DIA Europe Conference 2019
The annual European DIA conference took place in Vienna this year. After the opening speech (which involved a flash mob of attendees doing a waltz across the main conference hall!), the conference kicked off with the first key note session of the week. Dave de Bronkart, aka ‘ePatient Dave’ was given 24 weeks to live upon a diagnosis of cancer. Dave described how he became one of the first ‘ePatients’, a term used for patients who use the internet to treat, and sometimes cure, their own conditions.
Things have changed since the times where medical professionals implored their patients not to use the internet to self-diagnose and treat. Dave presented a strong case for the need to engage patients and to open the internet as a tool to be used for patient empowerment. This shift will impact the industry greatly. When we set up clinical trials, we need to consider that patients are now a lot closer to their data than they used to be. When designing data capture systems and devices, we now need to ensure these will be user-friendly and will encourage patient engagement more than ever before. The FDA has even suggested that the degree of subject involvement in a study may be used as a quality indicator.
Patient engagement was a strong theme throughout the conference. The need to train and prepare subjects for trial participation was highlighted. A common complaint from subjects is that they have participated in a trial and then never heard back from the pharma company involved. The industry is trying to change this by seeking to share information in a transparent way and increase the level of data collection over and above regulatory requirements.
Another hot topic was artificial intelligence (AI), the ‘fourth industrial revolution’. The challenge of bridging the pharmaceutical and IT industries was discussed. A specific skill set is needed to produce algorithms which can assist in clinical decision-making and the industry regulators will also need to be able to understand and validate these technologies. It will also be a challenge to prepare data ahead of implementing AI, highlighting the need for standardised data collection. At PHASTAR, we are excited to be driving this forward through our data science group, as well as from a data management perspective, by implementing CDASH standards on trials wherever possible.
The second key note session, delivered by Hans Lehrach, focussed on the topic of “virtual patients”. Genomic modelling has the potential to shorten the drug development process - by modelling specific body systems, virtual patients can be used to simulate clinical trials, leading to reduced timelines in releasing new treatments.
Jonathan Palmer from Oracle delivered another talk focussing on the implications of digitalisation in the industry. Wearable technologies are being used in clinical trials, but there is still a sense that some regulators are yet to be convinced by the integrity of the data. These technologies can also produce a staggering volume of data, which can be an issue for clinicians who are already receiving data in high volumes. There is a need to streamline technologies to release quality data and extract the relevant information that can be utilised in research.
Another interesting topic covered at the conference was whether randomised controlled trials are still the gold standard in research, or whether they will be replaced by more innovative designs such as the umbrella design, which allows more flexibility by running multiple treatment arms in parallel and assessing whether to continue or replace certain arms following interim analysis. The need for regulatory understanding of these designs was also discussed, with emphasis placed on the need to involve regulators from the beginning of trial design and to get regulatory input at an early stage.