Stroke Program Research in the Non-Academic Setting

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It might seem like a huge leap for programs operating in non-academic environments to meet the requirement for patient-centered research when seeking a Comprehensive Stroke Center designation. But we’ve seen many programs successfully navigate this challenge.  If you find yourself wondering how you’ll maintain clinical research in the non-academic setting, here are some insights that might be helpful:

How to Get Started

Finding opportunities to collaborate:

  • Participating in new device trials can allow your program to offer novel treatment options. These generally offer funding and require minimal program resources.
  • Joining multicenter trials is a good entry point for programs aiming to conduct clinical research. They often provide funding for additional resources or a fee for each patient enrolled.
  • Membership in a research consortium such as NIH StrokeNET (https://www.nihstrokenet.org/) can serve as a pipeline for small and large stroke clinical trials. 
  • Working internally on a smaller scale by asking researchable questions to promote evidence-based practice can be less resource intensive than managing large clinical trials. These are typically dubbed “investigator-initiated” trials and investigators must seek funding.
What You Will Need

Certain infrastructure and expertise will be needed to successfully engage in clinical research. Some of these include:

  • Clinical leaders and clinical research coordinators with a working knowledge of patient enrollment requirements, informed consent, protocol compliance and reporting requirements.
  • A program leader with experience with clinical research contract provisions and implementation logistics. In the absence of this, a strong relationship with a healthcare administrator is helpful to navigate contracts, budgeting, and billing.
  • A program leader with an understanding of organizational will and/or guidelines associated with conducting clinical research including regulatory compliance and institutional review board (IRB) requirements.
Who Can Help

Needed infrastructure to conduct clinical research is often perceived as a barrier to entry in the non-academic setting. However, there are often opportunities to leverage existing organizational resources. 

  • Seek out a good mentor internally (or externally) – someone with clinical research experience, preferably in the non-academic setting, who can provide insights, advice and connections.
  • Clinical research is foundational to cancer programs. If your organization is conducting cancer research, seek to collaborate and leverage their existing resources (clinical research coordinators, contractual expertise, budgeting, and financial reporting expertise, etc.)
  • Seek out departments that might be conducting patient-centered research internally, i.e., nursing, rehab services, pharmacy, etc. and tap into their experience organizing, resourcing and funding their projects.
  • If your organization has a research department, consult with them to understand their requirements or guidelines for conducting clinical research. Be sure to cover expectations for compliance with applicable regulations, ethical standards, institutional policies, and protection of research participants.
Securing Funding

I was clearly a novice when I designed my first research project. I was excited to find a program that wanted to collaborate. But I couldn’t come up with answers to their questions on how to compensate them for the effort required of their stroke coordinators. Fast-forward years later and I found numerous ways to obtain funding for efforts supported by existing staff. 

  • New device, software or medication trials generally come with funding from the “industry sponsor.” Here, the “devil is in the details!” Be sure to dig deep, understand and negotiate with the trial sponsor to make sure all aspects of the “effort” are covered.
  • Multi-center trials and consortium projects also generally come with funding for participating sites. This funding may be a set fee “per patient enrolled” in the trial. If so, it is important to determine if the program costs are covered and there is sometimes room for negotiation. 
  •  Sources of funding for “investigator-initiated” trials vary. Consult your organization’s Development Office for funding opportunities. They may also know of local philanthropic organizations that fund small projects. Small grants are often available from industry (pharma, software, technology and device companies). Ask your local rep how to access these. Also, check with advocacy organizations or regional networks for available funding.

There are significant benefits to offering clinical trial opportunities to patients. Eligible patients receive access to the latest technology, medications, diagnostic techniques at no additional cost. Their access to new treatment occurs in a controlled and monitored environment. And they often receive extra care and follow-up as part of the clinical trial protocol.

Your program benefits from clinical research as well. Clinical trials help boost your team’s knowledge. It keeps your team current in emerging technology, pharmaceuticals, diagnostics and clinical practice. It positions your program as an advocate for patients and can highlight your program nationally through publications and conference posters and presentations.

 

 

Stroke Program Research – From PSC to CSC – Strategies for Success

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As stroke program leadership ponder taking a Primary Stroke Center (PSC) to Comprehensive Stroke Center (CSC) status, one of the more common challenges is how to scale a stroke research program to meet the research standard. This is particularly challenging at non-academic centers, although academic centers often still struggle with research program sustainability.  Today, we offer suggestions for scaling and sustaining a stroke research program and successfully navigate CSC certification. 

The first tip for success is to consider the necessary administrative management of research that is required to sustain a research program.  Many clinical leaders assume that having a few passionate clinicians who are skilled in research is enough to sustain research protocols.  However, administrative support in the form of research coordinators and administrative assistance is critical for navigating Institutional Review Board (IRB) approval and protocol management.  Additionally, a strong relationship with a healthcare administrator is helpful to navigate budgeting, contracts, and billing.  Research budgets are often structured differently than departmental budgets. Most funded research protocols require a thorough budget analysis and some negotiation to ensure the project is budget neutral or even beneficial for the program. 

A second tip for success is to carefully monitor and manage enrollment in approved stroke research.  Most funded trials will close an enrollment site if screening and enrollment is lower than expected. This is understandable as it is costly for the study to maintain a site that is under-performing. Often, identification of patients and successful enrollment in a study is team effort.  Screening may be dependent on the awareness and investment of multiple caregivers and teams of individuals (e.g., emergency department, stroke team, interventional neurology for example).  All should be aware of the research protocol, the importance of research to the stroke program, and who to contact if they identify a patient who might be eligible for enrollment.  This is particularly important if the research protocol impacts patients during the first minutes and hours of a stroke, where care and treatment is time dependent.  Communication of the research protocol and site performance is an ongoing process that must be incorporated into the ongoing work of the stroke program.  

In conclusion, moving a program from PSC to CSC status will require close attention to building a sustainable and scalable research program.  We encourage program leadership to think broadly to support their clinicians who are passionate about conducting stroke research.  When executed well, both the program and patients benefit.  

Finally, a successful and sustainable stroke research program understands the critical importance of research compliance.  In our experience, most stroke programs lack expertise in research compliance and must partner with individuals or departments of research to ensure all documentation and research regulatory standards are strictly followed.  While some programs will have departments of research with whom they can consult, others may have to seek this expertise outside of their organization. This is particularly true for non-academic organizations.  Failure to meet regulatory requirements can result in the study at your site being stopped early. This can affect your program credibility for future research opportunities that may offer benefit to your patients.