On the verge of being born: Next generation clinical trials
28 June 2019
Tomasz Sablinski, Founder and CEO of Transparency Life Sciences raised the crunch question of the evening: Which industry is lagging behind the most in terms of digitization? Right, it is the healthcare industry! But who would have expected the usual lamentation of why this is the case; blaming regulatory constraints, scarce innovation culture, or unachievable technology barriers proved wrong. The appetite for change and finding new ways of doing things was too strong among Basel’s Healthcare innovators at the DayOne Expert Session on “Next Generation Digital Trials”.
The idea of the event was to present a holistic view of the current standing in the digitizing clinical trials. Stijn Rogiers from SAS and co-host of the evening, gave a good introduction to a changing landscape and explained why his company is prepared – having being around for decades as the “Rolls Royce” software provider in the fields of data science and analytics. Lars G. Hemkens from University Hospital Basel shared his experience on how integrating data, that has been collected on a routine basis, into clinical trials will make a difference. Tomasz Sablinski from Transparency Life Sciences showed ways to virtualize clinical trials or parts of them. Catherine Wu from Roche provided insight into how digital technologies may open up new possibilities for enhancing clinical trials, especially in the field of neurology. And last, but not least, Randy Ramin-Wright from Clinerion demonstrated how patient recruitment works in the digital age.
And these are my takeaways from the panel discussion which followed the presentations ((link to the presentations)):
1) Lowering the barriers
The digitization of clinical trials means efficiency gains and thus cost savings of 50 percent or more. This will free up resources to do more and better clinical research. And the ongoing virtualization of clinical trials will also lower the entry barrier for completely new and possibly disruptive players, based on indication and patient-driven data ecosystems.
2) Rediscovering new disease areas
Investments flow to low-hanging fruits first. The introduction of digital (in combination with traditional) biomarkers make formerly higher-hanging targets more achievable. The interest in finding novel treatments for neglected and rare diseases will thus be further accelerated. But of all the fields, mental health will gain ground due to the much more solid measurements of outcomes based on real world evidence data – complementing or replacing questionnaires.
3) More data means more complexity
Clinical trials follow the philosophy of reductionism, so, narrowing the focus to the endpoints which are deemed relevant to prove the outcome. By integrating more data captured by the patients or originating from routinely collected data, collections, the spectrum, the granularity and the continuity of a clinical trial can be noticeably augmented. But this also reintroduces complexity. Maintaining a clear view in all of this “noise” will be a big challenge and necessitate collaborative efforts.
A huge thanks to all of the speakers for contributing and sharing insights!
Data Analytics Perspective: Stijn Rogiers, SAS
Clinician Perspective: Lars G. Hemkens, University Hospital Basel
Startup Perspective: Tomasz Sablinski, Founder, Transparency Life Sciences
Implementation Perspective: Catherine Wu, Roche
Patient Recruitment Perspective: Randy Ramin-Wright, Clinerion