Recent rapid advancements in genitourinary oncology therapeutics and diagnostics are a direct result of well-designed and executed clinical trials, bringing new therapies and devices to the marketplace while also expanding on the indications for already approved products. The “menu” of options for urological cancer patients is growing at an unprecedented rate, and large independent groups are having to adjust accordingly. Independent research programs benefit our patients, our practices, and our physician investigators, while aligning us with our academic colleagues. In this commentary we discuss why continued development of independent clinical trials infrastructure is healthy for our patients and practices while recognizing obstacles to program success.

Practice Level

Independent, large urology groups have recognized the benefits of an efficiently run and well-managed research department for over a decade. These programs increase visibility, legitimacy, and revenue for our practices, and fit in nicely with an independent group’s ancillary service lines. Additionally, community patients are highly sought after in research settings as these patients often represent a more realistic and diversified array of disease, comorbidity, and socioeconomic status than those typically recruited at academic sites. The phrase “real-world data” has recently been popularized as it applies to this concept, and many trial sponsors recognize the importance of patient diversity.

Successful management of practice-related research endeavors can be done efficiently with low overhead while meeting the needs of both sponsors and patients. Initiating an independent clinical trials program requires an understanding of practice-specific infrastructure limitations and insight into the contracting process, which may dictate what type of trials a site can conduct. Smaller sites and those without procedural or advanced therapeutics capabilities may focus initially on registrational trials, retrospective analyses, or biomarker trials with easy to obtain blood, urine, or tissue. The evolution to phase 3 and interventional (drug or surgical) trials occurs over time as the program becomes more successful and sophisticated with trials oversight, administration, and contract negotiation.

Obtaining experience in trial interventions enables a large practice to gain valuable experience with a therapeutic that may become standard of care, giving them a potential head start at expanding therapeutic resources. In a competitive health care climate, developing and honing a successful clinical trials program has substantial benefit to the practice. Practices incorporating trials have greater impact in their communities and often have better access to multidisciplinary cancer care. Many new physician recruits are aware of and have performed research at their recent academic institutions, and many fellowship-trained graduates are interested in continuing this expertise in an independent setting.

Negotiating effective contracts with sponsors will be essential to the continued growth of clinical trials research at the practice level. Sponsors have special interest and motivation toward high-performing independent sites given low barriers to entry, fewer regulatory obstacles, and ease in site activations and patient recruitment. When contracts are negotiated properly, revenues from clinical research can support other clinical endeavors. In an environment of declining patient evaluation and management reimbursement, research programs may supplement practice income with minimal additional overhead, making them attractive options to maintain practice growth.

Physician Level

Physician-led research programs have several benefits for participating doctors. They include personal career development, establishing leadership roles within the practice, maintaining practice diversity, and an opportunity for aging surgeons to transition their role within the practice.

For physicians with a desire to remain academically productive outside of academic organizations, clinical research allows integration with outside academic investigators, colleagues, and industry sponsors. Collaborative groups championed by the Society for Urologic Oncology and the AUA, focusing on clinical trials research, have proven extremely successful in fostering the relationship between independent practice and academic urologists. Collaboratives have improved trial recruitment, allowing sponsors to reach accrual more quickly while providing them with access to potentially underrepresented patient populations.

Patient Level

The final and most important reason to pursue a clinical trials program is patient benefit. Patients are increasingly aware of growing options in cancer care and utilizing a personalized approach toward their disease. Many patients are interested in organ-preserving options, and being able to offer a noninvasive surgical alternative (eg, an intravesical trial in lieu of radical cystectomy) can be a huge win for patients. The strict protocols and frequent visits used in clinical trials are often helpful in minimizing treatment-related morbidity and optimizing surveillance for these patients.

Obstacles

Despite these benefits, there are hurdles that independent sites must address to allow for high-level clinical research. There needs to be a practice level commitment of capital and resources to ensure appropriate research support. As part of this practice commitment, infrastructure and staffing requirements need to be prospectively outlined and modified based on the level of research sophistication and trial type to support and grow the program. A clinical research manager or coordinator may incur additional cost but can be invaluable in assessing these needs and allowing for the trial portfolio to continue to grow.

Groups must also commit to certain space requirements that would allow for research activities to occur. Clinical exam space is often necessary for patient visits as well as coordinator office facilities and binder and source document storage. Physicians and investigators carry the ultimate responsibility for trial activity, including patient safety, regulatory reporting, and source document recording, which can continue for several years after trial closing. Opening a trial at a site represents a commitment to fulfill those responsibilities or arrange transfer to another responsible physician if their practice shifts focus.

In conclusion, there are several benefits of pursuing clinical research in community urology. While historically the time and resources needed to maintain these programs were restrictive, many direct and indirect benefits to the practice now allow these programs to be viable and help all stakeholders within the practice. As evidence and approvals in genitourinary oncology continue to expand, it is important that institutions that have research or advanced therapeutic capabilities consider entering the clinical trials space to continue to be advocates for our patients and provide contemporary and conscientious care.