Did you know…
- Protracted budgeting and contract negotiations constitute the biggest source of delays in the clinical trial process more than any other reason1.
- There is a general consensus among research sites that most study budgets are too low to provide adequate – or any – profitability. Yet most research sites have little or no understanding of their clinical research costs2.
- The number one thing sites would change about the way sponsors and CROs interact with them is for the sponsor to be more willing to consider the site’s requests for adequate reimbursement of the time and effort needed to conduct research3.
- Not only has the total number of clinical procedures increased, but the relative effort necessary to execute the average procedure has also increased4.
Combined with the complexities of Fair Market Value (FMV) requirements, there is a growing need, as well as pressure, for sites to understand, justify and provide documentation of the work effort involved in performing clinical research activities. Securing a better understanding of the true costs of conducting research:
- Helps ensure compliance with FMV obligations
- Enables better and more efficient budget negotiations
- Provides a significant opportunity for sites to improve their overall profitability
What are the true costs of conducting research?
In the absence of good supportive data, sites may underestimate the true work effort and, hence, cost involved in performing any given task. From a negotiation standpoint, this puts them at the mercy of sponsors and CROs who rely on industry benchmark services to justify reimbursement rates, which are often based on procedural costs rather than personnel costs. Case in point: sponsors may view the fees for performing an EKG as a stand-alone event and reimburse this based on a standard Current Procedural Terminology (CPT) code rate. This doesn’t factor in the support that goes into reading and interpreting the EKG, obtaining certified copies and principal investigator signatures, faxing in the results, responding to queries and the like, all of which may consume a significant amount of personnel time beyond the actual time to perform the procedure itself5.
To learn more about why and how to start effort tracking at your site, download Forte’s free eBook, “How to Conduct Valuable Effort Tracking at your Site.”
Fundamentally, the industry has suffered from the lack of a well-documented “time and motion” (TM) study to substantiate the true costs of conducting clinical trials. To do this, the basic process would involve systematically defining a set of standard tasks and then having personnel complete time logs over a given period (say, several weeks or months) to log the amount of time it takes to complete the tasks. The times are averaged across personnel and tasks to come up with a benchmark range for the most common set of research tasks. The few studies that have attempted to develop workload measurement instruments, model clinical trial workflow and document site work effort have suffered primarily from their small sample size, thereby limiting the generalizability of the data2 6 7. Nonetheless, these studies provide insight to the most time consuming tasks, as well as the wide variability across sites for any given task.
Why should sites document work effort?
Given what appears to be a compelling case for an evidence-based approach to documenting work effort, the real question is, why don’t sites do this? Basically, TM studies are perceived as burdensome and time consuming. While one study performed by Khan et. al. used a mobile application to ease the burden of documentation, historically these studies have involved significant manual effort.
Enter the new generation of clinical trial management systems (CTMS). These systems provide a great opportunity to streamline and automate the data collection process. While the process of performing a TM study requires dedication and discipline, the value proposition for an individual site to invest this time appears obvious. That said, given the variability across sites and the disparity between site and sponsor perceptions of work effort, it behooves all sites to commit to making this investment so that an industry-wide benchmark database can be developed. This would provide ALL sites with significant leverage in the budget negotiation process and go a long way towards educating sponsors and CROs about the true work effort involved in performing clinical research.
To learn more about effort tracking, view our on-demand webinar, “Work Effort Tracking and Management Revisited: The Need, the Value and the Process.”
Editor’s Note: This blog post was originally published on August 13, 2012.
1. 2007 and 2009 Thompson CenterWatch surveys
2. Goldfarb. Clinical Research Terminology Codes: What We Do and How Much it Costs; Journal of Clinical Research Best Practices; Vol. 2, No. 3, March 2006
3. 2010 Site Solutions Summary survey
4. Spotlight on Research Fees: Protocol Complexity; Journal of Clinical Research Best Practices Vol. 8, No. 8, August 2012
5. Harper and Williams. Demystifying Fair Market Value. The Monitor. August 2011.
6. Khan et al. Modeling Clinical Trials Workflow in Community Practice Settings. AMIA Symposium Proceedings 2006.
7. Coffee et al. A Workload Measurement. Applied Clinical Trials. August 2010.