A Digital innovation is the application of new technologies to offer solutions for existing business problems, issues. and practices. It is the application of digital tools offering an enhanced customer experience and solutions to any challenges.These are breakthrough innovations that help in creating world-class solutions. Digital innovations speak of the great change in every sphere of life. Digital innovations and digital develop are crucial to the success of any enterprise in the future.
Industries across are undergoing huge transformation due to digital technologies. The Pharmaceutical industry is no exception. Optimally designed and executed clinical trials are critical for success of the pharmaceutical industry as they consume the significant amount of their R & D budget. Digital technologies offer new possibilities to reimagine the clinical trials. They also bring about a paradigm shift in the way trials are designed, executed and analyzed. As new technologies emerge, there is a need for a systematic process to evaluate these technologies and determine how they will further enhance clinical trials process.
Digital transformation is happening in following areas –
Better Site Selection and Setup
Advanced data analytics can be used for site selection relying on factors such as past performance, suitability for trial and risk prediction. Sites across the world can be ranked based on their past performance and external information. This method includes digital site engagement. It incorporates a virtual tour of facilities, ranking and quality measurement. It also includes digital information exchange with the site and digital training & engagement of site personnel.
Improved Patient Recruitment and Engagement
Digital trials offer digital connects with patients based on screening of their health records. Instead of recruitment at a site, they are informed and recruited into trials digitally. As per the recent report, patients are recruited using the social media platform in nearly 11 % of trials. During trials, patients are engaged using adherence tools, compliance tools, visit reminders, patient query resolution, and their education.
Technology can be used to enhance the patient recruitment process by to geo-targeting around key study centers. It is possible to provide digital based infographics and videos, which are easy to share across social media platforms.
Improved Trial Monitoring
Advanced analytics and visualization tools allow for risk based supervision of trials. This includes risk-based monitoring, remote site monitoring and automated verification of information exchanged with sites. Innovative ideas include recording patient videos pre & post site visits and noting their experience and feedback.
Streamline Clinical Data Management
Digital clinical trials use cloud platform to gather and assimilate patient’s clinical data from different sources. The sources of data are trials using Electronic Data Capture (EDC) systems, wearable devices, telemedicine support and electronic health and medical records. This information is linked and stored in various repositories for further analysis and reporting.
Refine Trial Analysis and Reporting
Trials leverage advanced and predictive analytics to generate novel insights and evidence on risk-benefit assessment of drugs, patient subgroup performance and genetic basis of outcomes. The results can be combined with real-world data to evaluate the drug performance and its cost effectiveness in clinical trials. Intelligent reporting systems help in automatic generation of reports once analysis output is fed as input.
As technology continues to develop, there will be numerous opportunities to improve all aspects of clinical trials. While technology is important, it is pertinent that trials must focus on patient care and behavior change. The teams need to consider technology trends and carefully evaluate each new technology. Ultimately selecting the right technology would drive the success of trials for sponsors, investigators, and patients alike.