July 2019 | Richard Malone, PharmD, MHA
I remember my sense of surprise when I jumped into the clinical research arena full-time several years ago. Having spent over 15 years incorporating cutting edge technology and analytics into my clinical and administrative roles in pharmacy practice, I was relatively shocked by the volumes of paper littered with handwriting of varying degrees of legibility contained in our site study binders.
The transition from paper to electronic documentation in clinical trials had been moving at a proverbial snail’s pace since its inception in the early 2000’s. In fact, less than half of some important outcome and study data elements were captured electronically 10 years after the journey began.
Scope and effects
The slow adaptation of technology to reduce manual documentation and data collection in clinical trials is just one byproduct of a larger, risk-averse culture that has sought comfort in the security of the status quo. Use of innovative approaches to participant recruitment, monitoring, and retention as well as site monitoring have been slow to become commonplace as well. While the rest of the tech world has seemed to advance at the speed of sound, there has been a relative crawl in the research community. Trials are still unnecessarily slow and inefficient leading to drugs and devices that are too expensive for sponsors and often too late for patients. Review of applications to the FDA for drug approval can often include over 100,000 pages containing countless data points and can take over two years to complete. The estimated cost to drug companies is $300,000 per lost week of patent life while the cost to patients cannot be measured in currency.
Changes on the horizon
The good news is all is not gloom and doom. Today’s concerted rush of effort to push technological advances into clinical trials is unprecedented. Every conference agenda is filled with buzzwords and catchphrases such as paperless clinical trials, blockchain, wearables, using real-world data, disruptive technology, and risk-based or remote monitoring. A personal favorite is “emerging technologies”, which seems better suited to read “technologies that the rest of the world uses, why don’t we try them?” There’s no doubt that the need is real and the push is on, so rapid education of the clinical trial community regarding available technologies is needed. Vendors play a key role in developing, marketing and educating partners about solutions that can create win-win-win scenarios for themselves, sponsors, and patients.
McCreadie Group and Vestigo® offer solutions
McCreadie Group’s (MGI), Vestigo software automates Investigational Drug Service processes improving compliance, accountability, safety, and efficiency in over 85 organizations, including the majority of top NIH funded institutions and NCI designated cancer centers.
The capabilities of Vestigo also offer benefits to sponsors, CRO’s, and IRT providers. 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 destructions in real-time, preventing data entry delays, duplication, and errors. Additional functionality of the software could provide support to centralized, remote, and risk-based monitoring efforts. Partnerships between clinical trial teams and MGI can decrease pharmacy staff time spent with monitors as well as improved efficiency, reduced CRA travel time, and lower expenses for the CRO.
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.