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The conflict over clinical trial costs has been a controversial issue between study sites, sponsors and clinical trial industry experts. While there are many factors that attribute towards increasing costs, this discussion involves a matter of perception regarding clinical trial business activities.
A research study conducted by the Society for Clinical Trials indicates that clinical study operations at the site have become overly lengthy, requiring a significant amount of resources from study sites . Moreover, the research study suggests that study sites are unable to accurately estimate resources involved with implementing clinical operations, and oftentimes underestimate resource costs.
When this topic was run across study site managers and sponsor personnel, many expressed their perspectives around how they view increasing clinical trial business operational costs.
The Study Site’s Perspective
When study sites were asked how they viewed ‘unseen’ or ‘hidden’ clinical trial business operational costs, study site personnel indicated that they deal with growing workload per study, and that the sponsor is not compensating them appropriately for increasingly demanding study activities. Study sites frequently breakeven on their clinical trial operational activities, and no sites boasted about weaning business profitability associated with executing clinical trials. Some of the hidden/unseen activities that sites expressed concerns with include a lack of efficiency associated with the implementation of different EDC systems, requiring frequent learning curves and resulting in reduced productivity. Other resource consuming activities included collecting & reporting AE/SAEs, prescreening activities, preparing for monitoring visits, addressing post monitoring queries, scheduling subject visits, the time it takes to obtain source documents and patient medical histories, CRO monitor staff turnover resulting in repeated monitoring activities, and inconsistent site startup operations that require the site to re-submit regulatory documentation. Some sites feel, with the increase in outsourcing, that site clinical research agreement budgets have been cut in order for sponsors to compensate CROs for their activities. Some sites have gone as far as halting enrollment activities due to low study budgets and untimely site payments.
Study sites have expressed that that there is a lack of sponsor-site interaction, which is resulting in a relationship disconnect, where sites feel unheard, and sense that they could not bypass the CRO to reach the sponsor when expressing concerns.
The Sponsor’s Perspective
From the sponsor's perspective, surging clinical trial costs associated with sluggish business operations has forced many sponsors (particularly large ones) to resort to the outsourcing model  in order to realize scalable efficiencies in clinical trial execution; outsourced activities include contract negotiation and site payments.
When it comes to structuring study budgets, sponsors oftentimes utilize a template budget that delineates generalized, yet, structured clinical trial reimbursement platform that is integrated with EDC. Study budget templates tend to include reimbursements for study startup, close-out and IMV units, subject visit completion units in EDC (regardless of the amount of queries/subject visit), and reimbursements for advertisements. However, most sponsors do not delineate units that reimburse sites for hidden/unseen activities as outlined previously.
In addition, sponsors tend to take a risk-averse approach, when reimbursing sites. Sponsors tend to keep budgets within specific financial guidelines, as they believe that they need to adhere to fair market value, and they do not want to be perceived by neither the FDA nor the public as favoring certain principal investigators or issuing kickbacks.
These differences, in combination with the distancing that has resulted from the outsourcing model, may have created the misperception between sites and sponsors around higher clinical trial costs. Sponsors allocate significant amounts of capital on enrollment activities, such as advertising and marketing campaigns, believing that such activities would boost enrollment. Nonetheless, sponsors have ignored some of the true factors that are associated with enrollment, such as sites forgetting about a protocol and a lack of site motivation towards enrolling in a specific clinical trial due to low budgets and high business operational activities.
What Could Be Done to Address this Gap?
1. Sponsors Should Understand How Study Sites Feel: Exploratory & Survey Research
A large accountability of outsourcing entails the fact that sponsors must appropriately oversee CRO activities. While clinical trial quality is a big facet that many sponsors focus on, sponsors tend to overlook how sites feel. Implementing in-depth and survey research with analytical interpretational expertise allows the sponsor to better understand how a site feels, and uncovers specific trends that would be useful for maximizing the effectiveness of site activities. For example, a sponsor could perform a regression analysis on high or low enrolling sites with responses to survey questions, such as how satisfied sites are with the CRO’s activities, do site study budgets reimburse them appropriately for their activities, and whether a site has forgotten about the study.
2. Site Staff Should Measure Resources and Invoice the Sponsor for Unseen Activities
Like sponsors, study sites need to generate a profit to sustain business operations. In order to leverage their position, study sites should document activities involved with running clinical trials. For instance, study sites should document and estimate the time and resources to implement hidden/unseen activities, and convert such measurements into invoiceable financial figures. Moreover, study sites should work with the sponsor around how they could structure such reimbursements to be included in clinical research agreements.
3. Sponsors Should Redesign Study Budgets to Include Reimbursements for Unseen Activities
Subsequently, sponsors should figure out ways in which they could re-design their clinical research agreement budgetary structure to reimburse sites for their hard work, while maintaining efficiency and abiding by federal regulations in executing clinical trial payments.