terms of their own preferred level of control, they recognized the personal nature of this decision and supported nimble or dynamic consent frameworks enabling individual patient control over access and use.

Informational Transparency

Participants persistently stressed the need for transparent communication about data use and anticipated outcomes, for example, “what the data will be used for, how long it will be kept, where it will be kept, and whether they will be sharing that data to any third parties” (Q10). While preferences varied in terms of the level of detail required to provide consent, participants valued transparent reporting (eg, “a traceability report” [Q9]) about intended or actual use of data with the option to receive additional information (Q10). Informational transparency was thought to enhance trust by vetting the trustworthiness of data requestors (Q11).

Although skeptical of for-profit access to health data, participants were willing to participate in such initiatives driven or funded by private industry, premised on meaningfully informed consent and transparent information transfer, as described above (Q10). In comparison with discussions related to academic use of data, participants discussing for-profit research cited a need for detailed information before consent, strict bounds around use and storage of data, and a clear reporting of how research outputs would be disseminated. Underlying this preference was persistent questioning of whether private-funded research would be motivated by financial benefit rather than improved patient health.

Navigating Personal and Population Implications

Weighing Risks and Benefits

Participants recognized that enhanced data access raised personal risks for themselves and family members (Q14), while articulating tensions between risk and expectations of personal and collective benefit. Participants weighed risks associated with data misuse against a strong motivation to ensure the availability of data required for improved diagnostics, treatments, and improved survival. For example, some participants considered whether data should be completely anonymized, or reversibly deidentified (Q15).

Despite concerns about identifiability and privacy, participants supported the return of aggregate study findings and tangible benefits to patients. With the inability to return individually relevant findings to patients whose data are irreversibly anonymized, one participant wondered “if it's non-reversible, I'm not sure how helpful that is” (Q16). Perspectives on deidentification and reidentification varied, with agreement that researchers should not access identifiable data, at a minimum. Most participants stressed the importance of receiving individually relevant study findings that could affect them or their family, requiring de-identification rather than irreversible anonymization of data.

Reciprocity

Participants often referenced their personal cancer journeys when discussing motivations to enhance data sharing. Participants were generous in offering personal stories, including barriers to accessing appropriate and timely treatments and personal motivations. Individual experiences frequently framed discussions about expectations of collective benefit, noting “this is how we make progress with cancer control” (Q17). While some participants spoke about motivation to participate in research with the expectation of personal benefit, most were motivated by collective benefit for future patients. Beyond access to research outputs, participants considered remuneration in exchange for data. In one focus group, participants recommended that pharmaceutical companies pay for data by paying data custodians (Q18).

While some participants were willing to accept financial compensation in exchange for their personal health data (Q19), many were concerned about coercion, citing that a patient should share “when you feel comfortable sharing it” rather than being motivated by remuneration (Q20). Participants were more supportive of remuneration when considering invasive or prospectively collected data. For example, participants favored reimbursement for travel time to attend clinic visits or to “complete a lifestyle questionnaire every month or twice a year” as a means to “speed up the research” and value participant contributions (Q21 and Q22).

Platform Features

Cutting across themes, participants discussed granular aspects of SDSP design, interface, and optional features facilitating greater connectedness with the research and study findings. Notably, participants stressed the importance of ensuring the platform interface meets the needs of those with varying degrees of risk tolerance, informational curiosity, and engagement with the research process and outputs (Table 4).

TABLE 4. Recommended SDSP Design Elements

SDSP Component	Suggested Design Element to Mitigate Perceive Barriers	Illustrative Quote	
Interface	Simple navigation throughout platform that can be easily used by a wide demographic of patients (eg, low literacy, multiple languages, elderly)	“The home page must be very simple, with different icons we can easily click on to navigate around the platform, so it's simple and visual, so we don't get lost. Because the best apps are those that are simple and also have colours to attract our attention.” (QCFG-P5)	
Access requests	A feature that answers patient's questions regarding granting access to data requestor	“… What's the project? What will you do with my data? These are all the questions I have about the degree of security being provided that I would. Finally, there someone specific or a supervisor of this platform we can contact to ask questions if we are concerned about a request or have questions.” (FRFG-P1)	
Access requests	Ability to access more detailed information about data requestor, data being requested, and proposed use of data	But maybe there could be a link beside a certain area that we could click to have further information if we wanted to read more about exactly what that person is doing with the information. Like an overview but then maybe a link that spells it out if we want more detail on where our information is going. (ONFG-P14)	
Consent	Ability to revise and withdraw consent	“… the systems should be very dynamic to allow everyone have their own decision at different time and different situations. … Because you might say yes today, but you might change your mind tomorrow.” (BCFG-P8)	
Data access	Notifications about who is requesting, accessing, and for what purposes	“Anybody who accesses my data, I'm notified. Basically, ‘I'm accessing Participant 10's data, I'm going to use it here for this reason, and blah, blah, blah,’ and that's now attached to my file and, bing, it sends an email to me….” (ONFG-P10)	
Return of information	Notifications about how the individual's data were used	“If my data is shared and then I would want to see a traceability report on it or something. How is my data shared, how is it being used… Maybe a yearly report, did my data get used anywhere….” (ONFG-P10)	
Return of information	Notifications about results of any studies conducted using the individual's data	“… if I'm going to get back something that, ‘Thank you for contributing to this. From your information and others we were able to…’ The fact that you were able to make this a better place is very positive and you'll get more input.” (ONFG-P13)	
Abbreviation: SDSP, secured data-sharing platform.

