The Burden of Regulatory Compliance
By Richard Wagner
While there are obvious pressing logistical and operational challenges, there is also a tremendous amount of data that needs to be collected and managed during the course of a clinical trial. Not only is this data needed for the outcome of the trial itself, but it is also necessary for managing site regulatory compliance.
In a recent survey1 by CenterWatch, the clinical trial research company found that while half of the respondents said their site was on schedule when it came to the maintenance of regulatory tasks prior to an audit or monitoring visit, 28 percent were almost a week behind and 14 percent were two weeks behind. The reason for the backlog is because data tracked on paper can often fall to the wayside as a trial is being conducted until someone has the downtime to enter it into the relevant clinical data systems. This causes sponsors and/or supply managers to lose valuable visibility into what is going on at that site. Paper records begin to accumulate, and sites are soon faced with trying to find a place to store them along with the supplies.
At the end of the study, all of this information in paper records has to somehow come together into a complete chain of custody records that regulators will need access to as questions arise. Every adverse event that is recorded during the trial needs to be investigated, in order to determine which are significant. Sponsors have an ethical and moral responsibility to protect the safety of the patient. When patients experience an adverse event, there must be absolute certainty that the right patient has been given the correct drug.
The data management burden in clinical trials is compounded by the high turnaround rate of clinical research associates and monitors. Most clinical trials can run for numerous years. If paper records and/or unanswered questions begin to pile up as a revolving door of personnel is turning, you could potentially run into a situation where you cannot provide answers to vital questions regarding your study.
A promising solution
In line with the growing awareness of the need to better record “source” data electronically, electronic systems and technology can be powerful tools in improving the fragmented nature of the current chain of custody management processes. Any proposed technology solution must meet the needs of several stakeholders, in order to be successful. Notably, the following goals are paramount:
- Reduce the supply management burden, both during the study and during study closeout, and reduce the possibility of a stock-out event at the site. The supply management team is also continually looking for ways to reduce the overall cost of producing, distributing, and tracking study medication.
- Eliminate medication dispensing errors and retain patients on the trial. Clinical Operations are also interested in optimizing the trial monitor workflow and time-on-site, as well as incorporating any available historical data into site selection processes and use ongoing site performance metrics to support risk-based monitoring programs.
- Preserve the flexibility necessary to accommodate unanticipated circumstances during patient care and to minimize the intrusiveness of the technology solution to delivering patient care. The site also wants an expedient and simple means for managing its inventory and meeting the accountability requirements of the study, while making the best use of potentially limited storage availability.
Introducing a system that can accomplish all of this and more could optimize the supply chain at every level. However, an ideal solution requires the support of both Clinical Operations and Supply Management. Both groups may have concerns about the implementation of a system such as this, and many are related to the potential disruption to established standard operating procedures. The key to designing and implementing a system that can be accepted by both teams and integrated into standard operating procedures more easily is to gain input from all stakeholders in the trial.
What stands in the way?
The pharmaceutical and healthcare industries are notoriously risk-averse. This is an understandable consequence of the critical nature of patient care and the potential risks associated with any errors. However, existing processes have, in many cases, evolved over a considerable period of time. Often, this may become more burdensome than desirable, while not contributing to any risk reduction or quality improvement. By implementing a more streamlined workflow with automated data entry and verification, costly and time-consuming processes, duplicate verifications and potential errors could all be reduced. Nonetheless, before you can begin the process of implementing this type of next-generation IRT system, you must first address any concerns of your stakeholders.
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1 http://www.centerwatch.com/news-online/2015/04/01/ regulatory-compliance-an-increasing-burden-on-sites/
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