Basics of the Clinical Research Industry

1. Basics of the Clinical Research Industry Clinicalresearchstudiesdonotnecessarilyallinvolvemedicaltreatmentsorexperimentaltherapies.Clinicalresearchcanincludeobservationalstudies,inwhichpeoplearefollowedoveraperiodoftimetodeterminehealthoutcomes.Clinicalresearchmayalsobeusedtodeterminetheusefulnessorsafetyofanewdiagnosticprocedureordrugtreatment.Clinical Research Coursesareplannedinadvanceandfollowadefinedprotocol.Epidemiologicstudiesexaminespecificpopulationstoclarifyhowoftenadiseaseoccursorisfoundinagivengroup(theincidenceandprevalence),theindividualfactorsthatcancauseorworsendiseaseprogression,andthetypesofhealthandlifestyledecisionsthatpeoplemake. Before we talk about the consolidation trend between clinical trial sites, it is important to distinguish between two business models in the clinical research industry: 1. Free-standing research sites, or dedicated research centers These sites only perform research and do not provide ongoing clinical care (outside of the study duration). They have a dedicated facility, hire physicians as employees or contractors to serve as principal investigators, and source their patients from advertisements, their subject database, partnerships with health care providers, and community outreach. The advantages enjoyed by these free-standing clinical trial sites are focus and greater ability to control operations, but they generally require more capital and operate at higher break-even thresholds.

2. 2. Physician affiliated clinical trial sites These sites are co-located within physician practices and manage research on behalf of those practices. They use the physician’s facility, source patients primarily from the practice database, and share revenue with the physician. This arrangement is more subject to the whims of the practice, but is easier to scale, with lower break-even thresholds. A site network is simply a combination of sites pursuing one or both of the above models. Some networks are exclusively free-standing; some are exclusively managed (SMO); and some combine both types under one operation. For instance, a local network might resemble a hub-and-spoke, with a large stand-alone site (the hub) that sends coordinators over to neighboring physician practices to manage operations (the spokes).