During our recent webinar on “3 Major Disruptions to Clinical Trials” with Jon Shephard and Chris Baker we received many audience questions around the impact of AI and Blockchain in Clinical Trials. So we asked a curated panel of leading experts on ArbolusChannels for their perspective on how these technologies will impact the industry.
1. Do you foresee AI and electronic health records eventually replacing source data verification (SDV), QC, and data entry members of the team?
Experts in the panel agree that AI and electronic health records (EHR) will eventually replace source data verification (SDV) in clinical trials.
AI will be used to manage or execute risk-based monitoring and help with better recruitment in trials, resulting in better efficiency, data quality, analysis, predictive analytics and lower costs. However, experts think that AI replacing SDV and data entry members of the team will take some time, and there may be some hesitancy in the industry due to the importance of study data.
“The technological advances in AI and blockchain has definitely had a positive impact in terms of the virtual or remote, or centralized monitoring of data sanity, data cleanness, and also source document verification. We are a little far away from seeing it replace manual data verification. However, with careful advances and some adjustments to the existing technologies and existing platforms, it is very well possible to replace the source document verification and the data review. Using the blockchain or even AI technologies, it is possible to manage or to execute risk-based monitoring for clinical research, if not a hundred percent source document verification.” - VP of Clinical Development and Medical Affairs, Pharmaceuticals
“I wouldn't say that it's a new feature but it’s becoming more evolved. The algorithms are becoming more evolved, even real-world evidence is being used with AI to develop better protocols for trials and really help with better recruitment on trials. So AI is continuing to have a role to play in different aspects, and certainly that will lead to better efficiency, better quality of data, better analysis, predictive analytics, and certainly lower cost, and faster speed to market for innovation.” - Global Vice president at Contract Research Organization
“My gut feeling is that there's going to be a combination. I think everybody thought electronic medical records, EMRs, were going to be the holy grail of the health system. And we found that they weren't, we found that they actually caused more work. So with the advent of AI and ChatGPT, you're going to improve these processes, not only with Natural Language Processing but also with the processes behind the scenes of eCOA electronic verification. And that's going to enable them to become much more efficient. But you're still going to need some physical intervention in the healthcare system at various steps along the way. It's just inevitable, people expect it, but they also are going to need it.” - Director of Business Development at Contract Research Organization
2. Will blockchain technology come to play an increasing role? If you believe this is the case, what are the benefits?
Many experts believe that blockchain technology will come to play an increasing role in various industries, including healthcare and clinical trials.
The benefits of using blockchain technology include increased security and transparency, streamlining the process of data collection and analysis, reducing the risk of errors and manipulation, and creating a single source of truth for data that is stored in a decentralized manner.
As the technology matures and the computing power catches up, it is expected that blockchain will make exponential impacts on healthcare and finance industries, among others. However, there are still challenges that need to be addressed, such as patient safety and data privacy concerns.
“So we already know blockchain has great applications in clinical trials. There is potential for it to provide security, making sure that the records and sensitive information of patient records or any IP remain secure as well as streamline the process of collecting and analyzing the data, reducing the risk of errors and manipulation that can happen. So I think there're definitely a lot of potential and I can see why there would be an increased role in the future.” - Director of Procurement, Pharmaceuticals
“I think blockchain, once it's mature and once the base computer power is in place to really take control or take advantage of blockchain, is going to make some exponential impacts on healthcare, on finance, on everything. I believe that healthcare is really the next great market that's going to benefit from this. Now there are some things that have to be done around patient safety, PHI (personal health information), GPR globally. How do we bring all this data together in a safe format that we can use for research? Right now it's still in silos where pockets of people own large swaths of data, whether it be prescription data, research data, patient information and hospitals. How do you bring all this together for the betterment of society or betterment of healthcare? And yes, life science companies are very involved in this.” - Director of Business Development, Pharmaceutical
3. Will open-source data continue to shape the industry, and help globalize trials?
All the experts unanimously agree that open-source data will continue to shape the pharmaceutical industry, as it enables sharing, collaboration and standardization of data. However, the same concerns discussed above, regarding security and privacy, need to be addressed.
Open-source data can also help in designing better clinical trials, and it can aid in globalizing trials by providing transparency and accessibility. It can add value at the market access level and help in making decisions related to insurance coverage and marketing.
There is a consensus among all the responses that open-source data will revolutionize the industry and aid in understanding the impact of healthcare interventions.
“The reality is this industry is very much data-driven and access to more data, to have more insight, is going to continue. I think it helps optimize drug discovery and drug development processes. Furthermore, pharmaceutical companies use this to streamline their sales and marketing efforts. From that perspective, it's probably going to continue to grow rapidly just because there's so much data that can be mined from patient records registry, real-world evidence, product sales, connected devices. I think it helps with treatment plans for patients and also helps improve clinical trial outcomes. So it's going to continue to evolve. With that said, obviously the more data, the more complex the information can be, and so how do you delineate and extrapolate the right information for the questions that you're trying to answer?” - Vice President, Enterprise Solutions, Pharmaceuticals
“Open-source data for clinical trials remains controversial. The quality of data that we are seeing in open-source trial information is not great. For understandable reasons - a lot of companies are not sharing their data. They feel it's priced and confidential and they can even monetize it. So there is difficulty in the quality of data that are being shared. Certainly, this will improve as more and more companies join in, more international global data becomes available. We should certainly see a better prognosis in the future and definitely stronger trials as well.” - Global Vice President at leading CRO company
In conclusion, experts believe that AI, blockchain and open-source data will play an increasing role in healthcare and clinical trials, making them more efficient, secure and transparent. Although there is still some hesitancy around these technologies, and many issues around privacy need to be addressed, experts agree that they have the potential to revolutionize the industry and aid in understanding the impact of healthcare interventions.
In addition to technological innovations in clinical trials, a curated panel of top experts on ArbolusChannels have been discussing diversity and representation, patient logistics and clinical tech providers. Get access to these insights - contact us to find out more.
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