'On an average day when we're conducting clinical research, we're dealing with 60 different portals with different vendors... Simplifying it and getting sites paid for the work they actually do would definitely be a big win for everybody.'
For PCT TV at Partnerships in Clinical Trials Europe (Nov 2017) we caught up with Vivienne Van de Walle, Director and Research Physician at the independent research site PT&R. She gave some interesting insights on how the rapidly changing tech and partnering trends, and increasing study complexity are impacting clinical sites.
Read the key takeaways or watch the full exclusive interview below.
Which technologies do you see as having the biggest impact on clinical trials?
'I've been in the business for over 20 years so we've seen things progress from paper, to electronic EDC and eDiaries and iPads. It has been a challenge when these things are first implemented, but it has definitely now made work easier for us as a site. The data is much more quickly available both to data management and to pharma, ultimately hoping to shorten timelines so we can get the drugs to market faster and available to our patients.'
What new trends in partnering strategies are you seeing?
'We see that a lot of pharma companies now outsource their clinical operations business. We're not dealing directly so much with the Sponsor anymore, but more with CROs, or CRAs that are being hired by the Sponsor and they're acting as a CRA Sponsor, but are actually from a CRO. So there's this new structure.
I think it was actually last year (2016) that for the first time we broke the margin of over 50% was no longer working directly for the pharma company, but actually through CROs. It's a big shift.'
What are the biggest challenges facing the industry at the moment?
'One of the challenges is that everybody thinks they should be big or should be connected or be part of this big network, but I see a lot of these niche and smaller CROs, sites and companies that may be overwhelmed by the larger ones. I think it's very important that these little ones know that they do have a means of existence and they're very crucial for certain developments.
Larger networks, larger facilities cannot be that flexible, whilst the smaller ones can; they can be more tailor made, have short communication lines, can be quicker making change.'
If you could change one thing in clinical trials what would that be?
'As I'm from a site and one of the things that sites are always struggling with is the finances in the sense of payment terms, getting a good contract that actually covers all your costs and all the extra work. Way back when, you had a protocol flowchart and you could literally see on the flowchart what work you had to do and that's how you set up your budget. Nowadays, there's so much work around the protocol with all these vendors we're dealing with.
On an average day when we're conducting clinical research, we're dealing with 60 different portals with different vendors so there's a lot of work that comes with it with all the training. The funny thing is that they all say: "Oh, but our system is so intuitive", but we still need to do a three hour training for an intuitive system, which is a bit contradictory in my view.
So, simplifying it and getting sites paid for the work they actually do; if I could change that, it would definitely be a big win for everybody.'