The Evolving Role Of Technology In Clinical Trials – In Putting Patients First
As a result of the pandemic, and media coverage of different vaccines and approvals, there is more knolwedge than ever before about clinical trials which has led to increased patient involvement. This is clearly seen in a Google Trends report which shows that searches for “clinical trials” reached a peak in India between June 28 and July 4, 2020.
Along with this burgeoning interest in clinical development, we’ve witnessed increased adoption of technology in the clinical trial space as a result of the pandemic. Mobility restrictions and clinical trial participants reluctance to travel has led clinical research staff to increase remote monitoring and emphasized the need for virtual trials.
The emergence of new technologies and ways of conducting clinical trials will likely be transformational for the industry. We outline the steps needed to ensure that there’s “No Going Back”.
New technologies/processes
The pandemic has propelled the emergence and adoption of new technologies designed to reduce patient burden in participating in clinical trials. This includes leveraging digital modalities (laptops, smartphones, etc.) to gain consent from participants (eConsent), collect data directly from the patients homes through wearables/sensors and electronic patient-reported outcomes (ePRO), and in some cases, substituting physical visits with telemedicine consultations. All of these are broadly classified under the umbrella of decentralized clinical trials.
Another idea gaining traction is using real world data to determine effectiveness of new therapies. Traditionally, patients in clinical trials are part of a very controlled set of procedures; however, the question that is being asked today is if the “real-world” data from regular hospital visits / insurance claims etc. can be used to evaluate if a new therapy works – thereby removing (or at least reducing) the need for a “randomized controlled” new study. This has the potential to dramatically change the way clinical trials are conducted in the future.
Developing new skills to adapt to the changing technology requirements
While the above changes are exciting, these advances need to be balanced with upskilling to adapt to the new ways of doing things. Patients need to learn how to self-assess and upload their data. Research professionals need to learn how to collect and analyze this new type of data. Existing infrastructure needs to be upgraded. Investigators (who are doctors first, and clinical research professionals second) need to understand the importance of collecting complete data in a format that might be unfamiliar. All this requires training, and a mindset shift.
Collaboration between Clinical Research Organizations (CROs) and industry sponsors
While there is agreement on the need to develop patient centric trial processes, the execution of these technologically advanced processes is not likely to be easy. Success can be achieved only by establishing strong partnerships between industry sponsors and CROs. Rather than wait until the perfect solution is established, it is crucial to move forward with the right intent, and integrate the best possible solutions along the way.
Experience has taught us there are multiple facets involved in bringing virtual trials to the real world and technological tools will play an important role in making the overall system robust and risk-free. Most importantly, we are confident adoption of these tools will enable the industry to move towards a patients first world.
About the author -
Mahesh Iyer - Vice President, GDO Innovation Lead and GDO India Head at Parexel International
