Dave Iberson-Hurst reflects on the TransCelerate Hackathon, the impact of the current pandemic and Swiss Chocolate.
TransCelerate Digital Data Flow Initiative
I cannot remember when it was, but I think it was around January that I read a document published by TransCelerate about the Digital Data Flow (DDF) initiative. The words ‘social distancing’ had yet to be placed next to each other in a sentence and the world was yet to really know much about what was to become known as coronavirus or COVID-19.
One paragraph …
The document, to me, was a little un-exciting. It was a rather technical document and we all know that technical documents are always a tough read and I wasn’t quite getting it; it was probably just me being tired. Then I read one paragraph. It was one of many in 13 pages or so but that one paragraph was all I needed. It sparked a thought or two and it convinced me about the value of the initiative.
“For example, using the TA Library for Asthma, a study in severe asthma could have as its Primary Objective “To evaluate the effect of drug x in participants with severe asthma.” The primary endpoints linked to this objective are limited to “absolute change in percent of predicted FEV1 from baseline to [Week X]” OR “increase [magnitude of change] in FEV1 from baseline to [Week X].” This also implies that the FEV1 biomedical concept will require spirometry assessments to be scheduled at baseline (CDM: primary timepoint) and week X visits (CDM: secondary timepoint), and that FEV1 measurements will need to be captured in the study database, either by EDC or via data transfer. Further, options for Secondary Objectives include FVC or FEV1/FVC ratio (spirometry), reduction in symptoms (questionnaire data) or fewer Clinical Exacerbations (medical history or diary data) or reduction in the use of rescue medication (diary, dosing device or medication count data). As each objective is chosen, the appropriate choice of linked assessments and measures would also be assembled in the tool using the latest available standards for that assessment.”
The World Changed
Quickly fast forward a couple of months, a webinar or two from Transcelerate and the start of March 2020. Coronavirus is now with us. Italy is in lock down and face-to-face events are being cancelled. The CDISC Italian User Group has been cancelled and we had taken the decision that it was unwise to send people to the US for the PhUSE Connect which was cancelled a few days later. It was a Thursday morning and I attended a partner meeting. We decided it was time to ask people to work from home; the risks were hard to assess and why put our staff at risk. Our decision was quickly overtaken. A few hours later the Danish government announced a series of measures to prevent the spread of the virus in Denmark. On Friday 13th March, we made the last arrangements for people to work at home. Monitors, keyboards and the like were carried home, being Copenhagen, some on bike.
The TransCelerate Hackathon was not organised like a connectathon. I have participated in quite a few connecathons, where you try and connect systems and share information. With the Hackathon, we were a given a vision and a specification. We were challenged to deliver something that matched; basically, hack something together. We had planned to start work on the exercise the Monday after we started working from home. The work schedule had been cleared, the whiteboards cleaned, pizza orders contemplated. But the best laid plans of mice and men were now in disarray. On that Monday morning the team were all at home. Social distancing was a reality.
Taking Care of the Team
Foremost in my thoughts were the team. Working from home is not easy for some, especially when you put social restrictions on top. It’s tough asking people not to leave home other than to exercise or buy food. Some find it hard not having the face-to-face interaction that an office environment offers and people react in different ways.
A New Routine
We held a meeting every morning – we still do as we are still working from home – discussed what had been done and then what we needed to do next. We also chatted about COVID-19 news and updates from the government to make sure everyone knew what was going on. We have a multi-national team, drawn from five countries and not all are native Danish speakers. We wanted to ensure the team knew what was going on and had the latest information and stayed safe.
Socially Distanced but Together
We made a quick decision to start using Microsoft Teams on the first day of social distancing. Now, as my colleagues will tell you, I am not a Microsoft fan, but Teams has worked well. It has allowed us to get close to the interaction of the office. Now there are many who will support home working for all for ever. Others will argue for an office environment. Neither is a panacea. A combination works well. I would happily not see another soul for a week, others need interaction with people, that coffee and chat in the kitchen moment. I value the discussion over a whiteboard. Nothing replaces the overheard conversation that pre-empts some impending disaster. But, everything taken into account, we have managed well and, in the first phase, I have rarely known a team to be so productive.
TransCelerate Technical Work
The Transcelerate technical work was interesting and offered us a chance to achieve something notable. We didn’t quite manage to build everything we wanted – we got very close – but our technical solution took a massive leap forward as a result of participating in the Hackathon. More importantly, our understanding of the problem space has increased considerably. With development I like to aim for more rather than less because that way I feel you tend to achieve more. Yes, you often fail to achieve everything you planned but it pushes you. I always look to the words of President Kennedy spoken in 1962 where he said:
“We choose to go to the Moon in this decade and do the other things, not because they are easy, but because they are hard.”
There is a lot to be said for stretching for that goal that seems out of reach.
Building the Solution
We decided to take our 2nd Generation MDR and build the hackathon functionality into it, linking it to the functionality in the existing Study Workbench (SWB). This provided a continuum from Protocol design through to the creation of:
- epochs and arms,
- study objectives and the associated endpoints
- to the creation of a study timeline
The study timeline contains all the desired observations, down to single observations, from which the study Schedule of Assessments (SoA) is then auto generated. From this SoA, we can then, in real time, tell you which domains are being used, which variables, generate the aCRF and the define.xml for the study.
The work was enjoyable. It involved a few late nights and we had to continue with our production work.
As TransCelerate had extended the delivery date due to COVID-19 situation, we returned to the ‘hack’. So on Monday 20th April, we submitted our package of slides, videos, and words and sat back. It was nice to complete it, disappointing we didn’t quite fill all the holes we wanted to but an enjoyable exercise. Late nights were worked but social-distancing sort of killed the need for team pizza.
Learn, Iterate, Move Forward
The team produced an incredible amount during the time we allocated to the hackathon. We learnt a great deal and we have set ourselves up for the next big production features. We can see things we have never envisaged, possibilities that we thought were out of reach are now within our grasp. We managed to easily integrate the aims of the DDF project into our existing graph and build a better model of the world we operate in. It isn’t perfect, it never will be, but we iterate forward making it better each time.
Still Socially Distanced
With the hackathon completed, social distancing is still with us in Denmark, although you can now get a haircut, a massage or a tattoo! We hope that we may start working back in the office in mid-May, but it won’t be all of us at the same time, restrictions will still apply. We continue to operate using Teams but it would be nice to see each other even if only for 15 minutes.
And the Toblerone? Every so often we have a beer or wine across a video link. As part of looking after the team a small goodie bag was delivered containing drinks and snacks to have during our meetings. Many a mini-Toblerone may have been harmed/consumed during the making of this Hackathon.
Want to know more? Look out for our forthcoming webinars and if you would like a demo of our solutions, get in touch.