The Reality of SCI
Today, SCI is one of the greatest survivable catastrophes experienced by a human being and costs the Canadian government approximately $2.7 billion per year. Despite the amount of funding that supports basic research, few discoveries reach their potential and the various transitions from bench-to-bedside research are so fraught with obstacles that they are often referred to as “valleys of death”.
What is Praxis?
Praxis is RHI’s solutions-focused model that was developed to help overcome obstacles in SCI research in order to achieve improved health outcomes for people with SCI and decrease the financial impact on the healthcare system.
The Praxis Model includes three essential components:
- A Coordinated Program Strategy: A set of four distinct, but interrelated programs – Cure, Care, Consumer and Commercialization Programs ensures all projects and activities are focused on reducing the impact of paralysis.
- Knowledge Cycle: A four stage cycle - Environmental Scan, Knowledge Generation & Synthesis, Knowledge Validation and Implementation – that helps drive SCI research forward
- Infrastructure & Resources: Tools to help overcome the obstacles which prevent research from reaching the bedside. At RHI, our infrastructure and resources include: Funding, Clinical Research Operations, Clinical Research & Best Practices Implementation, Informatics, Consumer Engagement, Collaborative Networks and Strategic Partnerships.
Praxis is a unique model, not only to SCI research, but also to the broader life sciences and healthcare sectors. What makes it unique is not the individual components, but the combination of components and our role as agents of change. By working towards solutions to problems such as secondary complications after spinal cord injury and paralysis itself, we can play an instrumental role in improving the quality of life for individuals with SCI.
It is estimated that only 14% of health-related scientific discoveries enter into medical practice and that it takes an average of 17 years for them to do so.
> Read the peer-reviewed paper in the Journal of Healthcare Leadership.
> Download the Praxis Fact Sheet
> Read RHI's submission to Health Canada's Advisory Panel on Healthcare Innovation
Online Discussion and Feedback
RHI invited experts from a wide range of backgrounds to seek feedback on our model and begin a dialogue on how to bridge the valleys of death in SCI translational research.
The following is in consideration of the comments we received.
A work in progress
A key reason we invited leading scientists, clinicians, academics and consumers to comment on our model was to solicit feedback for improvement and ignite discussion. The road ahead to improved outcomes for people with SCI is not easy. And the journey is a marathon, not a sprint. However, what the Praxis Model enables us to do is make better, and more informed decisions regarding the allocation of scarce resources. The Praxis Model cannot support everything that is relevant to providing solutions to people with SCI. But it can accelerate progress in SCI research and care by instilling a disciplined strategy.
Working together to solve a devastatingly complex problem
Spinal cord injury is an extremely complex problem placed within a relatively small population which makes it difficult to study, adequately resource and conduct clinical trials. However, we have learned a lot from other conditions including the importance of connecting researchers around the world to share knowledge; creating accreditation standards so that people with SCI receive the same level of care; and involving relevant stakeholders in all phases of the knowledge cycle.
A paper published in 2011 by Francesco Marincola in the Journal of Internal Medicine highlighted the Trouble with Translational Medicine. All too often, translational research is caught in the “feedback cycle whereby complex, multi-factorial disease is confronted without sufficient understanding of human pathophysiology.” This lack of understanding is one of the main obstacles identified and incorporated into RHI’s Cure Program and we recently announced winners of a competitive bid to further research in this area. Another obstacle highlighted by Marincola, is the lack of sufficient priority placed on learning from failure, which often leads to repeating the same, costly mistakes. Our approach to this is the development of a coordinated program strategy (Cure, Care,Commercialization, Consumer) – each with a specific set of goals and objectives, but all committed to accelerating our vision of a world without paralysis after spinal cord injury.
