You can’t open LinkedIn without reading about Decentralized Clinical Trials. You would be led to believe that DCT is already ubiquitous and will be some sort of panacea for what ails the industry.
Companies like Science 37, Medable, Curebase and Thread have raised ~$350 million, $506 million, $57 million and $50 million respectively. With all of this money being thrown around, you would assume that a huge portion of trials are being run through these DCT platforms. Coming from a site network that runs phase 2-4 trials across just about every therapeutic area, this simply is not the case.
The overwhelming majority of trials we see are still relying on the same vendors, using the same strategies and same technology. On the ground, life is very much the same as it has been for years now. We are hearing some of these companies preach “site-centricity” but we have yet to see full scale execution in any meaningful way that involves sites. I have to believe that these companies are either disingenuous or simply failing in their mission.
Let’s look at the only easily accessible example of a large DCT company and their financials.
I’m no economist but something simply doesn’t add up. Is the industry not ready for DCT yet or have the promises of DCT simply been inflated? Is the current trend of very well funded tech platforms sustainable? At some point, it would seem that something has to give.
Even at the site level, I have attempted to implement some less all-encompassing DCT solutions and there seems to be a complete lack of interest on the part of sponsors. Whether it be a financial concern or the perception of increased risk, there seems to be very little excitement in attempting to reach a broader patient population and ease the burden of their participation.
Ultimately, who is driving the push for DCT? Sponsors don’t yet seem prepared to fully embrace it. DCT companies do not seem particularly profitable, even with millions in funding. Sites don’t fully even understand what DCT is.
Are we truly ready for DCT?
Some thoughts from someone who had been involved in these DCT companies when they were in their early stages. The problem really is multifaceted:
– The idea is there, but execution is challenging. Everybody seems to have an idea of what the ideal is and what DCT should accomplish, however, the actual execution of a full DCT study is extremely challenging from a logistics standpoint. We all know we need to bring the study to the patients home, but to find adequate resources (study personnel, shipping vendors, etc.) is very difficult. Ultimately, we go into it not wanting to offer 24/7 services, but end up having to do so. Conducting a full DCT study is so complex that it’s difficult to have a coordinator or nurse coordinator work on more than 1-2 studies at a time.
– Poor Study fit. You hit on a great point where not all sponsors are ready for DCT. And I totally understand that as some things are oversold and sound too good to be true. Ultimately, due to that apprehension, big sponsors give these DCT companies the hardest studies and the ones that are not great fits for DCT. It almost feels like “trial by fire.” But at the end of the day, these companies will try to make it work, and more often than not will only partially succeed or experience a “pyrrhic victory.”
– Vendors are not up to speed to meet demands of DCT. A full DCT study requires a lot of specialized vendors that all contribute to the completion of a successful visit. The main issue I’ve seen is that a lot of these vendors (i.e. shipping vendors, tech vendors) are not ready to handle the demands of a large-scale study. I’ve had shipments lost in transit, which ultimately causes visits to be postponed and cancelled…and leads to missed enrollment goals. If one vendor has an issue that day, it causes a host of issues and the visit cannot be completed. Talk about poor patient experience…
– Too much technology. I managed one study that had 6 different tech platforms and 6 different log-ins. Double data entry is bad enough, but when you have to ask an investigator to log into 6 platforms for 1 patient…they will want to quit immediately.
– Too many cooks in the kitchen. The best studies I’ve managed were ones where the sponsor worked directly with the DCT company as a partner. The ones that were almost doomed to fail were studies that involved a CRO acting as a middle person between the sponsor and the DCT site. The success of DCT companies are predicated on speed; however, oftentimes, we were unable to get clear information or all the resources from the CRO to meet expectations. To clarify, this is what I’ve experienced when we operated as a “sub-study” and the majority of the other sites were traditional brick and mortar.
– Overselling. There is definitely some overselling going on by these companies. Companies who conduct these studies inflate their capabilities and capacity and are directed to “figure it out after the ink dries.” Tech companies oversell how configurable their platform is, how user-friendly it is, and how quickly a consent / eCRFs can be built. I can see where the distrust is coming from. With VC funds potentially drying up the next two years, I can see these DCT companies trying to whatever it takes to get business.
Long story short…there are a lot of companies who have the “right idea” but all the efforts are disconnected. There is definitely a lot of overpromise going on, and the more that these promises fall short, the more distrust there’ll be in DCT.
Very well stated on so many points. I’m really interested in the ramifications to the industry if these big VC backed companies die. Will this dissuade sponsor adoption even more?
It is already well recognised by the DCT vendors that producing a successful solution that targets simply Decentralized Clinical Trials will result in at best small marginal complex business. The concept of DCT was sufficient to raise the VC/PE funds, but to the educated it is simply not viable in 95% of clinical trials.
Instead, the new target is a change to enhancing how traditional clinical trials are run. This is often referred to as Hybrid.
The trouble that all of the DCT companies face though today is that they simple do not have the technical or resource capacity to support the whole lifecycle of a clinical trial. It is for this reason that some supposed DCT implementations use 6 systems with 6 logins. As Patrick relates – a complete car crash for investigators for many many reasons.
Medable today works with Oracle for a reason – to give them access to the functional areas they cannot support – but this creates the mess of systems situation.
Regarding CROs and their miserable failures – I would concur to a degree. However, the root cause of the DCT failures through CROs tends to be the lack of technical and knowledge transfer maturity of the DCT vendors to adequately support (and Leverage) the skills and knowledge that the CROs bring.
The best DCT I was involved in was successful because the DCT company worked directly with the principle investigator to write the protocol and configure the platform. That of course is not scalable, but it is where it starts. Enterprise DCT comes well down the track.
The answer IMHO is not to abandon the good ideas of DCT but to implement them together as an end-to-end supported solution (Single Sign-On, connected workflow and single database) that supports each of the stakeholders. Dont think ‘EDC + ePRO +++’… think ‘Data Capture’.
The challenge here that Medable, Clinpal, S37, Thread, Curebase, Oracle and Clario are busy trying to solve to varying degrees of success.
For those interested, I blogged on the topic;
https://www.linkedin.com/pulse/edc-future-dct-part-1-doug-bain/ and https://www.linkedin.com/pulse/edc-future-dct-part-2-doug-bain/
I agree with Patrick as this becomes a barrier to adoption. Working in QA the issues I see are risk to data integrity as
these products often are immature in their development cycle and the vendors often lack functionality/process for basic things such as support for data changes, often leading to less then desired outcomes. Until these products mature the more traditional sponsors will stay on the sidelines with their studies.
That’s fair. Do you think that DCT will remain relegated to certain types of studies or that more traditional sponsors will eventually adopt it in a more widespread manner?