Valued features further included respect for variation in preferences, the ability to update consent and view information about requestors, and to receive aggregate study results. Underpinning participant recommendations, participants prioritized a design that would appeal to patient and public informational needs. In this sense, there was a collective motivation to encourage data sharing, while ensuring that potential SDSP participants are truly informed in their consent, have ample opportunity to have concerns addressed in advance of consent, and are free from coercion in allowing their data to be used to support valued research endeavors.

DISCUSSION

Siloed genomic, clinical, and health system data are impeding evidence generation for precision oncology technology development, evaluation, and patient access. Pan-Canadian SDSPs are one solution, the acceptability of which we interrogated using focus groups. Multiple efforts are ongoing to enhance cross-jurisdictional data sharing, including by Health Canada, the Terry Fox Marathon of Hope Cancer Centres Network,24 Canada Health Infoway,25 Health Data Research Network Canada,26 the UK Biobank,27 and the All of Us research program in the United States.28 Our findings provide important patient perspectives on preferences for data governance, control, and researcher access to data that can be used to operationalize patient-driven data oversight and governance frameworks within and beyond ongoing national and international data-sharing initiatives.

Across focus groups, participants were highly and personally motivated to enhance cross-jurisdictional data availability through SDSPs, while navigating tensions between sharing capacity and protection of patient privacy and security. Indeed, several participants were surprised that data remain siloed, hampering research access and timely innovation. Preferences for control were premised on expectations of informational transparency and future benefit. Similarly, participants valued informed consent responsive to individual preferences for information related to data use and the return of findings as critical to empower decision making. Perceived barriers to participation centered on misuse and limited access to research outputs. Select findings are consistent with published evidence characterizing patient and public values for enhancing data sharing for health research, further stressing the need for patient autonomy and protection as central to infrastructure and governance.11,12,15,18,29 We build on published evidence to generate SDSP interface features to promote research participation grounded in meaningfully and nimble informed consent. Our findings reject a one-size-fits-all approach, rather prospective consent structures are required to reflect individual patient values and concerns.

While participants did not consistently prefer financial remuneration in exchange for data, they valued benefit in the form of study findings and access to treatments, while acknowledging that incentivizing research participation may encourage recruitment and expedite development of large research databases. Similarly, participants did not wholly oppose sharing data with private industry, “as long as it's to the benefit of the patient” (Q5), but sought enhanced safeguards through secure data storage and assurance that data would be used as intended. While some voiced ambivalence toward for-profit research, others who were averse recognized the important role that industry plays in drug development. Such participants focused their discussions on what would be required to overcome such aversions to grant private industry access. Building off previous investigations reporting hesitation to share data with private industry,29 our work contributes to a better understanding about what underpins public aversion to for-profit research, namely, the prioritization of profit over patient health and access.

As demonstrated by this work, willingness to engage with data sharing and large-scale, pan-jurisdictional ‘omics research initiatives are premised on and hampered by perceived trust in institutions, processes, and policies. Results suggest the need for efforts to establish trusted oversight in a manner that reflects patient priorities and concerns. What is now needed is a transparent process to determine the makeup of such committees, how members are appointed, how to navigate the balance of power between technical experts and patient members, and who can represent patient and public voices to ensure that data access approvals appropriately balance research access with privacy and security considerations. With ongoing efforts to enhance data-sharing capacity and infrastructure, such initiatives are well-positioned to begin these conversations in consultation with patients and members of the public.

Our findings illustrate strong patient appetite to reduce data silos and establish sharing procedures defined by responsiveness to variable risk tolerance. Alongside frustrations by siloed data storage hampering timely evidence generation, participants call for robust oversight enabling precision oncology innovation. As demonstrated here, doing so requires early and ongoing patient engagement to ensure that technical and governance solutions adequately respond to preferences. While participants were nonprescriptive about consent and data-governance models, proposed solutions point to nimble approaches that place individual risk tolerance at their forefront, as a prerequisite to public trust in bioinnovation.

This work should be interpreted considering limitations. First, our sample was limited in terms of demographic diversity, with most participants self-reporting white and female. However, the qualitative investigation reported here does not seek to generate findings that are generalizable. Rather, we endeavored to prioritize richness of information gathered and diversity of perspectives, by applying a purposive sampling technique.30,31 Our sample achieved a diversity of perspectives on regions, age, cancer types, and treatment stage, but lacked diversity on gender and ethnicity. Future qualitative research investigations with access to other patient populations and perspectives are needed to address this limitation. While costly and subject to selection bias, recruiting using a market research firm may have assisted in efforts to enhance diversity of focus group participants.

