A Fresh Take on DIA

This year’s DIA Annual Meeting was an experience of firsts: my first year attending as a member of the TransPerfect Life Sciences team and my first year spending the majority of my time on the exhibit floor. In previous years, 90% of my time was spent in the sessions offered throughout the conference and I would conclude my attendance with a blog post summarizing my takeaways. This year, I spent my time talking to attendees and learning what was on their mind. This role reversal provided me with a fresh perspective of clinical professionals in search of solutions to their business challenges.

Following the Plenary session, I made my way down to the TransPerfect Life Sciences booth in the exhibit hall. It took no time at all before I was deep in conversation with sponsors and attendees. In fact, every time I turned around I was introduced to a new visitor. There were plenty of familiar faces as well. Much to my amusement, many had a visible moment of befuddlement as they unexpectedly bumped into me in the TransPerfect booth for the first time. By 1 PM I felt like I had already spoken to the entire DIA attendee and sponsor list.

The interests of both visitors, while all specific to clinical trials, were also fairly broad in focus. One minute I was speaking to a sponsor about labeling creation and the regulations therein; the next moment I was deeply engaged in a conversation regarding eCOA and the recent publications proving electronic equivalence (the eCOA holy grail, as it were). However, after three days of non-stop dialog, some very clear patterns emerged.

Here is what seemed to most be on the mind of study managers:

• Clinical Services (Kits)
• eCOA
• E-Clinical (eTMF)
• Patient Recruitment
• EDC
• IRT

Clinical Services (CS)

Labeling and the creation of labels in a post-Brexit world is clearly on the minds of study personnel. One big question is: what will happen to the template with the UK out of the EMA?

Script creep continues to be a problem for CS personnel as it is frustrating and can have a significant cost implication. Most study personnel understand that it is inevitable. What can be done to mitigate that risk? I offered some strategies during these chats and am looking forward to the follow-up dialog to explore in more detail.

eCOA (Electronic Clinical Outcome Assessments)

I don’t know if it is the recent publications proving electronic equivalence to paper by EORTC or Byrom et al or something in the water, but suddenly a plethora of eCOA vendors are popping up in the market. What used to be the domain of two or three vendors is now occupied by well over 15 vendors. We received a massive amount of eCOA interest at our booth. Some attendees were very advanced in terms of deploying instruments on devices, others were nascent wondering how to go about device testing. It was a pleasure to experience the trust attendees displayed in TransPerfect’s eCOA expertise. As a fairly new addition to the organization, this made it all the more possible to have fruitful conversations.

E-Clinical

Many sponsors came to our both with eTMF curiosity or frustrations with their current setup. Those that were looking to adopt eTMF technology for the first time were looking to understand what the Trial Interactive eTMF had to offer in comparison to other systems. They also sought guidance on the right approach to e-clinical technology for their operations. Those that already deployed enterprise e-clinical technologies were simply looking to find products that were a better fit for their operations and specific digital infrastructure.

It was clear that many would benefit from reduced complexity, in order to more practically a) achieve their objectives and b) save study costs. I was on site with the Trial Interactive innovation team, who provided demos of some of the applications within the Trial Interactive platform, including TI eTMF. From there, sponsors were able to learn firsthand about an alternative approach to their e-clinical strategy, including the benefits of improving the lives of CRAs through a mobile experience.

Patient Recruitment

The debate between patient networks vs. advocacy groups or traditional tactics vs. owned site networks for patient recruitment rages on. Some patient recruitment (PR) companies believe access to private site networks will reduce the burden on subjects and speed enrollment into a study. Others are investing in a solution similar to mHealth—speaking directly with the patients to increase both enrollment and retention. It would appear that both strategies have compelling value propositions. Regardless, TransPerfect stands ready to assist in terms of globalizing the materials used.

EDC (Electronic Data Capture)

While a mature market, there were two newcomers that visited the booth. Both had differentiating elements from that of the incumbent EDC providers and it was exciting to see how innovative some solutions are. Serverless solutions and SAS seem to be the watchword at the moment. For more information, read our previous post on some of the implications of serverless technology for clinical.

IRT (Interactive Response Technology)

Based on booth conversations, the challenge of dealing with complex drug regimens in a study has evolved to focus on speedy deployment. Flexible builds and fast turnarounds seem to be key. User acceptance (UA) can easily be reduced by reusing as many assets as possible to build a working IRT system.

The other theme that came up with a number of providers was that of chain of custody. The concept of full accountability of kits to sites, return, damaged, etc. all in a validated system. I was surprised as to how much development still has to be accomplished on the back end to achieve full compliance.

DIA 2018 was a completely new experience for me. With my routine flipped on its head, I was met with a flood of organic conversations that tested my knowledge across many topics that are critical to clinical professionals. To say the least, it was invigorating. It also was a clear indication that clinical teams need vendors to listen attentively to their emerging needs. As more innovation via technology and service solutions seek to close gaps and create efficiencies, other considerations emerge, while old considerations often are still in need of ongoing attention to completely address the nuances. Next year, I may just dedicate my time to the floor again…but I will make sure to pack a lunch!