With the arrival of Covid-19, the move to the increasingly popular decentralised clinical trial (DCT) model has been accelerated. The pandemic has lit a fire under the healthcare industry’s uptake of technological innovation and there seems to be no turning back.
Medidata has been in this space for decades and so far has used its decentralising technologies at more than 44,000 clinical sites, including nearly 600,000 patients.
Now the firm has become the first to offer a completely unified end-to-end DCT solution customisable for any level of decentralisation, the Medidata DCT Program.
Clinical Trials Arena sat down with Medidata’s senior vice president of clinical operations Lisa Moneymaker to discuss being the first company to launch such a solution, how the new platform is grounded in patient centricity and how it helps sponsors and contract research organisations (CROs) mitigate risk.
Kezia Parkins: Can you tell us about Medidata’s DCT program?
Lisa Moneymaker: At Medidata, we have been preparing ourselves for over 20 years to support the industry for what we have seen coming as the future of virtual trials and have steadily been layering technologies onto that. A big part of that has been looking at how we can change the patient journey and be ready to support patients wherever they’re geographically located, to make sure that we’ve got the right care available to extend to more patients.
Ultimately, this virtualisation really changes the shape of the data and the monitoring patterns associated with traditional clinical data. As Medidata continued its progression in that patient-centric and DCT space, we were simultaneously preparing for what would we do with data from apps, devices and wearables, which comes directly from the patient with no physical copy. Additionally, we looked at how we support sponsors and CROs to be able to monitor that data and change the patterns of how they would then interact and ensure quality and patient safety.
That’s where the DCT program came from. In order to do this right and be sure that we’re supporting patients and trial safety and efficacy, it had to be an end-to-end approach.
Companies will be moving towards whatever version of decentralisation is appropriate for their study, which may need more or less decentralisation depending on the therapeutic area or geographic location they are working in.
By stitching these components together, both at the data layer and at the workflow level, we can allow companies to tune that to exactly what is right for each particular study. That’s where the Medidata ‘Trial Dial‘ comes in. It means it’s not binary, it’s not just decentralised or centralised – it’s whatever is right for the company, their strategy, their investigators, sites and patients.
It allows companies to land on just the right combination of patient-centric and site-supported technologies and monitoring strategies to be able to support that end-to-end. Because of the work that we’ve been doing over the last 20 years, we were uniquely suited to be able to bring the full suite of capabilities to that, to really allow companies to apply their vision of excellence to this and take advantage of all the different pieces that we bring to bear.
KP: There is no other technology provider that supports this hybrid type of study design on a single data platform at both the patient level and the site level. How were you the first? What challenges do you think others face in trying to do the same?
LM: When you look how to make that data flow end-to-end, if you’re bringing a lot of those different point solutions together, then we’re talking about integrations and opportunities for dropped workflows and maybe a less holistic view of the data. Fundamentally, the unification of all of that is quite hard.
This has been the evolution of Medidata, as the first to provide technology for that data acquisition layer. For us, it’s really been that maturation.
With Medidata Rave, we’ve been the trusted partner for companies for over 20 years and we just continued to build on how we can bring them more insights.
Honestly, there’s no shortcut to those years of experience. I think that that’s why we were able to be first and genuinely, I think it’s going to be that way for a while.
It’s taken us a long time to make that full wraparound and to be able to earn the trust and the collaboration of sponsors, CROs and sites. We have over a million trained users on the Medidata ecosystem and are the most trusted partner for sites in terms of performing trials and putting data in right. You just can’t skip over any of those steps, so our extension into being able to support that end-to-end was very natural for us but could be a challenge for anyone who needs to continue to build all the way around the wheel of capabilities.
A video demo of Medidata’s new DCT Program.
KP: What are the benefits for patients, sites and sponsors?
LM: For some patient populations, coming to the site regularly can be a huge burden and not viable, so being able to treat them and complete evaluations off-site is critical. Whether a trial is physical or virtual, it’s really about providing the opportunity for extension into patient populations that sites and sponsors may not have been able to have a physical presence in before.
When we drill into particular technologies, like the ability to have e-consent, we can demonstrate really amazing control over how we want that information delivered to the patient. We’re not just giving them huge paper forms that they can’t digest – we’re able to work with sponsors to come up with the right methods of delivery for better patient comprehension and better understanding of the trial. That way, we get better compliance throughout and fewer dropouts.
