Community Clinics as Trial Sites—Bridging the Gap Between Health Care and Clinical Research

It should come as no surprise to anyone who works in clinical research that the vast majority of eligible patients and physicians do not participate in clinical trials. Among patients with cancer, for example, estimated clinical trial participation rates are as low as 3 percent.[1] One study found that only 16 percent of patients with cancer were even aware of relevant clinical trials, and that only 43 percent of these individuals enrolled and participated in a trial.[2] Low participation rates are not limited to oncology clinical trials and point to a fundamental problem affecting all therapeutic areas: There simply aren’t enough patients to populate clinical trials; nor are there enough trial sites that are convenient to patients. Even when they are able to meet enrollment targets, many trials struggle to adhere to enrollment timelines, forcing sponsors to extend overall trial timelines and delay regulatory submissions. As a result, many approved medications are brought to market later than anticipated, depriving patients of their benefits until they are made available. Addressing the problem of low patient and physician participation requires a re-thinking of the recruitment process. Rather than follow the traditional model of recruiting from the same limited pool of patients, and then directing patients to research sites, a new model essentially brings the research sites to the patients. Specifically, the new approach mobilizes community clinics and turns them into research-enabled sites that enroll eligible patients who already populate their practices, thereby expanding the pool of participating patients and clinicians. The opportunity to be treated by one’s own trusted physician in the context of a clinical trial close to home serves as a powerful incentive for patient participation, and can preserve the bond between patient and physician. The community-clinic-as-trial-site model also serves physicians’ interests by allowing them to participate in clinical research-a motivating factor for many to become physicians in the first place-while providing potentially cutting-edge therapies to their patients. The ability to treat one’s patients as part of a clinical trial also preserves the continuity of care, as the physician investigator does not have to refer patients to another practitioner in another location in order to participate in a trial. The model generates revenue for physicians’ practices, and enables the clinicians to stay current with evolving therapies. Bringing Research to the Clinic Turning community clinics into research sites requires provision of personnel, processes, technology, and infrastructure to conduct clinical research. Our Elligo Goes Direct™ model does this by placing our study managers and clinical coordinators on site at participating clinics, relieving clinics of the tasks associated with hiring and training staff. Elligo leverages a clinic’s electronic health records (EHR) system to find patients for existing clinical trials, which are contracted by pharma sponsors and clinical research organizations. For each trial, the protocol’s inclusion and exclusion criteria are utilized to identify eligible patients from within the clinic’s practice. Following a feasibility assessment and institutional review board (IRB) approval, the study managers coordinate with physicians and clinic staff to contact the eligible patients and invite them to meet with their physician to discuss the possibility of participating in the trial. The Elligo study managers and coordinators also help the clinics comply with the myriad administrative and regulatory requirements for conducting a clinical trial, and use a clinical trial management system to collect and enter data. Again, the on-site personnel can take care of these clinical trial elements rather than the physicians or clinical staff. Another advantage for clinics is that they do not have to invest in any new technology or equipment. If, for example, a study protocol requires a -20° freezer for storage of samples, but the clinic lacks such a freezer, Elligo will provide and install it at no charge to the clinic. The model also benefits sponsors by providing them with more diverse pool of patients than is typically found via traditional recruitment methods. Rather than continuing to mine the same 3 percent of patients and physicians who already participate in clinical research, it stands to reason that on-boarding community clinics as trial sites will grant sponsors access to an expanded pool of patients. This group of trial participants is more culturally, ethnically and economically diverse, yielding a more representative sample of the population. The Goes Direct™ Approach: A Case Study The utility of the clinic-as-trial-site model is illustrated in a recent case involving a community obstetrics and gynecology clinic that Elligo secured as a site for a Phase II trial of an investigational oral pain medication for endometriosis. The trial sponsor had been struggling with patient enrollment and engaged Elligo to facilitate this process. Elligo identified the clinic as a potential trial site and initiated discussions with the practice’s physicians. The practice had long been interested in engaging in clinical research, but previous forays into the research field were unsuccessful, as the logistics were cumbersome. The physicians found it difficult to manage the added workload, and were unable to balance their regular patients and obligations with the demands of leading a study at a stand-alone research center. Additionally, when patients were informed of a trial they qualified for, they were either unable or reluctant to travel to a distant research site. After conducting a brief needs assessment, Elligo study managers joined the clinic staff full-time, handling all aspects of clinical trial management including contracts and budgets, regulatory documents, and communications with both the sponsor and IRB. Then, using the clinic’s EHR system, the team identified patients within the practice who qualified for the endometriosis trial. The practice’s physicians then contacted the eligible patients to propose the opportunity, and coordinated the enrollment responsibilities to the study managers, who guided the patients through study visits and assumed day-to-day logistical oversight. Within a month, the Elligo team had the site infrastructure in place, patients enrolled and the study underway, taking care of data collection, AE reporting, sponsor communications, and other essential tasks. Rather than working as a separate entity within the practice, the team quickly formed relationships and integrated with the clinic’s medical assistants, health specialists, officer manager, physicians, and other office staff. Additionally, the study managers became the patients’ main point of contact, available to answer questions, facilitate appointments and generally ensure a positive experience. In just eight months, the clinic became the highest screening and highest enrolling site for this study in the United States-despite having started the trial four months later than all the other participating sites. Patient reactions have been positive, with the majority expressing appreciation for the opportunity to participate in novel research while under the care of their own physician. Many patients expressed excitement about the opportunity to be involved in research that advances women’s health even though they may not directly benefit from the endometriosis study. As of this writing, the study is ongoing, with additional patients being enrolled. It stands to reason that patients are more likely to continue to participate and adhere to a trial protocol when they can do so under the care of their own physician, at a site close to home. Community clinics thus constitute an abundant, diverse source of clinical trial participants. They should be especially attractive to pharmaceutical companies that are running multiple trials in a particular therapeutic area, with a limited number of sites competing against each other to recruit patients from the same limited pool of potential participants. By activating research-naïve or research-challenged clinics as full-fledged trial sites, and by providing those sites with logistical support at no cost, the clinic-as-trial-site model bridges the gap between health care and clinical research. Moreover, by lowering or eliminating many of the barriers to patient participation, the model can streamline the research process itself, allowing drug developers to bring their products to market more quickly and improve public health. Keith Fern, Chief Commercial Officer, Elligo Health Research [1] EDICT. The EDICT Project: Policy Recommendations to Eliminate Disparities in Clinical Trials. Houston, TX: EDICT Project; 2008. [2] Fenton L, Rigney M, Herbst RS. Clinical trial awareness, attitudes, and participation among patients with cancer and oncologists. Community Oncology. 2009;6(5):207-228.