Taking place over three days from October 4th to 6th, the eClinical Forum workshop enthralled guests with exceptional presentations, lively discussions, and valuable networking opportunities. With the chance to attend online or face-to-face, members listened in to around 15 workshop presentations on various topics, including decentralized clinical trials (DCTs), real-world evidence and digital health technologies, archiving and decommissioning, artificial intelligence (AI) and machine learning, hot topics in clinical research, and ‘in the news’ matters.
Among the list of speakers, several Viedocers had the chance to present their views, including Henrik Blomgbergsson, Co-founder and COO, on The challenges of backwards compatibility; Majd Mirza, CTO, on Use of blockchain to store audit trails; Alan Yeomans, Regulatory Affairs and Quality Assurance Manager on When does the Audit Trail start; and Lina Gaggi, Product Owner, on AI and Machine Learning. Everyone did a superb job presenting their case and holding discussions—well done, all!
Near the end of the Forum, our team asked a few of the experts in attendance to answer some of our questions concerning industry trends, forecasting and predictions, and other interesting hotly discussed topics in the clinical trials space. Here are some of the insights we gathered:
"I found the blockchain presentation by Viedoc—that was nice. But I mean, in general, you know, a lot of the presentations are trying to look into the future. And that’s very inspiring.” — Thomas Ellebæk, Clinical Data Scientist, Ferring Pharmaceuticals.
”DCTs are here, and they are being run in different models—and perhaps that's the key takeaway, that there is no one DCT model. There are many models and it's only going to become more and more than one instead of the exception. That said, there will always be therapeutic areas and indications that won't allow decentralized clinical trials, remote data acquisition it's called, but for those that can, yeah, that's going to be the future.” — Thomas Søndergaard, IT Quality Specialist, Novo Nordisk
“That there will be more opportunities for more and more outcome assessments to be captured anywhere, whether that’s at a patient’s home, near home, or outside.” — Bryan McDowell, Vice President of eCOA Science & Consulting, Clario Science
“I think definitely studies will start or are currently planning on using decentralized parts. — Ellen Wieting, Global Project Lead Data Manager, CSL Behring
“I'm hoping European Medicines Agency (EMA) is going to come with a final guidance and I hope they've listened to the comments from the industry on their draft guidance. And we're gonna just see more adoption of remote data acquisition. And EMA also pushing patient centricity. So I think you're going to see the next 12 months an even stronger push for patient centricity. But there's going to be ethical dilemmas about that. — Thomas Søndergaard, IT Quality Specialist, Novo Nordisk
“I think when we see the move or the evolution of using technology for technology’s sake, it’s actually using it where it applies the best benefits. We're seeing this coming through more and more as these congresses and events move forward, which is really good that we're starting to lead with science rather than lead with technology.” — Bryan McDowell, Vice President of eCOA Science & Consulting, Clario Science
“Yeah it’s the, or at least, parts of the decentralized tools, so the eConsent and home health and all these different types. So, I don’t think it’s going to be totally virtual, but at least parts of it will be used moving on in future trials.” — Ellen Wieting, Global Project Lead Data Manager, CSL Behring
“What excites me the most is the patient centricity. Because we're putting the patient at the center, you're probably going to have a better outcome. And a better outcome isn't necessarily that you have a successful phase 3AB in the market submission. A successful outcome can also be, after phase two, you need to stop this project. Fail faster. That can only happen, to me, by putting the patient in the center and getting real feedback more quickly. And that's also what the DCTs and remote data acquisition allow us—to get data more quickly so that we can fail faster and then move on to better potential Investigational New Drug Applications (INDs).” — Thomas Søndergaard, IT Quality Specialist, Novo Nordisk
“I like this possibility to talk about the DCTs—all the techniques and technology that we might use. It’s also the possibility to join other working groups and to hear what they’re doing. It’s very interesting. — Cecilie Moe, Special Advisor, Data Management, Oslo University Hospital
”That would be the smart techniques. I mean, the last, the one with the blood samples... Because I think, in general, the industry is more interested in finding devices and where we can do things smarter and more simple or easy for patients. One of the things I haven't heard after these talks is maybe, I think, there will be a reduced number of clinical visits, and that maybe could be reduced contact to clinicians, which could leave higher uncertainty for the patients. There are some risk factors that we haven't touched upon. I think it's very important with contact, so if we are to do things more decentralized, maybe not in our trials, but more broadly in the industry, I think it has to be more together—maybe remote consultations—in order to have a lot of human contact. Maybe it's just common knowledge, but I haven't heard anybody talk about this. — Thomas Ellebæk, Clinical Data Scientist, Ferring Pharmaceuticals.
At this point, we know that DCTs are here to stay, and bring with them many possibilites for promoting patient centricity. AI, too, may have a place in clinical trials—and goes hand in hand with DCTs and hybrid trials. In order to realize which industry trends may succeed and which will fizzle out is much like discerning when to put an end to a clinical trial—gathering real evidence and feedback, backed by data. And—most importantly—we learn from our peers. We thank you for participating in these discussions with us.
We’d also like to extend our thanks to the eClinical Forum for hosting the event at Viedoc HQ! If you’re interested in peer networking within the industry, take a look at the eClinical Forum.
Did you know that Viedoc is currently on tour? We’re attending several events, and you can peruse our calendar to see where we’re headed before autumn draws to a close.
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