The journey to implement clinical research into practice can be incredibly daunting, as the role of investigator comes with significant responsibility. Nevertheless, helping to bring potentially life-altering therapies to market and therefore to patients may be one of the most rewarding aspects of a physician’s career. One option for physicians who are interested in becoming investigators is to partner with a clinical development firm or contract research organization (CRO). CROs can provide the support required for a physician to not only commence a clinical research journey but also maintain success through conducting multiple clinical trials.
PARTNERING WITH A CRO: THE DETAILS
Some practitioners who are interested in adding clinical research projects to their practice may be deterred by the substantial number of steps required before starting a study. Acquiring the proper certifications and preparing a practice to manage and oversee trials are just a few of these fundamental steps. A CRO can help support practitioners through this journey and provide guidance through the extensive list of required actions, answering any questions along the way.
The benefits of partnering with the right CRO include gaining access to site management organization (SMO) staff who will visit a practice and help set it up for success prior to initiating the first study. This may include offering staff training, study equipment, and education on protocols. An effective CRO partner should have a wide array of clinical studies in the pipeline so that their partnering physicians have consistent access to trials in their desired therapeutic area. Before conducting clinical trials, a CRO partner can provide physicians and their staff with extensive training on clinical research fundamentals, including standard operating procedures (SOPs) to ensure consistency and accuracy and to mitigate protocol deviations when conducting research.
A CRO can provide marketing support approved by an institutional review board for ongoing or pending clinical trials (eg, posters, brochures, radio ads, newspaper ads, and digital ads) to help raise awareness. Additionally, a CRO can consistently provide a practice with on-site resources, including clinical trial coordinators, clinical research associates, and imaging technicians. For example, Ora Inc., an ophthalmic research organization I frequently partner with, provides an SMO model where needed. One of the major forms of support that I use in my practice is a block enrollment method for recruiting potential clinical research participants. Block enrollment involves limiting clinical trial visits to a condensed window of time, allowing study sites to prioritize research and time with patients. This methodology has the potential to enroll participants more than 50% faster than non-SMO supported sites.
PATIENT BENEFITS
Aside from the multitude of benefits that clinical research can bring to a practice, it may provide benefits to patients, too. In several ophthalmic disease states, available therapies may not relieve all the symptoms that patients experience daily. Additionally, many patients may not be able to afford the therapies they require to experience relief. Clinical research can be used as an alternative care option for these individuals. Working with a CRO can permit access to potentially life- and vision-changing therapies in the pipeline. By serving as an investigator, physicians are offered the opportunity to bring these therapies to existing patients and potentially reach new patients as well.
The decision to engage in clinical research can be incredibly rewarding, but there are financial benefits worth considering. The leading CROs will ensure that physician-investigators are compensated for their work conducting crucial clinical trials in the ophthalmic space, essentially providing an additional revenue stream for the practice. At the same time, through working with an experienced ophthalmic CRO, physicians may gain the opportunity to build a professional network with other practitioners in their geographic area through patient recruitment programs. CROs that provide extensive patient recruitment services have agreements in place to ensure a consistent funnel of potential research participants for study screenings.
CONCLUSION
The implementation of clinical research to a practice can be made significantly smoother with the guidance and support of an experienced and well-educated CRO partner. A CRO cohort should engage in a symbiotic relationship with their principal investigators, valuing their input and expertise and prioritizing them as a part of their research community. Setting up a practice for success and maintaining that success should be a top priority for a CRO partner, with the ultimate goals to advance ophthalmic clinical research and better serve patients.
