Finding opportunity in the industry-sponsored clinical trial arena

Take-home message: Participating in clinical trials can be rewarding. Not every eye-care practice is set-up for participation in clinical trials, but for those that invest the time and energy to become a high-quality research center, the benefits to both practice and patients can be quite significant. By Chad Ice Health-care providers all over the United States participate as investigators in clinical trials for pharmaceutical products and devices. However, engaging pharmaceutical company sponsors and clinical research organizations (CROs) to access opportunities may be challenging for clinicians hoping to penetrate the industry-sponsored clinical trial arena. Pharmaceutical company sponsors and CROs are seeking experienced investigators and sites, but how do clinicians naïve to industry-sponsored clinical trials present themselves and their practices as potential clinical investigators and a viable clinical trial sites? What features can distinguish clinicians and practices as eligible and desirable clinical investigators with high-quality and robust clinical trial sites? Next: What’s in it for clinics? There may be benefits for eye-care practitioners and patients when the practice is involved in industry-sponsored clinical research. Clinical research may allow patients access to potentially beneficial treatments not accessible or commercially available as they are still under investigation and not approved by the FDA. This provides new options for medical treatment, and generally is at no cost to the patient. Participation in clinical research may increase the visibility and prestige of an eye-care practice. Clinics grow their patient base through participation in clinical research, which often utilizes advertising and media to recruit patients for participation in trials. Likewise, sponsors are required by law to post clinical trials and participating sites to ClinicalTrials.gov. This public database may be viewed by patients seeking clinical trial opportunities and searching for sites conducting trials related to their condition or disease. Another benefit of participating in industry-sponsored trials is that sponsors often recruit investigators who have participated in their trials to advocate on their behalf via journal publications and/or speaking opportunities in which they may present trial outcomes and/or discuss potential pathways for the product development. These activities increase visibility for the clinician and their practice. Likewise, this platform can offer networking opportunities with other eye-care providers, as well as an introduction to other sponsors, resulting in future opportunities in clinical research. Next: What are sponsors/CROs looking for? Although clinical research activities may appear similar and in line with the everyday activities of seeing patients in an office, there are details that are critically different, and the work may require additional and nuanced resources to meet the unique challenges and demands. Not all eye-care practices have adequate resources specifically allocated to conduct clinical trials. A challenge for eye-care practitioners hoping to penetrate the world of clinical research is often the rigorous requirements and expectations set by sponsors and CROs when selecting potential investigators. It is critical for sites with little or no clinical trial experience to demonstrate to sponsors/CROs their knowledge of Good Clinical Practice (GCP), the intensity, and scope of clinical trial activities and a general understanding of the sponsor’s expectations. For example, it is generally expected that a clinical research center will have a dedicated research coordinator whose primary focus is on subject recruitment and formal screening and evaluation of potential clinical trial patients. The research coordinator also has the job of case/data collection report form completion, reporting to Institutional Review Boards (IRBs), completion and processing regulatory and essential documents required by the sponsor and the FDA and the research coordinator is expected to participate in and facilitate routine sponsor monitoring visits. Potential investigators also need to demonstrate that they have the time to participate in the study as well, as clinical trial visits are more involved than regular patient visits. Investigators are required to participate in the informed consent process, complete significant regulatory documentation, make sure all site staff are trained on the trial and any new information that is provided, meet with sponsor or CRO representatives who are monitoring the study, and evaluate and follow-up on safety events. Investigator assessments of study participants at trial visits are also generally more extensive than those that would typically be performed during a routine patient exam. Potential investigators also need to be knowledgeable of the requirements mandated by federal regulations on investigators and the details of their Institutional Review Board reporting requirements. For example, eye-care practices associated with academic institutions or physicians who may be performing certain trial activities at a hospital, are typically required to report to the institution’s or hospital’s IRB and/or multiple hospital committees, and not the sponsor’s central IRB. It’s very important to know your own requirements, as they can often dictate how quickly your site can begin participating in a trial. Next: How to be selected as a clinical research site There is an ongoing need for productive and dependable clinical research sites. Experience and a reputation as a high-quality and high-performing site are the most impactful factors for consideration when a sponsor and a CRO are recruiting investigators for a trial. However, if you are a site new to industry-sponsored clinical research, the first step is to make connections with sponsors and CROs that are conducting and recruiting investigators for participation in clinical trials. Investigators also commonly provide referrals to sponsors and CROs regarding other eye-care practitioners they believe would make good clinical trial sites. Networking with these eye-care practitioners can be a great way to make an introduction to a sponsor or CRO, especially if you don’t have previous research experience. First impressions are extremely important for inexperienced sites in clinical trials, as they invariably influence the decision of a sponsor or a CRO regarding future trial participation. It is vital to focus on trials in a disease area in which there is significant experience and a large patient population from which to recruit. Eligibility for trial participation, however, is not measured exclusively via potential for high enrollment of trial patients. The ability of a site to provide quality documentation (essential regulatory documents and data collection), responsiveness of the staff, and attention to detail, are factors as impactful as enrollment numbers. Sponsors and CROs request information from sites frequently throughout the trial, and the responsiveness and professionalism of the site to such requests is a strong indicator of the level of prioritization placed on clinical trials by the practice. The capabilities of a research site-as evidenced by both time dedicated and staff professionalism-comes through clearly to sponsors and CROs. Further, demonstrating a robust understanding of the specific requirements and demands of conducting a clinical trial at your practice and a foundational knowledge of Good Clinical Practices (GCP) can make an important impression on the sponsor and reflects your orientation to the industry standards and your commitment to the work required. Although enrollment is not the most important indicator of quality performance, it is important that the investigator make an accurate estimate of the number of patients at their site that they are likely to recruit and successfully enroll into the study. Sponsors understand that there are often limiting factors in enrollment, such as rigid eligibility requirements, but they rely on the investigators to accurately assess their capabilities. Failure to do so may hurt the chances of the site to be included in subsequent trials. Sponsors and CROs are generally held to tight timelines for enrolling and conducting a trial, and therefore it is critically important for their own performance that they meet their goals. It’s important to set realistic expectations and timelines for the site and meet them, rather than to aim too high and fall short. Next: Conclusion Participating in clinical trials can be very rewarding, but it is important to realize it can be challenging, time-consuming, and requires a high level of attention to detail. Not every eye-care practice is set-up for participation in clinical trials, but for those that invest the time and energy to become a high-quality research center, the benefits to the practice and patients can be quite significant. Chad Ice is president and founder of Lexitas Pharma Services (www.lexitaspharma.com), a full-service clinical research organization specializing in ophthalmology.