With myMedidata Live, we can extend into video visits if a patient can’t make it to site. The scheduling of those visits is wrapped into that same data ecosystem as part of the same DCT platform. We can then extend it to a patient diary so patients can record how they are feeling and any patient-reported outcomes (PROs). We can then tie PROs to an investigator-reported outcome.
When there is a discrepancy in the patient-reported scores versus the physician reported scores that can be a risk to the trial, so potentially an intervention could be needed. A clinician on the sponsor side can see any patient-reported data that’s discrepant from investigator-reported data in really powerful plots and anomaly detection. That empowers the sponsors and CROs to take a much more proactive approach with the sites.
KP: How will the program help mitigate risk and allow CROs to easily adopt risk-based approaches to study execution?
LM: We have seen incredibly slow adoption of risk-based monitoring at most companies over the years, with people taking one step towards a risk-based approach and then a step back. We weren’t doing it holistically.
One of the key reasons why is that technology vendors weren’t really there to support the companies in how to do it well. If you’re taking a piecemeal approach to a risk-based strategy, it is inherently doomed to either not be effective or be extremely expensive. We think of risk-based quality management like an equalizer of an old school stereo – there are lots of different dials you can turn up and down.
These include things like risk assessment, source data verification and review, onsite monitoring, remote monitoring, centralised monitoring and strategies to bring the data together. You can really play with those strategies, but if you’re not doing them in concert it’s a hard switch to go from one type of monitoring to another so all you can do is add more. This then turns the cost factor up for CROs.
From our perspective with this holistic approach, we can look over the study design and ask; what are the areas that might be the riskiest? What are my endpoints? What are the digital pieces of information I need to collect and the risks associated with them? Then you can explore mitigations to stop those from becoming a risk and trace them.
That sort of integrated approach lets you get really refined in the way that you monitor and react to the data. That becomes really important in DCTs because we end up with a different series of risks that can come from digital endpoints, collecting patient data and variants in patient and site scores.
Appropriate risk controls at the beginning really can be the heart of how you have a great decentralised trial because you’re showing incredible control of what otherwise can be quite an amorphous trial design.
KP: How has patient involvement helped shaped Medidata’s DCT program?
LM: We have patients participating in trials who come in and help us design these programs and provide insights and feedback. Within our Patient Cloud group run by Medidata’s Anthony Costello, we have a tremendous number of former and current patient advocates who are actually employed by Medidata.
We have a wide variety of patient-centred data and Anthony and his group bring patients into the design of the various tools that will be patient-facing. That applies to e-consent, electronic clinical outcome assessment (eCOA), virtual visits, patient diaries and to sensors and wearables.
We now have an entire web of pre-validated devices able to be deployed on a study and ready to work and be monitored within the Medidata data ecosystem. All those patient-centric tools allow us to empower and engage with the patient in all the different stages of the trials. From the sponsor perspective, that means really understanding that level of the patient burden and patient impact when they’re designing the trial.
Patient Registries are also a part of our DCT program and allow us to meet the patients where they are, increasing engagement and awareness of clinical trials and how folks can get involved in them.
We have unified the whole patient experience. Within the myMedidata ecosystem, that Patient Cloud becomes the single point of entry that sponsors then can connect to them through. That means one experience for them that follows the life of their journey across all clinical trials they may be involved in.
We have long term follow up of the patient in their journey and no matter how many trials the patient is a part of they have a single point of access, one login all housed under one platform.
KP: How has Covid-19 pandemic boosted the uptake of technological innovation in the industry?
LM: There’s simply no end to the change and inspiration that we’ve seen in the last year. Medidata has been building towards a fully end-to-end DCT program for a long time. This isn’t something we woke up in mid-2020 and decided to do.
Our industry as a whole can be very slow to innovate and we’re very risk-averse, as we should be. That has a tendency to trickle into the technology space, and our willingness to innovate and to change. What we saw with the pandemic was an innovative fire that was lit under everyone. As an industry, we had no option but to innovate and change overnight. Not being able to interact with each other in the same way was a huge part of that.
Companies who were already employing some virtual strategies or who already had access to our myMedidata tools around patient engagement and live video visits fared better fundamentally than companies who had to quickly spin that up.
Across the board, we saw that this sparked willingness to go all-in on DCTs after perhaps spending a long time thinking about making the move. I think it just propelled the industry to where it needs to be.