Resources

SCITRIALS.ORG is a new matching tool for clinical trials, which was created for the spinal cord injury community by the spinal cord injury community to connect the scientific community and people living with SCI. 

It was created to address some of the challenges users were experiencing on existing clinical trial sites, by providing information on trials specific to SCI, and are filtered to contain studies from legitimate universities, research centers, and hospitals.  Additionally, the site allows users to save a search unique to their preferences and then receive email updates when relevant trials in their area come online.  

To access the continually updated information in the site, simply sign up to use the free platform at SCITRIALS.ORG - we hope to see the majority of our community adopt the site, and encourage users to spread the news about this new tool throughout their networks also.

SCITRIALS.ORG is a joint initiative of the North American Spinal Cord Injury Consortium (NASCIC) and endParalysis.org – with development provided by fuelService.org 

To be an effective participant in a clinical trial or even to be an informed consumer of medical treatments or therapies, it is important to understand the research process. It is also important to understand the role of scientific peer review and regulatory oversight of medical treatments. Below is a listing of video and training resource links that provide explanations about the research process, translation, and regulatory oversight.

Gauntlet – The Body of Evidence
This is a general video that explains why a scientific review is important and the process of research from discovery to a clinical trial.
https://youtu.be/6ug9ZTewcrE

Research 101
This link directs you to training modules titled Research 101: Everyone Can Do It. This was developed at the University of Kentucky, College of Health Sciences. These modules will help to demystify the research process and they are also directed toward the spinal cord injury and disability communities.
https://www.uky.edu/chs/karrn/research-101

Navigating the Ecosystem of Translational Science (NETS)
Translational Science is defined by the National Institutes of Health as “the process of turning observations in the laboratory, clinic, and community into interventions that improve the health of individuals and populations – from diagnostics and therapeutics to medical procedures and behavioral interventions.” This training video and toolkit explains the translational research process specifically for drug development. And it is all in lay terms.
http://www.geneticalliance.org/programs/biotrust/nets

Patients Matter Video Series FDA
The U.S. Food and Drug Administration (FDA) is the regulatory agency in the United States that oversees drugs, therapies, treatments and devices that make medical claims. Gaining input from people living with medical conditions is critical for their decision-making and helps the FDA to understand the end-user needs. It is also important for the those living with SCI to understand the FDA process for approval. This link explain both the process and patient input.
https://www.fda.gov/patients/learn-about-fda-patient-engagement/patients-matter-video-series

Underlying concept

The inclusion of all stakeholders in the research process will yield stronger, more relevant, and more useful results leading to greater uptake.  People living with a disease bring an expertise that is traditionally missing from the research team. Including people living with a disease as research partners should be based on the underlying principles of reciprocal relationships, co-learning, partnerships, transparency, honesty, and trust.

Points of engagement in the research process

  1. Research question – collaborate to develop and refine a question that matters
  2. Funding application – involve in the grant development and review process
  3. Develop methods – partner to design a study people want to participate in
  4. Conduct research – integrate as equitable members of the research team
  5. Analyze data and publish – seek input on interpretation of results
  6. Disseminate – collaborate with networks to ensure results reach end users and have impact

Examples of engagement

  • Develop a consumer advisory board for the research study
  • Seek a community partner 
  • Develop a relationship with a consumer organization

Compensation for engagement

The nature, amount, and details of financial compensation should be relative to the circumstances, expertise, and degree of input of the engaged partner and at rates consistent with other members of the research team.  Compensation is an allowable budget item in grant budgets. Remember – research partners are not research participants. Compensation could be on an hourly basis, by stipend, by full day or half day, by salary, and should be flexible to financial restrictions the person with the disease may be under.  Alternative forms of compensation may include gift cards, postal money orders, donation to an organization of their choice in lieu of direct payment, gifts, in-kind exchanges. Covering expenses, such as travel, event fees, etc. is separate from compensation.

https://www.pcori.org/sites/default/files/PCORI-Compensation-Framework-for-Engaged-Research-Partners.pdf 

http://cihr-irsc.gc.ca/e/51466.html

 

Currently Available Resources

NASCIC 

  • Project Engagement Database
  • SciTrials.org
  • Partner Projects

Engagement Rubric – Patient Centered Outcomes Research Institute (PCORI) https://www.pcori.org/sites/default/files/Engagement-Rubric.pdf

The Value of Engagement – PCORI 

https://www.pcori.org/about-us/our-programs/engagement/public-and-patient-engagement/value-engagement 

Guide to Researcher and Knowledge User Collaboration – Canadian Institutes of Health Research

http://www.cihr-irsc.gc.ca/e/44954.html 

Toolkit for Patient-Focused Therapy Development – National Center for Advancing Translational Sciences https://rarediseases.info.nih.gov/toolkit

Archived webinars 

Tips on engaging people with SCI in Research

https://www.msfhr.org/sites/default/files/pictures/ISCOS_2018_%20Postcard.pdf 

The Science of Patient Input – Milken Institute Faster Cures

https://www.fastercures.org/programs/patients-count/science-of-patient-input-resources/ 

FDA CDRH Patient Engagement

https://www.fda.gov/about-fda/center-devices-and-radiological-health/cdrh-patient-engagement