Understanding the politics of clinical trials in a pandemic

As well as adapting the business of keeping blood flowing from donors to the patients in need, the pandemic presented Canadian Blood Services with a unique and exciting opportunity to support clinical trials to help explore a safe and effective treatment option for COVID-19 patients.

Since April 2020, and with the approval of Health Canada, both Canadian Blood Services and Héma-Québec were responsible for supplying convalescent plasma to Canadian physicians as part of several clinical trials. Convalescent plasma is collected from someone who has recovered from a virus. It contains antibodies made by the immune system in response to infection with a virus. It is believed these antibodies could be the key ingredient for a treatment to help others with the same virus. Information gathered through well-designed, large-scale clinical trails are the only way to know for sure whether convalescent plasma is truly a safe and effective treatment. As the national blood operator with the expertise and infrastructure necessary to safely collect, prepare and distribute convalescent plasma for use in trials of this size and scope, Canadian Blood Services’ role in these clinical trials was a perfect fit.

However, this is quite an unusual situation. Globally, most clinical trials are sponsored and conducted by the pharmaceutical industry rather than by the unusual partnerships that have been forged to conduct convalescent plasma trials. As with any new situation, valuable lessons can be learned by understanding the experience of the blood operators as they navigate these clinical trials, and that’s where Canadian Blood Services social scientist Dr. Kelly Holloway and her collaborators at Canadian Blood Services, the University of Toronto and Dalhousie University come in. I chatted to Kelly to learn more.

What got you interested in this topic?

I am currently doing research into our efforts to increase plasma collection in Canada. The publicity about convalescent plasma as a possible treatment for COVID-19 has raised public awareness of plasma as a possible lifesaving treatment, so I wanted to explore the implications of this trial on plasma donation in general.

I am also curious about how these donors are unique contributors to clinical trials. They are unlike the usual clinical trial participant, in that they won’t receive any treatments and already recovered from the disease. What motivates these unique donors, and what does their participation mean for the organization and governance of a clinical trial?

Finally, what does it mean for a national blood service to participate in a clinical trial? What are the challenges and opportunities for our recruitment of donor participants, our partnerships, our production of scientific evidence, our communication with donors and recipients of the product? What can we learn from this trial that can inform our participation in future clinical trials?

Why is the involvement of blood operators in clinical trials so unique and worth studying?

The majority of clinical trials taking place globally are sponsored and conducted by the pharmaceutical industry. Industry sponsorship of clinical trials can be associated with perceptions of systemic biases in the scientific literature, safety risks stemming from lack of access to proprietary data, inequities in access to patented treatments, and the unethical treatment of research participants.

The involvement of publicly funded blood collection agencies in the convalescent plasma trials represents a unique case study through which we can examine an alternative to the pharmaceutical industry. In our study, we are paying attention to the composition and nature of clinical trials partnerships and the implications of various models of clinical trials governance for public trust, research integrity and the distribution of public goods.

“The work that Canadian Blood Services has done to facilitate the convalescent plasma trials is remarkable. That we’ve accomplished this in the midst of crisis, and done it with integrity, really makes me proud of our organization.”

Kelly Holloway

Tell me about the funding you and your collaborators received?

Canadian Blood Services and the University of Toronto were awarded in partnership a Social Sciences and Humanities Research Council Partnership Engage Grant as part of a Special Initiative to address COVID-19. We were also awarded two MITACS Accelerate Fellowships and are thrilled to have two graduate student Fellows join our team.

What questions do you hope to answer with this work?

We wish to understand:

§  Does being involved with a clinical trial motivate individuals recovered from COVID-19 to donate their plasma? What do donors know about clinical trials? What do they want to see as an outcome of clinical trials?

§  How have blood collection agencies been involved in convalescent plasma trials for COVID-19 worldwide? 

§  What has the involvement of blood collection agencies meant for the legal, ethical, and practical aspects of conducting a clinical trial? And what does this mean for Canadian Blood Services?

Can you tell me more about what you will do as part of the planned research?

I will co-lead all aspects of this work with Dr. Quinn Grundy (University of Toronto).

Firstly, we will do a survey of donors regarding plasma donation and trial participation. From this, we hope to better understand the perspectives, motivations and values of enrolled and prospective clinical trial participants and plasma donors registered with Canadian Blood Services.

We’ve also started collecting data on ten prominent and public facing clinical trials of convalescent plasma from several countries worldwide. We will do an in-depth critical case study of these to understand the ways that they ensured the viability and trustworthiness of their research processes. Through this work, we will document and assess the prevalence, nature, and characteristics of the involvement of publicly funded blood collection agencies in these clinical trials.

It sounds like this project has scope beyond Canada and Canadian Blood Services. Can you tell me more?

Yes, the scope of our project will assess how the trial in Canada compares to convalescent plasma trials in other jurisdictions – not only in the results but in the nature of the partnership with entities outside of the blood services, involvement of donors, dissemination of results, etc. The project has implications for blood services internationally, as donors could increasingly become contributors to clinical trials, and blood service organizations could become intricately engaged in this form of evidence production.

What types of roles do you imagine blood operators might play in future clinical trials?

I expect that there will be future research efforts that will require donors. Blood operators can play a role in coordinating recruitment of donors at multiple sites, and have highly regulated, safe and efficient procedures in place. This represents very valuable infrastructure to support clinical trials. There are also values that guide most blood operators, such as trust, safety, quality, care and compassion, that could have a positive influence on the clinical trials landscape. When we say we’re a biological lifeline it means we attend to the whole picture - the donor, the recipient, the researcher, the staff - we take responsibility for connecting these components. There’s something unique about that approach and it suggests that blood operators may have something to offer in terms of the governance and organization of clinical trials.

What do you hope will come from this research?

We hope to identify policy opportunities to improve governance related to transparency, research integrity, conflicts of interest, open science, and equitable access to a limited supply of a novel treatment.

Ultimately, I hope that this will give us insight into the next time we need to do a clinical trial, especially in a crisis situation. The more we know, the easier it will be to move quickly, be aware of the challenges that might come up and to do things in a way that reflects our integrity as an organization.

In February 2021, the Canadian convalescent plasma clinical trials discontinued patient enrollment because they have the data needed to complete their research. Convalescent plasma collection by Canadian Blood Services has been suspended; however, Dr. Holloway and her collaborators’ study will continue and will reflect what the organization has learned through their involvement.

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The opinions reflected in this post are those of the author and do not necessarily reflect the opinions of Canadian Blood Services nor do they reflect the views of Health Canada or any other funding agency.