Figure. Key critical stakeholders in the successful clinical research enterprise in the tertiary community private practice setting. CEO indicates chief executive officer; CRC, clinical research coordinator; FDA, Food and Drug Administration; IT, information technology; PI, principal investigator.

Introduction

Every independent private practice clinical research enterprise (CRE) is unique, being a reflection of

• Size, operations, and service scope of the overall clinical practice.
• Geography and choreography of patients across offices and location of research enterprise.
• Local medical-political-reimbursement environment.
• Personalities and politics.

As such, the path for implementation of a CRE can either be an onerous and frustrating one, or a challenging and exciting one. We propose an approach to best expedite the latter. Note that there are many exhaustive lists and overviews of tangible and intangible requirements and functions of a CRE which will not be covered here but are provided in references.^1,2 So how best to proceed and navigate this challenging path?

1. 1. Know yourself: Strengths and weaknesses, interests, and especially your disinterests. Have a realistic assessment of your managerial skills and your risk tolerance for business. It is imperative to enter this process with eyes wide open, as it is essential to be intimately familiar with all aspects of the art, science, and business of establishing a CRE.^1-3
   2. Invest in yourself: What knowledge and skill set do you need to develop? Where are the gaps in your knowledge and experience? Aggressively seek out multiple other successful principal investigators (PIs) in other private practice settings to visit and understand how their CRE programs evolved. Yours will be different with core research functions uniquely addressed for your practice environment. However, there are courses and accreditations that should be immediately sought out to add to your foundational research knowledge.^1,2 One must commit to being a lifelong learner in all aspects of research.

1. Establish a critical partnership with the practice CEO/administrator: This relationship is often underappreciated, wasting the opportunity to minimize practice-wide conflict, resulting in unnecessary misunderstandings, and in huge delays in program development. This journey of development should be taken arm in arm with the CEO over a series of meetings to discuss the following:
   1. Outline and align areas for mutual education and personal support. The process of amalgamating business and medicinal knowledge creates mutual respect. Collaboratively establish the mission and vision of the CRE. Delineate the tangible and intangible benefits of CRE to the patient, the practice, and the PI (Table 1). Appreciate the needs and concern of the key stakeholders involved in the CRE (see Figure). The PI/CEO alignment on understanding these metrics is essential in collaboratively and realistically setting expectations for success and the commitment of resources.
   2. Effect Strategic Business Planning—underscores why collaborative development is essential as few physicians are schooled in this area.
      1. Assess Opportunistic Fit—With current/proposed clinical products and services. Carefully define and propose measures of quality, volume, and bottom-line impact of the CRE.
      2. Establish Goals and Objectives—Types, number, and nature of research, typically a rolling 3-year timeframe to measure success and provide basis for flexing resources!
      3. Resource Requirements and Projections—Note an exhaustive understanding of functions needs to be developed before framing out infrastructure. Staff (research, administrative, technical, and especially financial), space, equipment, organizational relationships (pathology, imaging, clinic, etc; Table 2).¹
      4. Pro Forma Development—A concise summation of all of the above. What information do your equity partners need to see to commit and support the CRE (activity, fixed and variable, direct and indirect revenues/expenses, overhead, etc)? This involves quality and volumes, and not just bottom-line projections. Your CEO partner is invaluable in this process.
2. Evangelically garner partner support: Typically only 30% will be enfranchised into supporting your CRE (unpublished data, internal report from The CUSP Clinical Research Consortium/The CUSP Group LLC, November 7, 2020). Identify key critical physician partners not only for referrals, but also as potential subinvestigators. A vigorous evangelical approach must be embraced to continuously educate and to allay fears about patient control and financial loss, and mitigate disinterest if not outright resistance!
3. Plan to implement: If you have been successful up to this point, educating yourself, establishing CEO partnership, and curating clinical partner support, you are ready to begin blueprinting for implementation. This needs to be an exhaustive process involving a broad range of staff and needs to be well communicated to all practice stakeholders. Monitoring feedback and control are essential.^1-3

Conclusions and Recommendations

• Seek extra-practice camaraderie and intellectual collaboration. This will nurture your soul, as well as build your reputation, and open trial opportunities. Research is all about relationships.
• This is a long road. Understanding the need for persistence and tenacity is critical to your satisfaction and happiness.
• Choose collaborators and staff carefully. It is easy to become encumbered and difficult to disengage.
• Expect everything to change with success, with challenges, with you/your program maturation. If you welcome and embrace thoughtful change, you will be happier and more successful.
• Know what you don’t know! Either learn it or find someone that can manage it in your stead. Note, however, that the CRE is a feudal venture, so you are always ultimately responsible. Choose wisely.
• You need a strategic business plan that meets the needs of your stakeholder audiences. There is no one template for a viable and successful research program. Every practice will have unique geography consideration, patient choreography, personalities, and of course politics.
• The CEO/administrator is your first and key critical stakeholder. In many ways they hold the keys to your kingdom in opening time, resources, service support, and facilities. You want to have them as a partner and ally from day 1.
• Your partners, in turn, fuel the CRE practice and you must enfranchise and then garner strategic support and collaboration. But you must be realistic about expectations about collaboration and support.
• Function then infrastructure, otherwise you will find yourself limited or painted into a corner.
• Note lessons that can be learned the hard way (Table 3).