The role of digital health in clinical trials

Rose-Marie Pennisi – Pharmaceutical Manager

Digital tools and technologies are transforming the way clinical trials are being conducted and creating better engagement with more empowered trial participants and better collaboration between trial sites, clinicians, vendors and sponsors. Not only can these new innovative electronic tools and platforms improve site selection, patient recruitment, retention, monitoring and collection of trial data they can also reduce costs.

At this year’s virtual AusBiotech + Invest 2020 conference, a panel of leading industry experts discussed how the adoption of digital health technologies introduces a range of significant benefits and advances to clinical trial programs for the life science industry.

Fundamental changes are happening and with virtual trials now possible, making them much more patient-centric. Technology can now keep patients from dropping out of trials since they no longer need to keep going to the trial site.

COVID-19 has accelerated adoption of digital platforms and technologies and the use of simple technology such as Zoom, has enabled clinical trials to continue during the COVID-19 pandemic when in the past without this technology these trials would have been put on hold and patients would have to wait. Zoom has allowed sites to get support digitally, supporting both the clinical team and patients. Simple technology such as this opens up new opportunities.

Digital platforms are enabling online meetings for ethics committees, electronic submissions, electronic signatures and are having quite a profound impact on how trials are designed and the type of data that can be generated. Use of digital technologies enables KOLs and investigators opportunities to provide input into meetings they might otherwise not be able to attend and engage with all stakeholders. Better tools are available for trial planning, design and forecasting phases using activity-based costing for more accurate and efficient costing and digital whiteboards to facilitate brainstorming across geographic areas.

With greater technology comes a greater level of patient engagement and age should be no barrier with participation. For the technology to be effective patients need to be able to readily interact with their devices and engagement should be made easier and more fun. Patient-centric platforms including e-consent platforms can now include animations and videos and user manuals available in multiple languages having the potential for better patient engagement, troubleshooting and reduction in trial costs.

Innovative technologies are empowering patients to look for information, be engaged in their condition and be more proactive. They are also able to gather more accurate real-time data using digital biomarkers, novel digital endpoints and telehealth. We’ve come a long way since handwritten diaries.

Automatic data logging provides a better understanding of how a patient interacts with and uses their device and can collect many more data points. This has the potential to generate real-world evidence in a post-market situation.

Simply pushing technology won’t work and there are many considerations when adopting it. It needs to be seamless, embraced by and enjoyed by a range of users and suit the workflow. Other factors to consider are compliance and regulatory considerations around data security, cybersecurity, data privacy, sharing of data and audit trails. Also critical is compatibility and integration with other systems e.g. hospitals, medical records.

These innovative digital platforms and technologies have revolutionised the way we conduct clinical trials and opportunities and possibilities that a few years ago we couldn’t even imagine.

If you’re interested in incorporating digital tools and technologies into your clinical trials, contact My Medical Department to find out how we can help.

 

 

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