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Applied Clinical Trials
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The Risk-Based Monitoring platform, OPRA- Operational Platform for Review, Reporting and Analysis, has been developed by Triumph Research Intelligence (TRI), based in London, UK and Raleigh, USA. OPRA employs a unique combination of statistical calculations, data visualizations and operational activity management to fill a long existing regulatory gap in the market. This gap has been driven by regulatory requirements surrounding the RBM approach that the clinical trials industry has been in the process of adopting for the last two years. Regulators have been especially frustrated with the lack of evidence that companies have been able to provide related to ensuring the study protocol is followed properly, that a risk management plan has been developed and followed and ultimately that patient safety is maintained above all else.
In general terms, OPRA uses data from the systems where trial data is typically stored to search for patterns and outliers in the data. The patterns are displayed to users in easy to read graphs which show how each site relates to the others within a set of data. Combinations of patterns yield a “signature” that provides insight into the behavior of the site attending to patients in a clinical trial. Identifying these signatures allows users of OPRA to assess the risk that the site poses to the patients and to the trial based on seemingly unrelated data already collected from the site.
Risk detection is only part of what the regulators require though and it’s the action and evidence process part where many companies are failing to meet regulatory expectations. In order to meet this expectation, OPRA allows users to record their observations (i.e., what they interpret, suspect, or need to investigate) at assessment points during the trial. Users can also track actions related to the observations so that specific tasks may be delegated and tracked in the system.
As the trial continues, additional data is collected and the sites are evaluated periodically. Hopefully the previous mitigating actions have had a positive effect. Here again, the regulators have had found a troubling lack of evidence that companies know the effect of the actions they took or if the quality management plan has been followed at all. Not only does OPRA keep track of the actions but it will show
the trend of the risk ratings over time along with the actions taken plotted on the same graph. This graph makes it readily apparent if the site is improving its score and demonstrates the management of risk for the trial.
Larger trials can easily run for three years or more. At some point, the regulators will want to see evidence of the risk assessments and mitigating actions that took place months and years ago. A company that cannot provide that level of insight may be cited for inadequate protection of patient safety. By using OPRA, companies can integrate the ongoing detection, action and management of site quality risk into the clinical trial process while providing the regulatory agencies the evidence of quality oversight they require and protecting the participating patients.
OPRA is easy to implement and use. TRI provides fully compliant and secure hosting with the SaaS offering and the pricing model is simple. Study setup is no more than a few days and OPRA requires nothing more than an internet browser for user access. There are no limits on the number or types of source systems; as long as the data is available in some electronic form, OPRA may be used to manage quality.
OPRA has been purposefully designed to closely align with the guidance set out for RBM by the industry’s top organization for cooperation among pharmaceutical companies, TransCelerate BioPharma. TransCelerate BioPharma Inc. is a non-profit organization focused on advancing innovation in research and development (R&D), identifying and solving common R&D challenges and further improving patient safety, with the goal of delivering more high quality medicines to patients. The cooperation and standardization that an organization like TransCelerate BioPharma brings to the industry is invaluable for the adoption of a change as significant as Risk-Based Monitoring. TRI has recently released an alignment paper which details exactly how OPRA meets the TransCelerate BioPharma guidance (http://tritrials.com/transcelerate-alignment/). The design direction TRI has taken with OPRA has also been influenced by the direction that the FDA, EMA and Metrics Champion Consortium (MCC) have taken with their Risk-Based Monitoring guidance. TRI is an active participant in the MCC and acts as an advisor to the MCC’s RBM working group.
Several top companies in the industry are piloting their RBM programs with OPRA at this time and the learnings from those pilots are already being used to direct the next evolutions of the platform. TRI’s CEO and founder, Duncan Hall stated, “we are already on the third evolution of the OPRA product and currently planning our fourth. The concept of evolution is about learning and adapting to one’s environment over time, and that is exactly what we are doing with the OPRA platform. The more trials we run, the more we learn, and the more quickly we are able to evolve OPRA to better meet the needs of the industry. We don’t believe in software releases, we believe in evolution.”
Through the experience gained in assisting the industry in RBM pilots, TRI has learned that the successful adoption of RBM is not just about implementing software but about changing business processes, roles and relationships. It is about the better use of clinical data earlier in clinical trial process. Ultimately, the adoption of RBM is a change program for any organization, and TRI prides itself in being the only company to take a holistic approach to RBM where we not only offer a RBM specific software, but also the operational, training and change management services required for any organization wishing to successfully implement a RBM program.