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The perspective on the (r)evolution in Clinical Trials that the Covid pandemic has influenced.
Interview with Ole Dammann Country Head Germany, CEO KFGN and Jack Evans, Executive Director Portfolio Management. Decentralized studies, new solutions, telemedicine are the newest keywords in trend.
During our fourth interview celebrating, Pratia’s International Clinical Trials month campaign, we wanted to analyze the (r)evolution in our daily business over the last year impacted by the Covid pandemic. We checked in with Ole and Jack to see how the way of work has changed with Sponsors, Patients, and Physicians. The impact of technology is key, its progress and implementation are here to stay. Decentralized studies are growing and will play a greater role in the upcoming years.
The Pandemic was a real black swan also for the Clinical Trials industry, from an initial freeze to finding new ways of operating – what is your perspective on this after 16 months?
Ole: The Pandemic with all its serious consequences and challenges has been also a big opportunity. It turned out to be a catalyst for new approaches accelerating the digitalization of clinical research. What seems to be something for the future has been either implemented such as tele-visits or will be implemented within the next trials – new consent processes.
Jack: The sheer speed at which the entire industry has operated, without compromising on quality is astounding. Everything from entire clinical development plans being executed in record time, to finding new ways to ensure the safeguarding of patients and their data has seemingly been completed overnight. It is important to understand that whilst we have seen what is possible, the mass resource and focus that has been provided by all involved is not sustainable as the norm, without significant reform.
How did it affect conducting local projects and global projects?
Jack: Now, we are seeing provisions being built into protocols in case site visits are no longer possible and need to be replaced with telemedicine. This appears to be preventative for the resurgence of case rates and social restrictions; however, it appears that this mechanism may be used in the future to better accommodate Patient/Physician availability. If this is the case, this is truly a benefit to all involved that has been birthed out of challenging circumstances.
Ole: In the first instance the Patient recruitment processes were put on hold. Getting more experienced with the COVID situation together with the industry new solutions, approaches were developed allowing safe conduction of clinical trials.
How did expectations of Sponsors or the way of cooperation change over the 16 pandemic months?
Ole: The COVID-19 situation has changed the way of collaboration with each other. Clinical research sites were included in the project much earlier than it used to be. This early involvement made projects possible that would have been failed in the past.
Jack:The Level of caution increased dramatically. Around March 2020, the majority of new studies were put on hold and I would go out on a limb and say with research sites, the level of cooperation from sponsors actually decreased. There was inherently a huge influx of new studies being prospected in COVID-19 as an indication, however despite huge amounts of work being put into the start-up and negotiation of these trials, many were canceled right before entering into a contract with sites. From a research site perspective, the management of capacity, the pipeline of work, competing studies and start-up workload without any reimbursement for these has had a major impact on how they view non-paid work and risk moving forward.
In what way technology in clinical trials can facilitate the communication between Sponsors, CROs, SMO, Patients and Doctors?
Jack: I think the next big thing is electronic source documentation, electronic medical records and truly remote monitoring. Time and cost savings are significant, but the barrier to entry is often high and preventative. Whether we like it or not, telemedicine is here to say, both in regular healthcare practice and clinical trials.
Ole: Right now, a paradigm shift is ongoing going beyond face-to-face communication. Whereas in some cases a personal exchange is inevitable tele-visits, as well as remote-monitoring, is lowering the burden for the single stakeholders. A more spontaneous form through chats or tele-visits will give the Patients an opportunity to share their concerns, information on their well-being more frequently thus increasing Patient safety.
What is the future of clinical trials post-Covid? What will stay with us?
Ole: The future of clinical trials will be a more decentralized way of conducting them, making the Patient to the center of data collection by wearables allowing new forms of health monitoring. Some of it we could already experience in COVID-19 trials.
Jack:All positives from my perspective:
Pressure on Competent Authorities and IEC/IRBs to expedite approvals and amendments will improve start up timelines now that we have seen what is possible.
Much more remote visit utilization, meetings and selections during setup, audit, and closure of studies.
Flexible study designs allowing for telemedicine options where appropriate
Increased clinical trial diversity and inclusion.
More Patients willing to take part in clinical research.
Do you think the industry is ready for digitalization or to what extent is it ready?
Jack: The industry is ready for it to be implemented, no doubt about it, but the infrastructure outside of the USA and Western countries is behind the curve. Even in many countries with advanced healthcare systems, paper records are still the go-to solution. For true digitization to occur, medical records, source, and study systems must all be at a stage where HCP's can access data in real-time, without the need to transcribe or scan information into digital formats. I believe we will see a pseudo-digital halfway point for a good many years before we achieve a status where it is uniformly beneficial across trials.
Ole: COVID-19 has been an accelerator for a lot of new digital approaches starting with remote monitoring and tele-visits. Digitalization and virtual trials are now omnipresent and will remain important for future projects. It will be great to see how it will change trial conduction making new therapies available for a broader group of Patients.
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