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This industry won't be going back to “the old way.” Oracle GM and SVP, Henry McNamara, makes predictions for sponsors and CROs in 2021.
The lockdowns of the COVID-19 pandemic had a major impact on clinical trials in 2020, leading to rapid adoption of telemedicine and decentralized trial methods. This will continue in 2021—the industry is not going back to “the old way.” Therefore, sponsors and CROs need to set themselves up to operate successfully in this new model.
Companies will increasingly turn to mHealth devices to gather data from patients remotely. This increased volume and variety of data coming from these devices will require unified technology platforms capable of collecting, managing, and analyzing it.
The pace at which study teams have been working through COVID-19 trials is not sustainable. Despite interest in maintaining this “pandemic speed” of trials, staff simply cannot continue working 20-hour days, seven days a week, technology to streamline repetitive processes, automate trial design, and otherwise reduces the routine workload on professionals.
Artificial Intelligence (AI) pilot projects among sponsors and CROs in safety case intake and site selection have proven that AI is more effective and accurate than humans in these scenarios. These early successes mean that we’ll soon see AI go mainstream, with great expansion into these applications, as well as many more. As more companies lean into decentralized trials, and as the pace of trials and the amount of data that needs to be analyzed continues to increase, AI will emerge as the only way to process this data efficiently.
Regulatory guidance around decentralized clinical trials is widely seen as unclear. Moving forward, as situations require and technology enables a continued shift to decentralized trial methods, regulators will respond and accommodate the adoption of these methods
Henry McNamara is the GM and SVP of Oracle Health Sciences