David Russell

	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 the 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 as well as attract the brightest minds in the medical field.
	
	There is also a growing trend nationwide for health systems to purchase physician practice groups, driven by the desire to better position themselves in the new CMS reimbursement model. Many times after these purchases are finalized, organizations find 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 processes that prevent double billing, in which funds are received from both the study sponsor as well as government or third party payers. 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).
	
	

	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 many transitions 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.
	
	

	One of the primary functions of centralization is to provide start to finish administrative support for investigators and their teams conducting research. Centralization also provides oversight of an institution’s responsibility to properly engage sponsors in clinical research by performing a coverage analysis for each applicable study and negotiating clinical trial agreements and study budgets. Financial oversight of all research operations, such as sponsor invoicing, collections, and tracking of federal funds, are also important functions of a centralized CTO.
	
	Another crucial function is the delivery of training and education to research personnel. Key stakeholders and others who are peripherally involved in research such as pharmacy and lab personnel should also be included. This allows everyone to be informed on industry changes, as well as updates within the institution.
	
	Generation and implementation of comprehensive research policies and standard operating procedures (SOPs) to be used across the entire enterprise are also important steps that mitigate risk and allow for more streamlined operations.

	To illustrate the value of a centralized model, consider the following example of a Midwest community-based health system. This institution had been operating with a decentralized model, but was seeking information on how to improve their research department.
	
	A review of their existing operations revealed several problematic practices. To start, there were no SOPs for conducting research across the entire enterprise. Although this may be surprising, it is not entirely uncommon. Next, over 40% of previously executed CTAs and budgets were found to be missing standard subject injury language. While more and more sponsors leave subject injury out of the CTA to save money, it is critical for the institution’s protection. Additionally, over 60% of the budgets were missing key budgetary line items, such as administrative start up fees, payment for time spent on monitoring visits, and IRB fees. There was also no process in place to prevent the act of double-billing research related items, which, as mentioned earlier, is a growing risk that can bring large Medicare fines, as well as unfavorable public media.
	
	The financial health of the research efforts were further affected by the lack of a tracking mechanism for ongoing research activity and revenue. Many institutions simply recognize revenue as the payments come in, but that can lead to a significant amount of money left uncollected. Without dedicated financial resources, these tasks often fall to research personnel who do not have the time nor knowledge to handle the revenue cycle and collections with the same rigor as other key departments receive.
	
	

	There are five key questions that every organization should consider when thinking about centralizing.

		How can our current established structure most optimally support and oversee our entire research operation?

		Do we have the appropriate resources to ensure a competent and compliant research operation?

		How can we serve our research efforts in the most effective and efficient way?

		Is technology properly supporting our clinical trial delivery?

		Are we continually looking for ways to improve our processes and performance?

	After consideration of the aforementioned questions, it is important to establish the need for centralization. Data and real life examples must be collected to demonstrate how forming a centralized department for research will reduce compliance risks and be a cost savings to the organization. In order to derive an accurate account of current risk factors, an extensive assessment must be performed in all key areas. Once this information is obtained, it should be shared with key decision makers, leaders, and physicians involved in research.
	
	Doing the due diligence process of gaining this information, building a plan, procuring support and presenting the data can be a daunting task. Using an outsourced partner can provide certain benefits, including the due diligence and plan, provide unbiased third party assessment, as well as oversee the transition process to centralization. An outsourcer can also work in a partial partnership with internally-identified experts to help in overflow situations due to high volumes, competing priorities, or if specific unusual circumstances arise.
	
	

	When moving toward a centralized model, there are several factors to keep in mind. To start, it is crucial to focus on customer service for the Principal Investigators (PIs) and their research teams. Simple ways to do this include reaching out to the PI to find out which studies are priorities to them or their patients and meeting with them monthly to ensure you are satisfying their needs.
	
	Communication is another key factor when it comes to the research team. They are the greatest asset of any research department and the first line of quality and patient satisfaction.
	
	It is also critical to ensure that the quality of work coupled with turn-around times have improved. Tracking and reporting key metrics that show areas of improvements grants the ability to demonstrate the correct decision was made to centralize. Accurate financial data per study should also be tracked in order to show key stakeholders the specifics on each study. This information is valuable when looking at overall profits and losses of the research department.
	
	

	Though centralizing a CTO cannot take place overnight, taking the time to do so promotes greater efficiency, better communication, and a more streamlined research operation. As discussed, 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.

, CRCP, Director of Strategic Accounts, PFS Clinical

Articles

Hospitals and health systems are making significant changes to their research operations in conjunction with the increasing complexities of clinical research. Adopting a centralized clinical trials office (CTO) can greatly assist in managing these changes.

David Russell

Articles

Centralizing Your Clinical Trials Office