The COVID-19 pandemic, it likely goes without saying, has caused widespread disruption in the clinical research industry, including accelerated adoption of decentralized trial technology. However, it may be less apparent precisely how research leaders feel about virtual and hybrid research, or how the momentum in decentralized tech adoption might continue.
Oracle Health Sciences has checked in with more than 250 professionals from biopharmaceutical companies, CROs, and medical device companies involved in the operation and management of clinical trials, in order to gauge their views on decentralized trials. James Streeter (JS), global vice president of life sciences product strategy with Oracle Health Sciences, took a few moments to talk about the survey with Outsourcing-Pharma (OSP), and to share some of the most notable findings.
OSP: Could you please share some of the reasons you decided to undertake this survey?
JS: As we’ve watched the impact of the pandemic unfold, we’ve seen everyone – in all industries – having to screech to a halt and then adjust and figure out how to continue doing business and maintain forward momentum in a safe way. In the clinical trials space, all of a sudden, subjects couldn’t come to the sites for appointments anymore, and there was the challenge of how to keep studies going, while ensuring patient safety.
The FDA [US Food and Drug Administration] quickly issued guidance in March to help sponsors continue their studies and ensure patient safety, by allowing certain changes to the protocol and/or study conduct in light of the pandemic. In response, things like telemedicine and patient apps have been introduced, which are elements of decentralized clinical trials.
So, while we knew the industry was already moving in the direction of decentralized trials, we were curious about two specific things:
- if the pandemic was accelerating the adoption of decentralized clinical trial methods
- what the greatest challenges and opportunities the industry sees with moving to a decentralized model.
OSP: Please share your view of how attitudes toward and use of decentralized trial technology had evolved in the months/years before the pandemic landed on us.
JS: The introduction of patient-facing technology has made decentralized trials a real option for sponsors and CROs over the past couple years. However, moving in this direction requires change.
Trying to incorporate new world innovations into a traditional protocol design and modify operational practices has been a common challenge, as well as difficulties related to technology infrastructure, personnel, and even the classic ‘status quo’ attitude. So, while the industry has been interested in incorporating some of these decentralized methods into their approach for some time, many barriers have slowed this movement.
The COVID-19 pandemic forced the industry to take a hard look at these barriers and figure out how to break them down. We’ve seen great support from everyone – from sponsors and CROs to regulators, site staff and vendors – to figure out ways to keep studies going and keep the patient safe and engaged.
In addition, there has been support by the industry for keeping this forward momentum going, and not falling back into “the old ways” of conducting clinical trials when the pandemic is over.
OSP: Could you please share what you feel are some of the most notable or surprising findings in the survey?
JS: There were three notable areas:
- The pandemic has accelerated adoption of decentralized clinical trial methods. 76% of respondents indicated that the COVID-19 pandemic has accelerated their adoption of decentralized clinical trial methods.
- Data quality is the number one concern with remote data collection. Respondents indicated that data quality is a top challenge in adopting decentralized clinical trial methods and their primary concern when it comes to remote data collection.
- The industry is divided regarding the clarity of regulatory guidance. When asked if the current regulatory guidance surrounding decentralized trials and data collection was clear, 51% of respondents said “yes “ and 49% said “no.” Additionally, the vast majority of respondents (89%) reported that they were experiencing some difficulty complying with new guidance.
OSP: COVID-19 is helping fuel surging use and interest, but did the survey reveal anything about lingering reluctance in some circles?
JS: When asked about the key challenges associated with moving to decentralized clinical trials, survey respondents cited patient monitoring and engagement (59%) as the top challenge, followed by ensuring data reliability and quality (47%), and data collection (45%). These findings illustrate it’s not enough to choose a patient-facing technology – patient engagement and adoption, as well as the entire data flow needs to be considered.
Naturally, when you adopt decentralized trial methods, you also shift to decentralized patient data collection. We dug into this a bit with this research, also, and uncovered that the top three disadvantages of utilizing wearable and remote monitoring technology in clinical trials, according to respondents was data requiring a different approach to review, manage, and interpret (49%), expense (46%), and complicated regulatory considerations (42%). So, as is often the case, challenges with technology are often not technical.
OSP: You mention respondents showed some trepidation around data collection and quality, and regulatory guidance. Do you feel these concerns are legitimate?
JS: I don’t think this is at all surprising. In clinical trials, data is everything – at the end of the day, the regulators are looking at the clinical data to determine if the experimental therapy, drug or device is safe and effective, so it makes sense that data collection and quality, and regulatory guidance top of the list of concerns.
The data concerns also make sense when you consider the technology environment in which most sponsor and sites work. Over the past 20 years, many point solutions have been introduced to improve specific processes in clinical trials, such as data capture and drug randomization and supplies management, but these systems weren’t built to work together, so a lot of process redundancy and data quality issues have been introduced.
If you add in the complexity of data streaming in from remote devices and patient apps, you can understand the concern. To support the move to decentralized clinical trials, and the variety and volume of patient data that is going to come with it, you really need a single platform where the data can be collected, harmonized and analyzed quickly and efficiently; this is why we built Clinical One, which is the only truly unified platform that can do this.
OSP: What else would you like to tell us that we might not have touched upon above?
JS: While the COVID-19 pandemic has had significant negative impact on so many areas of our lives, it has also created opportunities for growth and positive change. I think the findings from this research reveal that the clinical trial community is ready to embrace innovation, new ways of conducting clinical trials, and better ways to engage the patients in clinical research like never before.
From a technology standpoint, we are excited to support this positive movement.
