Overcoming the Barriers of Integrating Clinical Research into Physician Practices

Historically, research has been a difficult pursuit in the community outside of the academic setting. Many programs start and subsequently fail due to challenges outlined herein, leading to the ‘one and done’ phenomenon experienced over 50% of community-based research programs.1

Premier community practices have a long history of partnering with service providers that bring the necessary expertise and resources to insure a sustainable, scalable, and profitable ancillary service line. This has never been more important than in the arena of clinical research.

The core challenges lie in the reality that the business model for a clinical research program is vastly different than the model for conducting a successful and profitable medical practice. Pharma sponsor relationships can take years to develop. Initiating and sustaining a program can be costly and time consuming for the novice. Trial selections are often made based on interest in disease state without considering subject access or aspects of the trial protocol that create friction in the clinical workflow of patient care. Practices often take a ‘try and see’ approach, hiring a single coordinator and conducting a few trials.

Sub-scale programs, however, risk the devastating effects of a sole clinical research coordinator leaving. Without appropriate staffing and oversight, regulatory consequences may follow due to inadequate qualified staffing, data management errors or failure to comply with the standards established by the IRB and FDA for conducting clinical research. As in healthcare, quality is key to a successful program and the standards for research are rigorous. Hiring and managing qualified research staff takes focused expertise that is typically beyond the scope of the practice administrators experience. Budgeting and contracting for Pharma sponsor-initiated research is its own specialty area and expertise is essential to insure a sustainable and profitable research business.

Who is going to have the skill and band width to manage and grow the research business when practice physicians and administrators are busy with patient care and managing their core clinical practice?

At ObjectiveHealth, we provide an integrated clinical research joint venture model partnering with premier GI and primary care groups across the nation. We bring the expertise necessary to create and build sustainable, scalable, and profitable research programs with our partners that transform patient care and the patient experience. We hire, train, and manage imbedded research teams with highly qualified personnel that love patient care. Our programs enhance the brand of the practice and extend the reach of services beyond the four walls of the clinic.

We bring the sponsor relationships, expertise in budget and contracting, quality and compliance structure and oversight, and the benefit of a vast network of sites that enhances trial opportunities and service pricing. Core data science technologies allow us to identify and rank patients for trials based on specific study characteristics and monitor key performance indicators across our network. We select research with our partners that reflects the future directions in GI and primary care with a focus on population health and silent chronic disease states like fatty liver disease. Our core strength lies in the capacity to create custom workflow solutions with our partners that allows for research to be frictionless in the constructs of the busy clinical practice.

1 https://doi.org/10.1016/j.conctc.2017.02.009