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International Clinical Trials

Automatic Drive

In clinical research, slow payments to investigative sites can be costly. Manual payment processes, in particular, are not only time-consuming and error-prone, but also limit the ability to accurately track financial progress of a trial and hamper the ability to forecast upcoming costs.

Automated payment systems tie electronically collected data to negotiated contract payment terms and milestones. In so doing, automation can eliminate cumbersome manual invoicing and payment processes, while allowing sponsors to better project future expenditures. Automation also has several benefits beyond payment metrics, including site satisfaction, improved transparency, and better accuracy related to data-driven clinical trial performance.

Manual Inefficiency


Manual payment systems are multi-step processes that can lack transparency, leading to uncertainty for both investigative sites and the sponsor or contract research organisation (CRO). This is illustrated by the experiences of one sponsor and its manual, paper-based system. The process of payment was initiated when the site sent a monthly invoice to the sponsor. Upon receiving the invoice, sponsor personnel checked whether the calculations were correct. Often they were not because the site had erroneously calculated the payment amount due to the manual nature of the process. The invoice was sent back to the site for correction and reissuance of the invoice, which resulted in a delay in processing it and, ultimately, a delay in remitting payment to the site.

Once the invoice calculations were finally accepted, sponsor personnel accessed the electronic data capture (EDC) system of record to confi rm that the subject visits were conducted and documented properly. Finally, a site monitor source verified that the invoiced procedures had occurred. In all, the sponsor had three layers of confirmation before payment was issued.

They went through this process for every single site, every single month. In the context of trial execution, the amount of time and effort used was significant for both the site and sponsor because the resources could have instead been applied to activities critical to the trial’s primary outcome.

Lack of Immediacy

The ramifications of having complex, redundant processes went beyond excessive resource commitment. Submitting payments to sites only once trial monitors conducted on-site visits meant that sites had little incentive to enter subject and procedure data until just before their scheduled monitoring visit. This prevented the sponsor from having immediate access to data when services were performed and a real-time perspective of how the study was progressing.

Given the amount of time between invoicing and receipt of payment, sites frequently have concerns as to whether their invoices are being processed and whether cheques have been issued. Their concerns result in calls to the project manager or lead, who then tracks down the status of payment.

Automated Incentives

In contrast to manual payment processes, automated payments are data-driven and electronically triggered by the information entered into EDC or other eClinical systems by site personnel. The gains in efficiency are particularly relevant for complex later-phase trials, which potentially involve hundreds of sites, a long list of subject procedures and evaluations, and protocol amendments.

Receiving payments based on electronic data entry provides an incentive for sites to keep subject records up-to-date. This increases data quality and improves the sponsor/CRO’s ability to track trial progress and identify any potential issues in real time. Consequently, the time and energy spent on questions related to invoicing and payments drops dramatically throughout all phases of the trial.

Given how critical sites are to achieving the primary endpoints of a study, their time is better spent focusing on subject enrolment than in tracking down payment-related issues and discrepancies. For sites conducting multiple clinical trials, having a more predictable cash flow also allows for increased investment in infrastructure – for example, staff, training and equipment – improving efficiency across all the clinical trial activities that are ongoing, which may provide the tools and time necessary to take on additional trials.

Process Flexibility

Sponsors/CROs have historically tried to keep the payment process as similar as possible among sites for ease of management. This is because having different payment terms for each site is complex to manage and leads to challenges in making sure individual sites are paid accurately and timely. Add in contract amendments that are negotiated with different terms and effective dates, and the management of a unique site contract becomes cumbersome at best.

Automation allows sponsors/CROs to apply different conditions for every single visit, procedure or milestone for each site. This gives sponsors/CROs ultimate flexibility in designing payment processes. For example, screen failure payments can be managed in an automated manner, based on established criteria. A sponsor that traditionally may have only paid sites for five screen failures at the end of a trial as it was not able to predict overall site enrolment might decide instead to pay for five screen failures in an ongoing manner as study criteria are met, such as after the site has randomised two subjects or only after the site has screened 12 subjects.

Financial Monitoring

When sponsors/CROs have no method for accurately viewing the actual number of subjects and their progress through the study, it is a challenge to accurately forecast how much money will be needed to fund the study in upcoming months and quarters. This is a critical component to understanding upcoming expenditures in R&D efforts.

