Best Practices from the American Society of Pain and Neuroscience (ASPN) for Clinical Research During a Pandemic or Emergency

Abstract

The COVID-19 pandemic caught many areas of medicine in a state of unpreparedness for conducting research and completing ongoing projects during a global crisis, including the field of pain medicine. Waves of infection led to a disjointed ability to provide care and conduct clinical research. The American Society of Pain and Neuroscience (ASPN) Research Group has created guidance for pragmatic and ethical considerations for research during future emergency or disaster situations. This analysis uses governmental guidance, scientific best practices, and expert opinion to address procedure-based or device-based clinical trials during such times. Current literature offers limited recommendations on this important issue, and the findings of this group fill a void for protocols to improve patient safety and efficacy, especially as we anticipate the impact of future disasters and spreading global infectious diseases. We recommend local adaptations to best practices and innovations to enable continued research while respecting the stressors to the research subjects, investigator teams, health-care systems, and to local infrastructure.

Keywords:

• research
• pain
• emergency
• pandemic
• protocols

Acknowledgments

Third-party editing assistance was provided by Allison Foster, PhD, of Foster Medical Communications. Erika A Petersen and Timothy R Deer are co-first authors for this study.

Disclosure

Dr Erika A Petersen reports personal fees from Abbott Neuromodulation, Biotronik, Medtronic Neuromodulation, Presidio Medical, Saluda, and Vertos; stock options from and Board of Directors for SynerFuse; stock options from Neuro.42; supported research for Nalu, Nevro, Mainstay, SPR Therapeutics, Neuros Medical, and ReNeuron, outside the submitted work. Dr Timothy R Deer reports personal fees from Abbott, Vertos, Saluda, Nalu, Cornerloc, Ethos, SPR Therapuetic, Medtronic, Boston Scientific, PainTeq, TissueTech, Spinal Simplicity, and SpineThera; research for Mainstay and Avanos, outside the submitted work. In addition, Dr Timothy R Deer has a patent pending to Abbott. Prof. Dr. Frank Huygen reports personal fees from ABBOTT, grants from Saluda, outside the submitted work. Dr Michael E Schatman is a research consultant for Modoscript, outside the submitted work. The authors report no other conflicts of interest in this work.