Article-

6 Considerations Affecting the Value of Your Centralized Clinical Trials Office


By Sean Rinehart, Director of Transformation & Process at PFS Clinical, David Russell, Director of Strategic Accounts at PFS Clinical and Geoffrey Schick, Senior Consultant of Site Strategy at PFS Clinical

Over the past few years, academic medical centers, integrated healthcare delivery systems and larger regional health centers have begun making the decision to centralize the administrative functions of clinical research.

Centralized coordination allows institutions to improve billing compliance, streamline budgeting and contracting procedures and facilitate financial administration of studies. Centralized offices also give sponsors a more consistent experience with respect to start-up processes and provide an operational leadership function for streamlining administrative activities across the organization. Simply put, they make sense.

Along with the benefits, there come challenges with implementing these centralized functions. When not addressed, they can limit the value that central offices ultimately provide by minimizing a central office’s attention on improving subject enrollment, enhancing population readiness, aligning research/ physician incentives, enabling good clinical practices across the department and strategically developing a competitive research portfolio. The following is a closer examination of some of these challenges:

1. Staffing for Billing Compliance

The nature of the work in central research offices can make appropriate staffing difficult. Determining payor coverage in the context of items and services within a protocol is time intensive and technically challenging to automate. To develop one (or more) individuals who can efficiently determine payor coverage typically requires at least 3-5 weeks of focused training along with 3-9 months (depending on the type of study) of extensive quality control. Once in place, their skills can quickly position them for more lucrative career opportunities, leading them to leave before offices can realize return on their training investment. Because most studies coming through the office require such an analysis, this process can be a limiting factor in terms of overall throughput; thereby slowing down budgeting efforts and even contract execution. Finding ways to improve productivity and reduce risk in this function can help an office provide a more consistent experience to its stakeholders.

2. Turnaround Times

Ever have a contract that’s taken more than 3 months, 6 months, or even a year to be executed? Everyone has had this frustration. Delays can be caused by limited access to signature authority, low institutional risk tolerance, or lack of confidence in negotiating internally with physician researchers. Regardless, this leaves investigators frustrated and ultimately limits options for potential subjects. Finding ways to reduce the time from initial contract redline through negotiation without undermining an institution’s risk objectives can make the study start-up process a more reasonable experience for research teams. Technologies such as electronic signatures can take days or weeks off execution times. A quick, decisive administrative turnaround builds confidence that the institution is there to support the research office and the investigator. Coupling this with effective enrollment can help make an institution attractive to sponsors as well.

3. Volume

New study volumes can vary throughout the year, but the fixed costs of employees stay the same or rise over the same period. Although low volumes are not typically a processing problem, excess demand can be, as it affects everybody in the queue for services in terms of turnaround times and quality. Having a way to accommodate excess demand without having to train additional resources will improve the ability to ensure that investigator are getting their studies started in a predictable manner. Furthermore, a centralized trial office that takes an active role in managing the study pipeline can help prevent those ebbs in volume.

4. Efficient Financial Negotiations

The more studies an institution conducts, the more proficient it gets at budgeting and negotiations. Offices that are networked with their peers who conduct the same services at other institutions can share best practices. While it would be helpful to know what other institutions are getting per-patient or for overall start-up costs on studies, investigating this can take time. Finding ways to identify and adopt best practices with respect to policy, budgeting and negotiations can have a major impact on operational cost recovery. Additionally, the cash basis accounting used at many institutions invariably leaves money on the table, unclaimed from the sponsor. This can be caused by a failure to invoice the sponsor or shortcoming in the reconciliation of payments to determine what money is missing. Accrual accounting can help remedy this by uncovering lost revenue, which is demonstrated in a case study on these practices at Wayne State University. Unfortunately, institutions often do not have the bandwidth to facilitate this transition.

5. Quality of Service

With demands for tighter turnarounds, there may be situations in which quality checks on payor or budget analyses are below standard in favor of timeliness. This may satisfy study teams in the short term, but cause problems later when financial and billing teams are trying to execute their processes and recover their costs compliantly. Finding ways to build more flexibility into the research department’s capacity may put less pressure on the other processes that ensure a high degree of quality in start-up deliverables.

6. Return on Technology Investment

Finally, many institutions have found it necessary to make well-intentioned investments in clinical trial management systems (CTMS), along with EHR and other ERP system interfaces. However, the promised gains often go unrealized due to a lack of staff and/or training in regards to CTMS functionality. Studies need study calendars and financial milestone enablement to facilitate sponsor invoicing, but building these takes time and training. Often central offices do not have funding for the staff required to do this for every study, nor the belief that training study coordinators to do it would meet a consistent quality standard. As a result, these systems languish; used only in the stage of simple subject enrollment and status tracking, without the next step of understanding participant progress in the study protocol. The latter is then maintained in various Excel spreadsheets by departmental administrators who are using the information to collect from sponsors. The CTMS becomes an expensive beast that is underutilized, adding work and costs to the overall process without the corresponding efficiencies. It may be difficult to gain momentum with a CTMS because study start-up volumes drain most of the strategic bandwidth of existing resources. For organizations in this situation, finding ways to transition to the new system without incurring additional fixed overhead cost can get the organization on the path to realizing the promised return on its investment.

Some of these issues may speak to some organizations more than others. The key takeaway lies in how a central office wants to deliver value to its stakeholders. There are varying opinions, but this usually comes in the form of a consistent experience of reasonable turnaround times for startup, delivering a quality set of services regardless of demand levels, where the cost of delivery can be nearly fully recovered on average, but there is still time for strategic and tactical process improvements. Strategies can vary, but a first step may be finding ways to transform certain fixed costs into variable costs. This can be done by finding partners to add capacity when needed or to provide delivery of services on the institution’s behalf within its terms, specifications and exposure tolerance. There are partners out there who can help reduce the costs and risks of delivering coverage analyses, study budgets, contract reviews and related negotiations. Some of these partners also provide support for financial administration, research encounter adjudication and CTMS enablement, among other services. Often the cost for these services can be recovered from sponsors, making the net financial impact small while realizing all the benefits of improved turnaround times and equal (or better) levels of quality. Finding the right mix of partnered services can help research departments meet or exceed their goals, freeing up resources to focus on matters of even more value to the research enterprise.