How to overcome the "valleys of death"
Many experts commented on the lack of sufficient outcome measures – a prevalent and much discussed obstacle in overcoming the “valleys of death”. We agree these are important questions and that the model needs to evolve to address them. In a recent review of knowledge translation in SCI through our involvement on the SCIRE project, we reached a similar conclusion that there are no clear criteria when to translate clinical research into clinical practice. In both “valleys”, the development of criteria is an important piece of the solution. It is also important to note that the term “valley of death” gets used in a variety of contexts and the definition often depends on the context. We have attempted to apply the term in a way that is relevant, and to some degree, generalizable to the SCI research and care continuum. In other words, we see the translation from preclinical to clinical and clinical to implementation into the delivery of health care for people with SCI as representative of the “valleys of death” in our context. In reality, the nature and details of the “valleys of death” are much more complex and are often unique to the innovation that is being developed. For example, the challenges faced by those developing a therapeutic, such as a small molecule or biologic, are different from those faced by those developing a medical device. Furthermore, we do not intend to imply that these are the only barriers to advancing an innovation through the development process. The proverbial “devil is in the details” and how the Praxis Model is applied will ultimately depend on the specific context of the innovation or best practice that we are trying to advance.
Here are some additional ways we are working to define success when validating scientific discovery:
- Development of program advisory committees and roadmaps. Membership of these committees includes individuals from our clinical research network and leading international subject matter experts. Several advisory members sit on more than one committee to bring balance and a variety of perspectives from the SCI cure and care continuum. Three of the committees have formalized a roadmap which outlines the programs’ strategic objectives and the Consumer committee hosted its first annual meeting in late 2014. Click here to learn more about RHI's Programs.
- Providing opportunities for competitive funding to align with objectives outlined in our program roadmaps. As mentioned above, RHI has launched a competitive funding process which will enable us to work on the most promising research and meet objectives outlined in our programs. View the latest winners.
- Collaborating with researchers and consumers to identify barriers to success. We are also partnering with international organizations to share lessons learned from leading international multicentre trials as well as to discuss the benefits and barriers to international collaborations and clinical trial participation. A survey about the barriers to international research is currently underway and we encourage clinical researchers to participate.
- Refining the Commercialization Program. RHI is exploring ways in which it can better leverage the resources in its network to advance the development of innovative technologies towards commercialization and bridge the “valleys of death”.
- Hosting an international meeting to turn SCI research into outcomes. To further address the translational “valleys of death”, RHI set praxis as the theme of our 2016 international meeting. Praxis 2016 provided a unique opportunity for clinicians, scientists, people with SCI, community and advocacy organizations, policy makers, industry and investors to discuss collaborative approaches to bridging the translational “valleys of death” in SCI research and care. It is expected that Praxis 2016 will result in specific outputs that will advance the field forward towards meaningful outcomes for people with SCI. Praxis 2016 was hosted in Vancouver, BC, on April 25-27, 2016.
Another common theme we found in the responses was the importance of involving consumers. Here are some ways we are working to address this:
- Developing a consumer engagement strategy. One of RHI’s four main programs, the Consumer Program aims to provide resources and tools to people with SCI and their families to help answer his or her most critical questions in the months following injury. The program also involves developing tools and activities to promote research participation and to educate consumers about SCI research progress and its value. As mentioned above, we are currently in the process of formalizing a consumer advisory board and expect to announce board membership shortly.
- Engaging SCI consumers in RHI projects. As part of our effort to better engage consumers, we actively involve people with SCI in our grant and project review process. Inviting consumers from a diverse array of backgrounds, more than 15 projects have been reviewed through our competitive funding and grant review process.
- Nurturing the best and brightest in SCI research. Through our Best and Brightest program we are working with organizations and academic institutions across Canada to provide funding for up and coming SCI researchers. Learn more about our Best and Brightest Program and meet the two newest members of RHI’s research network and recipients of a Michael Smith Foundation for Health Research Scholar Award, jointly funded with RHI.
What’s next for the Praxis Model?
We will continue to develop activities, collaborate with leading experts and participate in projects that make sense for our organization. As our model evolves so too will our organization and we will continue to invite feedback and discussion on how we can improve so that one day, a world without paralysis will no longer be our vision, it will be our collective reality.