Novel challenges of multi-society investigator-initiated studies: A paradigm shift for technique and technology evaluation

The introduction of innovative techniques and novel technologies into clinical practice is a challenge that confronts all aspects of healthcare delivery. Upheaval from shrinking research funding and declining healthcare reimbursements now forces patients, doctors, hospitals, payers, regulators, and even health systems into conflict as new therapies struggle to find a place in the therapeutic armamentarium. The escalating costs of healthcare force all parties to consider both the medical risks/benefits as well as the economic efficiency of proposed tools and therapies. We highlight these challenges by examining the process of initiating and conducting a "society-as- investigator" clinical trial to assess the safety of the natural orifice translumenal endoscopic surgery (NOTES) approach to cholecystectomy in the context of the issues that confront technology diffusion today.