About Us

The SCI Perspectives Initiative (SCI PI) is a coalition led by people living with spinal cord injuries, bringing together key SCI organizations and stakeholders to ensure new treatments better align with the priorities of people living with SCI.

Our primary goal is uniting the SCI community in funding, planning, and executing an externally-led Patient-Focused Drug Development meeting focused on SCI.

The FDA’s PFDD initiative has a strong track record of driving innovation for conditions that have historically seen limited progress

Historically, the perspectives of patients and their care partners are underrepresented in the development and evaluation of medical treatments. Before launching its PFDD initiative, the FDA recognized the need to include patient and care partner input in its regulatory decision-making, but lacked a process for systematically collecting input and ensuring it was broadly representative of the affected community.

Today, PFDD is an established, FDA-recognized process for systematically incorporating patient and care partner perspectives into medical product development and review. Meetings are designed to capture patient experience data, covering daily impacts, treatment experiences, and meaningful tradeoffs, using a standardized, discussion-based format. Meeting takeaways are often published on the FDA’s condition-specific webpage in a "Voice of the Patient" report. This report can help inform assessments of treatment risks and benefits, clinical trial design guidance, labeling decisions, and more.

Below are just three of many success stories that highlight the tangible impact of PFDD on medical innovation and regulatory decision-making:

Why the SCI Community Should Unite Around PFDD

Spinal cord injury (SCI) is a catastrophic, lifelong condition that disrupts nearly every aspect of daily life. Each year, approximately 18,000 people in the United States sustain a new traumatic SCI, with over 309,000 people currently living with these injuries. SCI often results in permanent loss of motor and sensory function below the level of injury, affecting mobility, bladder and bowel control, sexual function, and autonomic functions such as blood pressure and temperature regulation, as well as causing chronic pain and spasticity. These medical challenges are compounded by high rates of depression, anxiety, social isolation, and substantial economic burden, with lifetime costs ranging from $1.5 million to over $6 million per person, depending on age at injury and injury severity.

Despite this profound impact, there are currently no FDA-approved therapies to repair SCI. Existing treatments focus on early stabilization, rehabilitation training, and managing symptoms through medications such as corticosteroids, muscle relaxants, antidepressants, and pain relievers. These approaches do not reverse the injury and often carry significant side effects or burdens.

A significant challenge in SCI research and treatment development is that clinical trials often fail to evaluate outcomes that matter most to people living with SCI. This issue is not simply a matter of study design choices but also reflects regulatory guidance that shapes expectations for the outcomes trials must measure to demonstrate effectiveness. Many commonly used assessments are too narrow, insufficiently sensitive, or misaligned with what people living with SCI hope to achieve in their daily lives. Experts and advocates have noted that trials frequently overlook or inadequately assess the outcomes people with SCI consistently prioritize, such as regaining bladder and bowel control, improving arm and hand function, and reducing chronic pain. As a result, treatments may appear "successful" on paper without delivering meaningful improvements in quality of life for those living with SCI, while other outcomes that people consider truly valuable may fail to be recognized as successes under existing evaluation frameworks.

Surveys of people living with SCI highlight this disconnect. A 2020 survey of over 1,800 individuals with SCI and their care partners found that 90 percent want to help set research priorities, but 83 percent report they are excluded from the research process until clinical trial recruitment.

How PFDD Can Help Advance Outcomes for the SCI Community

For people living with spinal cord injury SCI, a well-executed PFDD meeting offers a rare opportunity to help overcome decades of slow progress by aligning research priorities, regulatory decisions, and therapeutic development with the community’s real needs and goals.

An Externally-Led PFDD meeting provides a framework for addressing long-standing gaps in SCI research and development. It creates a formal process for researchers, industry, and regulators to hear directly from people living with SCI about:

  • The outcomes that would most improve daily life,

  • The tradeoffs they are willing to make in treatment, and

  • The priorities that should guide innovation and investment.

Learn more about PFDD and its potential to help people with SCI:

  • SCI PFDD White Paper

    Read our white paper on organizing an effective SCI PFDD meeting, featuring expert insights and planning guidance.

    Read our white paper

  • SCI PFDD One-Pager

    Get a quick, one-page summary of why an SCI PFDD meeting is needed and how it can drive meaningful change.

    Read our One-Pager

  • SCI PI Overview

    Learn more about how the SCI PI coalition is working to develop an Externally-Led FDA PFDD meeting.

    View Our Overview Deck