Industry Insight

Dr Harsha Rajasimha from Jeeva Informatics considers how digital innovations and decentralisation can improve clinical trials

Technolog y has significantly impacted the way clinical trials have been conducted over the last few years. The operational efficiency of clinical trials has been deteriorating even despite exponential growth in technological advances. It was difficult to reconcile the two until recently.

Massive digital transformation initiatives in clinical trials infrastructure have focused on improving speed, efficiency and accessibility of clinical trials. Technology platforms for clinical trials have lacked human-centric approaches, however this is now showing signs of improvement.

Further, the advent of artificial intelligence (AI) and its integration into the clinical trial processes is leading to improvised workflows and efficiency. Online tools such as remote e-consent and video capabilities have improved remarkably and have given an edge to the patient-centric approaches by minimising travel burden. AI and the platforms that conduct the clinical trial are complementary. Together, they ease the burden of clinical trial barriers. As clinical trial stakeholders accept the priceless benefits of what the digital world has to offer, we welcome a new era of patient-centric and data-driven clinical research.

Assessing if there is a genuine need for technolog y in research provided a thorough understanding of the complexities and problems clinical trials can face, for example:

• Meeting strict regulatory requirements and guidelines

• The accuracy and integrity of the data gathered during the clinical trial

• The lengthy and difficult process to find matching participants for a clinical trial

• Logistics, coordination and managing the operational aspects of a trial for which protocol has already been finalised and handed over to an operations team, which sometimes complicates the process.

Barriers to successful clinical trials can include:

• The information systems needed to execute a clinical trial are fragmented, and it can be extremely challenging to consolidate trial data from multiple validated point solutions in one place

• With multiple investigator sites and stakeholders involved in the clinical trial process, the lack of streamlined communication between them leads to further delays and inefficiencies

• Managing protocol complexity and manual repetitive processes can add to the inefficiencies.

Before technology made its way, data entry was done manually and on paper. Needless to say, the process was error-prone, slowing down clinical research significantly. Some concerns that were consistently seen prior to the use of AI and digital technology include:

• Maintaining a fully validated platform with regulatory compliance requires extensive testing, quality control, validation and documentation with standard operating procedures slowing down any new enhancements desired to support a unique clinical trial protocol requirement

• When there is no technology involved, it reduces the flexibility and adaptability of research protocols. This leads to rigidity in trial execution.

Effective incorporation of AI throughout the clinical research continuum is the need of the hour. It's time to call for accuracy and advanced data management through the adoption of human-centric tools. There is no better time than now for empowering participants and prioritising patient-centric approaches by complying with US Food and Drug Administration (FDA) guidance on decentralised clinical trials.

Effective implementation of AI can minimise manual repetitive tasks and a human-centric unified digital platform can improve efficiencies and user experience in clinical trials. Collectively, AI-driven unified clinical trial management platforms can streamline the entire process and enable research participants to contribute from the comfort of their homes. With real-time gathering of data, sponsors can take corrective and preventive action including outcomes reported by the participants.1

A well-designed platform solution can enhance data transparency and earn the trust among the research participants. With a patient portal that can engage participants and share their data with them at all times, if undertaken in the right way, these strategies can maximise participant engagement and retention throughout the trial and even during the follow-up.

Sensitive patient data and information needs to be protected by robust data protection methods including data encryption at rest and during transmission. Data security is the cornerstone of technolog y-driven research enabling the ethical practice of medicine by protecting participant safety. By using an isolation strategy for security incidents to each user, data element or study, platforms can minimise the risks of security breaches that cannot be avoided.

In light of the need for digitalisation and decentralised tools, there are many benefits to their use.

Nothing can be more comfortable for a research participant than actively partaking in the trial from the comfort of their own home. Remote video capabilities have allowed participants to engage with the research process from their homes. E-consent solutions have streamlined the consent process, making it more accessible and convenient for participants.

To ensure continuous support and real-time data monitoring, mobile applications and telemedicine have come to the rescue. The integration of electronic clinical outcomes assessments (eCOA) and ePRO modules simplifies the process of collecting patient-reported data, ensuring a comprehensive understanding of participant experiences.

Overall, these decentralised tools have made research studies more accessible and inclusive. Active patient involvement has amplified the significance of participant experiences, promoting a patient-centric approach to clinical research.2

Moving ahead with decentralised clinical research tools, there is always a collective vision of clinical researchers. A vision to improve patient outcomes and global health standards. Collaboration among pharmaceutical sponsors, research organisations and regulatory bodies is integral to the advancement of clinical trials.

With patient-centric approaches, decentralised clinical trials can ensure the safety and experiences of patients. With greater research, come better solutions to the health concerns of the research participants.3

With decentralised clinical trials and their technolog y integration, it is possible to encourage more patients to take part. Retention would not be such a problem if processes and user interfaces remained simple. Real-time data monitoring and constant communication with healthcare professiona ls is possible, making the entire process hassle-free. On the horizon, we can see greater research, greater collaboration and accelerated drug development with universal accessibility. It is a promising time in the world of clinical trials.

In conclusion, technolog y has opened the gates of a more secure, protected, patient-centric and data-transparent era in clinical trials. The integration of AI-powered unified clinical trial management platforms with decentralised capabilities is accelerating the clinical research process.

AI-driven technolog y has redefined patient engagement. It has amplified the role of participants in the research ecosystem and it has ensured inclusion and collaboration, which are the key principles of health research. To sum up, the future of clinical trials holds promise for unprecedented growth and innovation in the next decade.

References

1. Visit: ncbi.nlm.nih.gov/pmc/articles/PMC8093545/
2. Visit: sciencedirect.com/science/article/pii/S1359644623000363?via%3Dihub
3. Visit: ebm.bmj.com/content/28/5/328