November 2022 | Richard E. Malone, Pharm.D., MHA
Repurposing of “old” drugs has been an important part of pharmaceutical research for decades. Many researcher hours and a great deal of NIH dollars are spent annually trying to breathe new life into drugs that are no longer featured in commercials or exhibit halls. The concept was recently thrust into the spotlight as various older drugs were examined for their utility in the fight against COVID-19. Since leaving the front lines of executing clinical trials in the academic medical center setting, I have spent much of my time seeking ways to extend the repurposing concept beyond the drugs themselves and applying it to the technology used in supply chain management and monitoring.
Current State: Cutting Edge Molecules and Trial Designs…Dated Execution
I often use the lines, “The molecules we study are cutting edge, but the way we study them is archaic,” and, “Jetsons… meet the Flintstones” when describing how we conduct some aspects of pharmaceutical research. The management of investigation product (IP) is a prime example. Despite the availability of electronic solutions, the standard for documentation of drug management and accountability at sites is often still paper based. The sites that have adopted research pharmacy software solutions generally recognize benefits on the productivity and compliance fronts, but the benefits of leveraging the functionality and data overlap with other systems have yet to be tapped.
Sponsors, CRO’s, IRT providers, and other vendors employ various technology solutions that play vital roles in the execution of studies, but they often do so in silos. This can result in numerous inefficient processes. For instance, sponsors often ask site personnel to complete training and memorize access credentials for external platforms where they enter data that already lives in their site systems. The duplication of data is not only inefficient, but it can also lead to issues with data integrity and timeliness.
How about a recent example for which we’ve found a solution out of necessity? For decades, study monitors were flown to sites to gather information from study binders and other sources to assess compliance and complete the data set for study drug disposition. The onset of COVID resulted in the suspension of onsite monitoring visits and revealed how some ingenuity and “outside the box” thinking could keep trials moving. Monitors were able to leverage site systems, email, video conferencing, and other methods to collect information for remote monitoring visits. Remote monitoring visits were “a thing” well before COVID, but the percentage of remote visits and the depth of information acquired during them has significantly increased.
I could go on and on. I’m sure you have examples specific to your role running through your head now as well.
Why Not Rethink How We Use Existing Technology?
The aforementioned industry silos result in duplication of work and open the door for discrepancies in data at many levels. For instance, site pharmacy teams often enter the same data points in up to three locations (paper and/or electronic systems) to satisfy the compliance and regulatory requirements of a particular study. Duplication exists in documentation of labs, physical exam results, and other clinical information as well. These practices waste a great deal of resources and cause concerns related to data timeliness and integrity. There is no doubt that communication and cooperation among companies in the clinical trial space is needed to improve the efficiency of data collections and to ease the burden on sites.
Some Solutions in the Works
So how can we work together to reduce the site burden and improve efficiency? One method is to promote integrations between site and industry systems. McCreadie Group (MGI) has embarked on a journey to expand the functionality and scope of our research pharmacy software solution to improve the site experience as well as provide improved data throughput, integrity, and transparency for sponsors and their partners. How?
- – Our interfaces with site EMR and CTMS products have been improving workflows and saving time for our Vestigo sites for years.
- – We are now expanding the functionality of Vestigo to assist sponsors, CRO’s and IRT providers in providing an excellent site experience and other benefits. MGI can partner with research organizations to provide a secure, closed loop information exchange of clinical supply accountability information. Automated data feeds can track study product activities including receipts, dispensations, returns, and final disposition in real time preventing data entry delays, duplication, and errors.
- – Additional functionality of the software, we call Vestigo Verify Central, can provide support to centralized, remote, and risk-based monitoring efforts resulting in the potential for decreased pharmacy staff time spent with monitors, reduced CRA travel time, and lower expenses for the CRO.
MGI is certainly not the only technology provider working diligently to improve optimize trial efficiency. I speak to colleagues across the clinical trial space nearly every day that are on the same mission.
So, What Can You Do?
If you made it this far into my blog, then you are likely a stakeholder at some level of the clinical trial spectrum, and you can make a difference. So, what can you do?
Let’s start with the most important people in any trial… the participants. Whether you are a patient looking for a breakthrough in treating your disease or a volunteer earning a little extra income in an early phase trial, your ability to adhere to the protocol requirements of a trial is paramount. Technology should assist in increasing participant compliance and satisfaction. Successful trials rely on you reporting failures in design and/or education related to virtual training, monitoring devices, electronic patient diaries, and other electronic solutions. Please give feedback to your medical team on how they can help to make your experience and outcomes optimal.
CLINICAL TRIAL SITES
Next up… clinical trial sites. Technology can and should assist you in completing your work in a more efficient and compliant manner whether you work for an academic medical center, a physician-based practice, a vendor supporting decentralized clinical trials, or some other “site.” If you experience inefficiencies, tell the sponsors and their technology partners where the gaps are, and how you think they can close them. Sponsors and vendors are becoming increasingly site centric and are willing to listen to your ideas and feedback. Take the time to share your thoughts with them.
Let’s round this out with the obvious stakeholders… sponsors and their partners. Pharmaceutical companies, cooperative groups, government entities, and other sponsors have the duty to work with their CRO, IRT, and supply partners to optimize the use of technology to reduce the burden on sites and trial participants. We need to be proactive in our efforts to identify opportunities to improve current solutions and create innovative new approaches to using technology and existing data sources. As an industry, we must also be receptive to analyzing and responding to feedback from sites and participants.
Continued creative thinking, innovation, and breaking down of walls is needed to bring full utilization of available technology into the clinical trials arena. The combined efforts of sponsors, CRO’s, IRT providers, vendors, study sites, regulatory bodies, and patients will be needed to drive the cost savings and efficiencies that technology has to offer. I work every day to think of ways we can use technology in new ways. I welcome you to connect with me and share your ideas on how we can improve clinical supply management and monitoring.