The Prtotocol-Provided Clinical Research Model as an Evolving Research Opportunity for Community-Based Hospitals and Health Care Facilities

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There is an evolving model of protocol-provided clinical research that has become more standardized as a research pathway over the last several decades. This model, with reduced research-specific infrastructure requirements and whose trial processes, management, and business operations are very similar to those of standard-of-care clinical and business operations performed by community-based patient-care facilities, now offers a pathway for traditionally non-university-affiliated “nonacademic” community-based hospitals and health care facilities to enter into the arena of clinical research.






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Severance, HW, and KM Spiegel (2016). The Prtotocol-Provided Clinical Research Model as an Evolving Research Opportunity for Community-Based Hospitals and Health Care Facilities. Technology and Innovation, 17(4). pp. 211–217. 10.3727/194982416X14520374943185 Retrieved from

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Harry Wells Severance

Adjunct Assistant Professor in the Department of Medicine

Site Principle Investigator: PROspective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) prospective, randomized, multi-center clinical trial:

Principle Investigator - Duke E.D. Site - "Speed" Study. Pilot phase of Gusto IV. Investigating Abciximab (a GP IIb-IIIa inhibitor) in combination with rapid access to cardiac cath. Funded through Duke Clinical Research Institute. Multi-center trial.

Principle Investigator - Project: proposed mechanisms for afferent pain transmission from myocardial cells to pain centers. Purpose is to identify potential biochemical markers for early anginal presentations. Funded: grants received from Merck & Co. and Roche-Boehringer-Mannheim. Pilot phase paper - in preparation.

Other Interest Areas:
Wounding and medical management of penetrating injuries derived from firearms and blast-related injuries.

Impact of Observation/short-stay strategies on clinical care and inpatient/outpatient systems.

Impact of Emerging Viral Threats on clinical management and social/economic/political systems,

Acute Cardiology - Chest Pain Presentations 
Evolving Technology and AI in improving clinical care/management

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