The Changing Environment of Research
With the advancement of medicine over the past several years, it is no surprise that clinical research has become more complex. In conjunction with these advancements, hospitals and health systems are making significant changes to their research operations.
At the forefront of these changes is growing pressure to conduct more research. This pressure has escalated from competition among providers to deliver cutting-edge care with the latest medications and devices. Institutions are beginning to use their participation in innovative research to bolster their public image and attract the community. Subsequently, hospitals and health system are striving to attract the brightest minds in the medical field.
There is also a growing trend nationwide to purchase physician practice groups, driven by the desire to better position themselves in new CMS reimbursement model. Many times after these purchases are finalized, organizations come to the realization that there are research activities buried under normal business operations. Oftentimes those within the practice group do not realize the full extent of these ongoing research activities because clinical personnel are performing research in addition to their normal clinical functions. These personnel are frequently unaware of changes in regulations or guidelines, nor are they typically experts in research operations. Both factors can put the system at considerable risk.
Further risk has arisen from heightened scrutiny with regard to research billing compliance. There is a growing need for systems to develop process that prevent double billing, in which funds are received from both the study sponsor as well as government or third party payors.
Among increased scrutiny and changing regulations, more and more institutions are being cited for improper billing practices. In fact, many well-known medical centers and health systems have been fined millions of dollars for these practices over the past decade. One way in which institutions can manage these risks while also fostering clinical innovation is by adopting a centralized clinical trials office (CTO).
Advantages to a Centralized CTO
Above all, a centralized CTO allows institutions to streamline their research operations. Centralization also provides an opportunity to optimize research resources. In many decentralized models, the same tasks are performed by as many as five people, some of whom do not have the proper training. A centralized model allows one or two experts to perform the exact same function in a consistent manner. Centralization can also help foster communication and prevent small bureaucracies that tend to form within departmental silos.
Further efficiency is gained by allowing research coordinators to focus more on clinical and screening activities. Taking many of the administrative duties off of coordinators, such as study start up activities and regulatory support, allows them to be significantly more productive in patient recruitment. In nearly every transition to a centralized model, institutions experience increased enrollment, higher quality of care and increased coordinator satisfaction.
Better outcomes related to compliance and FDA visit readiness also improve greatly with centralization, as regulatory and compliance issues can be stopped before they reach a critical point. This is particularly advantageous in today’s environment of increased oversight.
Though centralizing a CTO cannot take place overnight, taking the time to do so promotes greater efficiency, better communication, and more streamlined research operations in today’s changing environment of research. There are many factors to consider and decisions to make before moving toward a centralized model. Accordingly, it may be worth considering a third party to assist with the transition. While no two CTOs operate in the same manner, all can undoubtedly benefit from centralization.