JUNE - 2023 9where clinical productivity is paramount ­ the added work and time commitment to participate in clinical trials is a substantial disincentive to participation.Efficient workflows are critical to clinical practice. Without research support personnel to help the physician with candidate identification, administrative tasks, and coordination, the clinic productivity grinds to a halt and enthusiasm plummets.If you and your organization believe that access to clinical research as a standard of care option, what do you do to get out of this tough situation?A Potential SolutionThe efficient and effective conduct of clinical trials is a business imperative for pharma. Savvy research entities have realized the need to conduct clinical research like business, as opposed to a traditional academic model of research as a scientific pursuit.CROs were created in the 1970s when pharma realized the effectiveness of outsourcing research operations. Although recent regulatory changes have made this less attractive, CROs still manage significant research portfolios for sponsors. A logical extension of outsourcing is an Integrated Research Organization (IRO) which serves researchers like the CRO serves pharma. The IRO can provide services in a variety of settings ranging from individual practices to health systems.1.Infrastructure and Investment. Partnership with an IRO can bring established back-office operations, experienced personnel, and proven processes, so that your organization is not starting at ground zero. The IRO focuses on key drivers of success: efficiency, tight regulatory processes, and integrated clinical operations. IROs will have a track record of interaction with CROs and sponsors; they know the space and have insight into favorable contractual terms. In the optimal partnership, the research entity and IRO operate under a shared revenue model supported by pharma. In this model, pharma essentially ends up paying the infrastructure and operational costs with the goal of profitability for the research entity (and obviously IRO). Then, research is not a cost center and potentially contributes to the bottom line­ mitigating two major barriers to leadership support. 2.Contacts. Mature IROs have established relationships with sponsors, CROs, and other entities that can broker access to clinical trials. Leveraging the established track record of the IRO, new research entrants can gain favorable attention and earlier access to clinical trials. In addition, IROs can bring digital tools including EHR-based trial matching and clinical trial management systems that facilitate identification and trial operations ­ which significantly increase the potential for accrual.3.Physicians. Among its offerings, an IRO can embed personnel, like clinical research coordinators (CRCs) and data managers, on-site to assist with administration and coordination, minimizing physician work, preserving workflows, and sustaining clinic efficiency. Concerns about PI and Co-PI risk are minimized by robust compliance and regulatory functions. Physician compensation for the additional effort required by clinical trials becomes important in diminishing the financial disincentive. Finally, the IRO can offer research training and education to interested but "rusty" potential researchers.IROs in the marketplace exists with capabilities to meet your organization's needs. Be sure to undertake a thorough vetting and formal RFP process. Understand that your relationship with the IRO needs to be a true partnership with mutually beneficial goals and objectives, agreed on from the beginning and actively managed.My lunch with Ron ended with cautious optimism: the crucial role of clinical research in delivering the promise of new cancer therapies is too important not to find a cleft between "the rock and the hard place."Dr. Daneker currently serves as the System Lead for the Oncology Clinical Program at SSM Health. A fellowship-trained surgical oncologist, he has a long history of participating in basic, translational, and clinical research at institutions including Harvard Medical School, UTMD Anderson Cancer Center, Emory University, and the Georgia Institute of Technology. Contact him at https://www.linkedin.com/in/george-w-daneker-jr-md/. A logical extension of outsourcing is an Integrated Research Organization (IRO) which serves researchers like the CRO serves pharma
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