The COVID-19 pandemic has dramatically shaken up clinical research around the globe. Trial professionals have had to make dramatic changes to their operations to remain afloat.
Outsourcing-Pharma (OSP) recently spoke with Iqvia’s head of process, technology and analytics Rajneesh Patil (RP) about the need for flexibility, and how intelligent use of remote monitoring, data management and other solutions can help sites survive.
OSP: It goes without saying that the pandemic has had an unprecedented impact on clinical trials. Do you think you could please share in a nutshell some of the immediate impacts and obstacles on clinical research, and how that laundry list of challenges has evolved in the months since?
RP: We need look at two primary areas of impact. How the trial participation is for subjects, and the ability to continue. With site access, there are several areas of impact, in terms of site staff availability. Clinical research has been fairly constrained and significantly impacted. Staff have had to come up with a lot of plans to maintain continuity. Areas include investigational supplies, and alternative technology.
With the reopening phases around the country, there has been an observable impact. It is clear some of the local government decisions to reopen the local economies have had an impact. We’re working to track a lot of the epidemiology curves, and predict recovery curves, epidemiology curve. We’re also keeping an eye on regulation. All of these are impacting the subjects’ ability to participate in trials.
Take the AsiaPac countries. There, we’re seeing trial participation numbers going up. The ability to access sites and monitor trials are becoming better. We’re taking a cue from that, factoring phase reopenings and recovery into our planning. We would be remiss if we didn’t.
OSP: What’s your impression of how the industry has reacted to these obstacles?
RP: In terms of industry response, there’s been resilience in terms of how to we’ve responded. Not just with patient participation but also site support, remote monitoring has been leveraged like it never has been before, and quick decisions have been made.
In addition, regulatory support has been there, enabling organizations to change basic operations and monitoring. There has been more technology and analytics—all in all, good, positive change, and we have been able to adopt and adapt.
OSP: Could you talk about how adoption of high-tech solutions has helped?
RP: Analytics as a capability has come through as a crucial enabler for managing risks across sites, enabling us to enact operational decisions on site access issues. Sites have been asking, Can we start doing remote monitoring?
Sites’ access to information and analytics has helped us make crucial decisions. Remote monitoring especially has helped give the ability to maintain subject safety.
A lot of protocol changes should be expected. This all enables us to be resilient, and data, support, and analytics enable us to make informed decisions.
With technology, there may be a big challenge at certain sights; there occasionally has been a general lack of adoption of technology, of new methodologies. We work with thousands of sites across the globe, and some of recent focus has been to bring those sites on the journey with us.
There is a maturity curve we would have to have to allow for these sites to take this journey. They are just starting to take on some of these technologies; they might even struggle with basic electronic data capture (EDC).
We have started site support services to help these sites adopt new technology. It is a challenge, with the investment going into it, assessing what kind of investment they might need, and quickly train the site staff.
There also is a great deal of new technology like connected devices, wearable sensors, patient-generated data, etc. If we start figuring in true implementation of such technologies, sites become a second choice.
Also, flexibility is important. The process may be difficult, with some slow learners needing more help. As an industry, we should put in more effort. COVID-19 has been a catalyst.
OSP: How might the clinical trial landscape be permanently changed in the post-COVID-19 world?
RP. There is a tactical aspect here, and over the last four months we’ve been seeing what response we as an industry have been settling on. The current response to the pandemic has been focused on maintaining continuity, and we’ve activated several hundred sitess.
Now we are shifting to what parts of these new operating models are here to stay, and what will be changed in the ecosystem. We have a fairly strong view that the landscape is going to shift significantly and permanently.
In terms of translation of patient and site experience and operating models, we seem to be moving more and more toward direct-to-patient methodologies—home-healthcare nurses, eConsent, electronic participation, artificial intelligence. The technology is out there.
Remote monitoring is becoming a big factor—staff can sit at a hub in Bulgaria, then manage sites in France and Italy. The traditional model is becoming passe.
