With all the exciting developments occurring in cancer research, community oncology practices that currently do not offer clinical trials to patients may be considering executing a research program.
Bharat Patel, MBA
With all the exciting developments occurring in cancer research, community oncology practices that currently do not offer clinical trials to patients may be considering executing a research program. Before moving forward, it is important to carefully consider what is required to successfully implement a program, as well as challenges that may be encountered.
To succeed in clinical research, a community practice needs a robust patient population. The practice should be well established so that research activities do not hinder the overall success of the practice (Figure).
Another critical factor is the level of interest of the site research leader and other physicians. Within US Oncology Research, the research arm of The US Oncology Network, the level of clinical trial participation varies from site to site. The difference usually lies in the amount of the research leaders’ involvement and the practice physicians’ interest in making clinical trials available to patients.
The practice’s financial strength also is a key ingredient of success. Historically, clinical trials have been financially challenging, although there are ways to budget for an active program that do not overstress the finances of a practice. US Oncology Research, which is a network of independent clinics, has a budget model that can help guide practices. Generally, if an organization is not financially healthy without clinical research, a clinical trials program may not be feasible, and caution is advised.Community oncology practices that are well positioned to execute a clinical research program will realize many benefits. Practices have access to innovative treatments under development, which, in turn, enables them to offer cutting-edge therapies to patients who otherwise would have to travel long distances to participate in a trial. Practices also gain access to novel therapies early in development, and physicians become familiar with the safety profiles and efficacy. That positions them for success in the use of those agents should they come to market.
As a community oncology practice weighs the value of becoming a clinical research site, several factors need careful consideration:
Physical space must be dedicated exclusively to research.
The starting point involves allocating a dedicated space to research activities. Although not all centers have a physically separate area for research-related infusion, they should have dedicated real estate in the office for clinical research functions. In addition, that area should house all things related to clinical trials, such as investigational products, lab kits, and other necessary equipment.
Physicians and staff must be knowledgeable about clinical research.
Physicians―especially the primary investigator at the site―must have a thorough understanding of the complexities involved in running a program, gained through either education or experience. Research staff also must be highly trained and competent in their respective areas to ensure the team is adequately prepared to conduct trials, with patient safety as their top priority.
Human resources are required.
Key personnel are needed to efficiently run research programs and meet regulatory obligations. A primary physician investigator is mandatory. Other necessary personnel include a clinical research manager to oversee trial execution, a clinical research coordinator (typically, a nurse who assists the physician), a data coordinator, and a pharmacist.
Various support functions require access to other key personnel, such as a finance person to help establish budgets and legal expert to execute contracts. For practices in The US Oncology Network, these functions are handled centrally, enabling them to concentrate on research rather than administrative tasks.
All the above elements are necessary, because they instill confidence in pharmaceutical companies that physicians and staff understand how to run clinical trials and that the facility has adequate resources to execute a quality trial and produce the data necessary to answer clinical questions— all while keeping patient safety at the forefront.Opening a clinical trial can be daunting. Establishing contracts with pharmaceutical companies, developing a budget, managing the operational logistics, and meeting regulatory requirements are by far the most time-consuming activities.
Once the trial is open, patient accrual becomes a priority. Matching patients to the eligibility criteria is challenging in today’s evolving world of oncology research, particularly with targeted therapies being a major focus. Pharmaceutical companies want sites to enroll as quickly as possible, because this can get the drug to market—and to patients—faster. Unfortunately, identifying and enrolling perfect matches can be a difficult, slow process.
As a trial progresses, ensuring that data are high quality becomes a major concern. Huge volumes of data are generated, entered into a database, and submitted for review. The site must make it a priority to make sure that all appropriate data are entered. As pharmaceutical companies review the material, they typically send hundreds of queries back to clinics. Responding to these is labor-intensive and must be completed so that trial sponsors have all the necessary information to conduct analyses in preparation for clinical study reports for the FDA.Making clinical trials an integral part of daily care delivery starts at the top. For a program to succeed, the site research leader must demonstrate to colleagues the importance of research. If the research leader and physicians are not fully engaged, the practice needs to determine if they are conducting the right trials for their patient population. Having discussions about the type of trials the site needs or wants can encourage involvement.
Integrating trials into the workflow is often a matter of creating awareness so that physicians know which trials are open and applicable to their patients. This is challenging in large practices where many trials are available. A technology solution that puts trial information in the palm of the physician’s hand, coupling patient information with open trials and eligibility criteria, may be the answer.Community oncology practices are making a tremendous contribution to clinical research. For example, US Oncology Research, comprised exclusively of community-based, independent practices, has developed a unique recruitment model—the Selected Trials for Accelerated Rollout (STAR) method—that opens and activates clinical trials quickly across all 60 sites and 165 locations within US Oncology Research. When a STAR patient is identified, the study is opened within 2 weeks at the location where the patient will be treated. This innovative recruitment tool is enormously helpful in broadening the reach of research in community oncology, playing a critical role in getting promising new treatments to patients as fast as possible.
Community oncology practices are also capable of conducting complex phase I trials. US Oncology Research, for instance, has 18 sites that offer phase I trials, bringing novel therapies into local communities so that critically ill patients do not have to travel to large academic institutions for treatment.
Community oncology’s role in clinical research will continue to grow, and its contribution to advancing cancer care will be significant in the future. Because many cancer patients in the United States are treated in outpatient settings, community oncology practices are the cornerstone of oncology care, making clinical research in community settings extremely relevant.