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.
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.
Figure. Resource Basics for Successful Clinical Trial Management
Research Provides Many Benefits
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.
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.
Clinical Trial Challenges
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.
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