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.
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.
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.
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.