The life sciences industry is generating an increasing number of data points a day. While this data is essential to helping organizations make insight-informed decisions about critical operations, such as in clinical trial development, it is also proving to be a complex and daunting task, taking a significant toll on sponsors and clinical sites. In their quest to streamline operations, enhance efficiency, and optimize outcomes, life sciences, like many other industries, is embracing AI as a transformative force. The technology is showing specific benefits in clinical trial development. Let’s explore how trial sponsors and sites can accurately leverage modern AI to improve trial outcomes.

Navigating the Data Deluge in Clinical Trials

Clinical trials, especially late-stage, can leverage 10 data sources and generate an average of 3.6 million data points – that is three times the number reported 10 years ago. The reality is that complexity continues to hinder the success of clinical trials. In fact, with some studies using around 22 different systems to engage with clinical trial data, it becomes even harder to access and distribute essential data including electronic medical records (EMRs) and administrative and research data.

All the information collected must be managed and accessed by sponsors, contract research organizations (CROs), and site staff throughout the course of a trial. The continuous influx of information and the proliferation of digital touchpoints can lead to data interoperability challenges, information overload, and mismanagement of patient data that are essential for the success of clinical trials.

An added challenge is finding the time and resources to thoroughly analyze all the data. This does not only affect informed decision-making but impacts the site staff’s work and the patient outcomes, and can lead to deviations in the results and longer timelines for the clinical trial. This is where AI holds tremendous benefits. However, it is crucial to recognize that AI is not a plug-and-play solution.

Organizations must first establish efficient processes to fully harness the power of AI. They must ask themselves whether they have a strategy for digitization and automation, how it will impact data access and maintenance in relation to their current systems, and how to maintain compliance and privacy standards.

Foundational Elements for Successful AI Deployment

A critical aspect of the success of AI is understanding the specific business processes where AI can be implemented. Processes that are inefficient, disconnected, or manually executed will not automatically achieve improvements just by applying AI. In fact, unfavorable outcomes may arise. Specifically, organizations should look to implement systems that build long-term success and enable AI to thrive, including:

• Digitization: This process serves as the first step in transforming information into machine-consumable data and workflows that can be seamlessly integrated with other systems and technologies. This shift begins with a thorough analysis of processes across the clinical trial from study start up to finish.
• Standardization: This process involves implementing connected data standards, ensuring that information from different sources can be seamlessly integrated, analyzed, and interpreted. In a clinical trial ecosystem, this step is essential to confirming data remains accurate and consistent throughout a trial’s lifecycle. 
• Centralization: This process establishes a “single source of truth” by leveraging a centralized data repository (CDR). This repository should come equipped with integrated data-browsing and tracking capabilities, empowering seamless utilization of harmonized data by all trial stakeholders. Such unified data access proves invaluable for diverse purposes, including modeling and forecasting.

By establishing a solid foundation for AI implementation, organizations minimize risks and increase the chances of successful outcomes leveraging the technology.  

Streamlining Data Analysis Through AI and Generative AI

Harnessing the capabilities of AI, companies are optimizing clinical trial processes by providing decision-making teams with validated, accurate real-time data. This expedites drug development, reduces the risk of data discrepancies, enhances staff productivity, and elevates the overall quality of data collection.

Biopharma organizations, for example, are integrating AI throughout the lifecycle of their assets, leading to heightened success rates, accelerated regulatory approvals, reduced time for reimbursement, and improved cash flow from the entire clinical trial process. 

AI is also instrumental in facilitating faster document submission to the Trial Master File – a collection of documents proving that the clinical trial has been conducted following regulatory requirements. Ultimately, enhancing data quality, identifying beneficial sub-populations and predicting potential risks in clinical trials. 

As we transition into the generative AI era, the life sciences industry is experiencing a favorable transformation as well. Notably, this shift brings accelerated insights, such as chat interfaces, faster solution development through new engineering tools, enhanced detection of inconsistencies, and a swifter process of document authoring. These advancements contribute to increased efficiency in tasks like protocol creation and safety narrative generation, marking a positive stride in the overall impact of generative AI across various clinical trial elements.

The Future of Data Analysis in Clinical Trials

AI’s role in streamlining clinical trial development is to provide numerous benefits for all stakeholders, including reduced staff burnout, freed-up time and resources, and optimized trial outcomes. 

By establishing a solid foundation for AI deployment, this technology can be transformative in the generation, management, and distribution of safe, accurate, and compliant data. Bottom line: The automation of workflows from study start to finish will help advance and accelerate the development of lifesaving therapeutics that will benefit patients globally.