Automated payments allow sponsors/CROs to view their ongoing costs and accruals for the study in real time. Once services are performed by site personnel and entered into EDC, the related accruals and due dates are immediately visible in the automated payment system. This facilitates budget transparency for the ongoing study, as well as future studies.

Good Relationships with Sites

Between the mid-1990s and the mid-2000s, a massive expansion in the number, complexity and duration of clinical trials led to a shortage of sites in the US and Western Europe (1-3). While many sponsors/CROs responded by expanding their operations to Central and Eastern Europe, Asia and South America, more than half of all clinical research is still conducted in North America (4).

Thus, competition for experienced sites that have access to subjects and are actively enrolling can be fierce. The competition comes during an era of decreasing personal interaction between sites and sponsors/CROs as increases in centralised monitoring has replaced, in some cases, in-person monitoring visits and direct site interactions. In selecting trials for participation, principal investigators may not be personally invested if the personal connection is absent, and subsequently may opt to base decisions on whether they will receive timely and accurate payments that save their staff or personnel administrative time.

Operational Concern

A 2012 study reported that more than one-third of sites in North America wait more than 90 days for payments (1). In contrast, research sites pay most of their operating costs within 30 days. Operational expenses occur daily when running a clinical trial; so it is little wonder that a 2009 CenterWatch survey suggested that investigative sites’ most important operational concern is slow payments (5,6).

The perception that sponsors/CROs will pay in a timely manner is important to ensure that sites join a trial and that they remain committed to enrolling subjects. Results from a survey of more than 150 studies at 16,000 sites globally indicate that 11 per cent of sites in a given trial fail to enrol even a single subject, and 37 per cent of sites under-enrol (7). With the amount of resources invested to start up a site, enthusiasm for enrolment during the study is an important investment for both the site and sponsor/CRO.

Final Thoughts

Automated payment systems are about more than just reimbursing study sites quickly – they help ensure the amount sponsors/CROs pay for conducting the study is accurate and that sites are compensated for work as it is completed. With the drug development industry spending billions of dollars to improve or save patients’ lives, resources should be used in the most cost-effective and efficient manner.

References
1. Koreith K and Anderson A, Global sites see growth in trials, revenue, staffing, The CenterWatch Monthly 19(4): pp1,9-14, 2012
2. Califf RM, Filerman GL, Murray RK and Rosenblatt M, The clinical trials enterprise in the United States: a call for disruptive innovation, Institute of Medicine of the National Academies, 13th April 2012. Visit: www.iom.edu/global/perspectives/2012/callforCTE.aspx?page=8
3. Growing protocol design complexity stresses investigators, volunteers, Tufts Center for the Study of Drug Development, Impact Report 10:1, 2008
4. Investigative site landscape remains highly fragmented as the number of active investigators worldwide reaches an all-time high, Tufts Center for the Study of Drug Development press release, 12th March 2013. Visit: http://csdd.tufts.edu/news/complete_story/ir_pr_mar_apr_2013
5. Goldfarb N, Solving the revenue collection problem for clinical research sites, Journal of Clinical Research Best Practices 9, 2009. Visit: http://firstclinical.com/journal/2009/0909_collections.pdf
6. Klassen P, The investigator as a trusted partner, Food and Drug Administration Clinical Investigator Training Course. Visit: www.fda.gov/downloads/training/clinicalinvestigator trainingcourse/UCM343984.pdf
7. New research from Tufts Center for the Study of Drug Development characterises effectiveness and variability of patient recruitment and retention practices, Tufts Center for the Study of Drug Development. Visit: http://csdd.tufts.edu/fi les/uploads/02_-_ jan_15,_2013_-_recruitment-retention.pdf


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Heather Schultz is Vice President, Operations, at Clinverse, Inc, and has more than 16 years of clinical research operations experience. She previously served as Senior Director of Global Training at PPD, as well as in roles including Senior Project Manager, Associate Director and Director of Project Management in the endocrine, metabolic and immunology therapeutic areas. Heather has a Bachelor’s degree in Biomedical Science from St Cloud State University.


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