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Perverse Effects: How Insufficient Guidance to IPFs Can Undermine Both Research and Health Outcomes of Clinical Trials

Autoimmune Related Diseases Association 2018; American Cancer Society 2018). If we additionally take into account the indirect costs (e.g., loss of employment, loss of workplace productivity, disability costs, caretaker costs, etc.) and perhaps more intangible costs (e.g., chronic or frequent pain, depression or other corresponding mental health costs, etc.), the magnitude of burden associated with autoimmune diseases—and by implication the magnitude of benefit incurred by any corresponding cure—is arguably sufficient that it would not be unreasonable for someone to rank it “high” alongside the authors’ high magnitude of medical benefit diseases (ALL, neuroblastoma), both individually for potential study participants and at a societal level as well. Although this does not in itself disprove Jecker and colleagues’ ranking criteria, it does call into question whether their ranking is the best or only one to use when considering immunotherapy production facility (IPF) trial selection. In the end, I share Jecker and colleagues’ position that we should be proactive, rather than reactive, when it comes to CAR T-cell therapy/patient-specific active immunotherapy and applaud their efforts at developing ethics-based and transparent criteria for managing trial enrollment in light of presumed resource scarcity for this breakthrough therapeutic intervention. However, given the preceding argument I strongly suspect that there is more work to be done on this—or any other—proposal for IPF trial enrollment before it is ready for real-world implementation.