Why isn’t clinical research “digital” yet?

The problem of evaluating novel technologies in clinical research

There are a huge number of small innovator companies developing novel solutions for clinical research, but in many ways, clinical research looks similar to the way it did 30 or 40 years ago. One idea about why innovations such as Electronic Data Capture in clinical trials has taken 20 years to bring through to the “digital as usual” status is that there is currently no robust way for sponsor companies who run clinical trials to evaluate these technologies before they are deployed…

There is a huge amount of innovation within the clinical research space, with novel solutions such as software and medical devices evolving with a lifecycle of months in some areas. The clinical research lifecycle, meanwhile, evolves with a lifecycle of years (for a single study) or decades for best practice ways of working.

Currently the life science industry investigates these new software or hardware innovations directly within clinical trials, as exploratory endpoints. This exposes clinical trials, involving company assets with potential worth of billions of dollars, to unproven solutions with unknown risk and value profiles. The results of these explorations of novel technologies can often become available years after the investigation is started, while the innovation itself has advanced by multiple releases, or the innovator company has been acquired or ceases to exist, meaning that the readout on the technology is worthless. In summary, the life science industry is trying to rebuild their jet plane while they fly it.

If the life science industry had a way to evaluate these novel technology solutions before their inclusion in clinical trials and in a timely manner, it would have several benefits:

1. It would support the innovation ecosystem of life science companies, clinical trial hospital sites, innovator companies and support companies to learn more quickly about the appropriate use of these new tools by providing a rapid feedback loop for iteration and improvement.
2. It would enable companies to rapidly and effectively filter solutions that were “powerpoint-ware” (solutions with polished business development, but that were immature or had major flaws) from the solutions that were ready for deployment in clinical trials to add real value to clinical research.
3. It would provide real-world practical experience in the use of these solutions and their behaviour when performing outside the direct sphere of control of the innovator company. This practical experience would also reveal critical interactions between the life science company’s processes and the technology that would need to be addressed prior to a live deployment in a clinical trial.

The industry is still on a journey to deliver more value, and more rapidly to patients through the innovative therapies that are developed, however there are green shoots that the untapped potential of technology is starting to power this change...