Second, only 10 member-checking surveys were returned and incorporated into the final thematic analysis. Surveys required ethical approval after the focus groups took place, resulting in administrative delays. Participants may have been unable or unwilling to recall detailed discussions. Finally, owing to resource and time constraints, member-checking surveys were administered only to English-language participants, limiting feedback from French-speaking participants into the final analysis. For this reason, feedback may not reflect the spectrum of sentiments or opinions held by all participants. Future investigations incorporating member-checking may benefit from faster turnaround time in circulating surveys, to ensure participants are willing and able to provide follow-up feedback to guide interpretation of research findings.

In conclusion, RWE for precision oncology is premised on trust in public health infrastructure, procedures, and policies. To meet the demand of timely data access for precision oncology, transparency to enhance trust and autonomy is critical. We demonstrate motivation to shift the Canadian health research landscape to an environment of timely innovation and evidence-based implementation, alongside recommendations for patient-facing SDSP interface design. Placing patient voices and preferences at the forefront of these efforts will ensure a learning health system centered on trust and collective motivation to achieve population health benefit.

ACKNOWLEDGMENT

The authors gratefully acknowledge the contributions of the Canadian Network for Learning Healthcare Systems and Cost Effective ‘Omics Innovation's Working Group and thank each research participant for their time and valuable contributions to the focus group discussions. In addition, the authors would like to acknowledge research contributions from The Sulston Project: Making the Knowledge Commons for Interpreting Cancer Genomic Variants More Effective, US National Institutes of Health Grant R01 CA237118. T.P.H. holds a research chair provided by the Ontario Institute for Cancer Research through grant IA-035 provided by the Government of Ontario. Y.B. holds the Canada Research Chair in Genomics Health Services and Policy at the University of Toronto and Unity Health Toronto.

Finally, the authors wish to thank Dr. Erin Strumpf and Noah Merali for their assistance wth recuitment and coordination of the French-language focus group.

SUPPORT

AUTHOR CONTRIBUTIONS

Conception and design: Samantha Pollard, Morgan Ehman, Anna Hermansen, Deirdre Weymann, Cheryl Ho, Steven Jones, Yvonne Bombard, Chiquita Hessels, Robert Cook-Deegan, Tania Bubela, Dean A. Regier

Financial support: Dean A. Regier

Administrative support: Samantha Pollard, Morgan Ehman

Provision of study materials or patients: Howard J. Lim, Yvonne Bombard

Collection and assembly of data: Samantha Pollard, Morgan Ehman, Anna Hermansen, Emanuel Krebs, Howard J. Lim

Data analysis and interpretation: Samantha Pollard, Morgan Ehman, Anna Hermansen, Emanuel Krebs, Timothy P. Hanna, Holly Longstaff, Robert Cook-Deegan, Dean A. Regier

Manuscript writing: All authors

Final approval of manuscript: All authors

Accountable for all aspects of the work: All authors

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/po/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Supported by Genome British Columbia/Genome Canada (G05CHS).

Samantha Pollard

Consulting or Advisory Role: Roche, Birota Economics Group

Other Relationship: IMPRINT Research Consulting

Deirdre Weymann

Consulting or Advisory Role: Roche, Birota Economics Group

Travel, Accommodations, Expenses: Illumina

Other Relationship: IMPRINT Research Consulting

Cheryl Ho

Consulting or Advisory Role: AstraZeneca, Bristol Myers Squibb, Merck, Roche, Novartis Canada Pharmaceuticals Inc, Bayer, Amgen, Pfizer, Janssen Oncology, Jazz Pharmaceuticals, Sanofi, Sterimax

Research Funding: AstraZeneca (Inst), Roche Canada (Inst)

Howard J. Lim

Honoraria: Ipsen, Merck, Roche Canada, Eisai, Taiho Pharmaceutical, BMS Canada, AstraZeneca Canada, Amgen, Astellas Pharma, Varian Medical Systems, Dicephera Pharmaceuticals, Inc

Research Funding: Taiho Pharmaceutical (Inst), Roche (Inst)

Travel, Accommodations, Expenses: Eisai, Taiho Oncology

Steven Jones

Stock and Other Ownership Interests: Alamya Health

Patents, Royalties, Other Intellectual Property: I am an inventor on patents for discoveries that have been made as part of my employment with BC Cancer, British Columbia, Canada

Yvonne Bombard

Leadership: Genetics Adviser

Stock and Other Ownership Interests: Genetics Adviser

Speakers' Bureau: Takeda

Patents, Royalties, Other Intellectual Property: Co-Founder of Genetics Adviser

Timothy P. Hanna

Other Relationship: Ontario Health—Cancer Care Ontario Radiation Treatment Program

Robert Cook-Deegan

Other Relationship: Public Innovation Project

(OPTIONAL) Uncompensated Relationships: Public Innovation Project

Dean A. Regier

Research Funding: Roche (Inst)

No other potential conflicts of interest were reported.
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