Three focus areas to accelerate breakthrough drugs to market
The number of clinical trials taking place each year continues to rise. In fact, in 2018, the FDA approved a record-breaking 59 drugs[i]. Volumes are increasing, in part, due to the shift towards precision medicine. And the impact these drugs are having on patient lives is significant. For example, it was recently announced that NHS patients with lymphoma are being given a pioneering treatment that genetically reprograms their immune system to fight cancer.[ii]
The pace of R&D innovation is getting treatments to patients faster, but it is also putting pressure on clinical operations teams. There are now more complexities in running trials and organizations have a greater need for improved trial efficiency.
Key focus areas to transform clinical operations should include managing study-start-up processes, improving information exchange in trials, and unifying clinical applications.
1) Managing study start-up processes
The industry has made tremendous progress in adopting advanced clinical applications, but there are opportunities to improve. In study start-up, for example, the Veeva 2019 Unified Clinical Operations Survey revealed that 100% of clinical operations professionals experience significant challenges, likely due to the continued use of spreadsheets to manage study start-up processes. Sponsors and contract research organizations (CROs) are increasingly adopting purpose-built study start-up applications to speed cycle times.
2) Improving information exchange
Another area ripe for change is improving information exchange in clinical trials. Sponsors are turning to CROs to complete trial activities faster and manage costs more effectively. However, adding partners to the mix involves working across different systems and processes. And there is no standard or effective way to share trial data and documents across sponsors, CROs, and sites. In fact, clinical operations professionals use on average three methods to share trial data and documents. Improving collaboration (66%) is among the top drivers to improving information exchange.[iii]
3) Unifying clinical systems
Unified trials streamline stakeholder communication and collaboration. The exchange of trial information is simplified (and where possible, automated), and study progress is made visible to all parties in real-time, ensuring stakeholder alignment and improved trial performance. Nearly all sponsors and CROs (99%) agree they need to unify clinical applications for greater visibility (70%), faster study execution (63%), and easier collaboration (61%)[iv].
Companies are seeing success from unifying their clinical environments. Idorsia, for example, is a fast-growing biopharmaceutical start-up focused on research and early-stage clinical development. With a strong pipeline of innovative new therapies, it needed cutting-edge cloud technology that could scale as it grew. It implemented unified applications for clinical, regulatory, and quality, and it has benefited from greater efficiency and compliance throughout development.
Addressing these three areas will enable organizations to improve trial efficiency, visibility, and quality. This will enable the industry to rethink how studies are conducted – and adopt new and more effective business models that drive trial performance, simplify data sharing, and encourage collaboration – accelerating the delivery of breakthrough drugs to market.
Rik van Mol
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