Our Take: DIA 2019 Takeaways

We’re back from DIA 2019 held in San Diego.While the conference consumed almost the entire convention center, the number of attendees walking the exhibit area was limited. This may have been a testament to the quality of the sessions as overall attendance was on par with previous years.

The preamble to the keynote as presented by DIA leadership demonstrates that the DIA has its finger on the pulse of the industry. It was announced that the industry is on the “verge of a data revolution.” This period in time is critical for clinical trial data integration and requires “global data sharing and collaboration,” something the DIA plans to facilitate.

In case you missed it, the DIA added a chief data officer in April and is now looking to launch a number of data-oriented best practice initiatives with names like “Thought Catalyst” and “Capability Builder.” The DIA and the membership-at-large see the importance and value of carefully curated data. This was our first glimpse to the DIA’s foray into providing additional services, and we will be listening to see how as a premier data processing and interoperating platform company, we can help.

The keynote was followed by a panel of experts dwelling on the sensitive topic of health data management ethics. We can’t say that the panel was able to solve any of these challenges, but the following comments caught our attention.

Who owns my health data?

As we increasingly rely on patients to provide more and more of their health data, the ownership of this data is still not clearly defined. Earlier in the year at HIMSS, we learned that an HHS rule drop will now mandate that all domestic EHR vendors must open up their databases of patient records; comply with HL7 FHIR as appropriate; and most importantly, “no data blocking” is allowed. A ruling clearly directed at the top three EHR vendors was to correct their perception on data ownership — just because other people’s data is in your container, you do not own it.

In clinical trials and research, we have been given the green light by the FDA as per the guidance issued last June on how to ensure compliance while using such data directly. However, the HHS mandate and the FDA guidance only address domestic sites using US based EHRs. This leaves clinical trials that are running globally in a quandary to address their data sources by geography. This will be a challenging problem requiring careful data governance and data integration management.

All international regulatory bodies are paying attention, and the prospects look promising, but in the meantime, expect a wide variety of data sources, formats and protocols before we can fully realize the dream of global data sharing. We at Adaptive Clinical believe that it is within reach.

Data dividend in research

Once we solve the interoperability problem as noted above, we get to the real and non-technical challenges of data sharing. Issues such as:

• Who can benefit from analysis of a patient’s data?
• Should they be compensated for using their data?

The ethics of making money on other people’s data is not new. In the scholarly publishing industry, science publishers and aggregators have been thriving on the backs of research authors who write to publish in peer-reviewed journals for credibility. Then those publishers and aggregators monetize that work for profit. The authors do not see any monetary benefit from their work and the publishers keep the profit. However, there is a big difference between our world (Healthcare and Pharma informatics) and theirs – in that, in publishing, the copyright ownership and reuse rights are very carefully defined and brokered in the submission process. Other than the consent form, we are lacking such a clearly defined instrument. Perhaps if patients copyrighted their health data, then we could follow a model similar to publishing where permissions are granted, bought and sold. We are still a long way away from that.

Liquidity of data

This comment from the panel of experts can be interpreted in multiple ways. On the surface, clinical trial data was always fluid, and as new information arrived from visits, it had to be managed so as to affect the resultant analytics tables. This results in the need for eClinical systems that can handle data both in motion as well as at rest. This may sound like a lot of technical jargon, but think back to when paper CRF forms were collected vs. now with direct data capture (eSource) where the fluidity of the data collected has increased. We also argue that the velocity at which data is being collected has increased significantly.

It is amazing that we still have an 8-day lag time for data collection from visit to EDC. If we layer data collected from wearables with literal streams of data — more appropriately the deluge of data — then we see that an 8-day lag is simply unacceptable. This “flow” of data from eClinical tool to another quickly requires an intelligent funnel to control the flow using a rule-based middleware.

Why Adaptive Clinical

As more and more vendors displayed Adaptive Clinical’s eClinical Bus in action at the DIA, the importance of and control of data based on smart rules has become apparent. Also, this year we saw a significant increase in point solutions ranging from AI and expert systems to predictive analytics tools, each consuming different data sources and generating more data points that now need to be managed. As organizations build out their platforms and integrate new sources of data, they are taking into consideration the cloud and its ability for varying customer needs. Gartner refers to ascendancy of the cloud and its critical importance today – so much so that many vendors and service providers face an “adapt or perish” situation.¹

Adaptive Clinical Systems offers a unique, simple, secure, validated, compliant, and cost-effective innovative solution for clinical data integration and interoperability. The cloud-based innovative Adaptive eClinical Bus® solution integrates clinical study data from multiple systems and platforms – EDC, eCOA, CTMS, Medical Imaging, IRT, analytical/data visualization systems and others – to ensure accurate and efficient transfer of clinical data for any study of any complexity while going well beyond simple and difficult to scale integration to full, real-time interoperability. We are referenced² in the Gartner report as a solution that connects and leverages internally-developed and proprietary systems in with commercially available tools (covering 90% of commercially available eClinical tools) and helps customers retain their competitive edge.

Adaptive Clinical’s eClinical Bus® can easily integrate third-party technologies into an interoperable, efficient, and accurate clinical trials system that streamlines processes and improves data reliability and offers the freedom to choose the best eClinical tools of any third-party or proprietary systems while enjoying all the benefits of a fully integrated system.

¹ Gartner Market Guide for Life Science eClinical Platform June 2019 page 3
² Gartner Market Guide for Life Sciences eClinical Platform June 2019 page 9