Advanced technologies such as artificial intelligence (AI), machine learning (ML), and natural language processing (NLP) have become a cornerstone of successful modern clinical trials, integrated into many of the technologies enabling the transformation of clinical development.

The health and life sciences industry’s dramatic leap forward into the digital age in recent years has been a game-changer with innovations and scientific breakthroughs that are improving patient outcomes and population health. Consequently, embracing digital transformation is no longer an option but an industry standard. Let’s explore what that truly means for clinical development.

An accelerated path to better results 

Over the years, technology has equipped clinical leaders to successfully reduce costs while accelerating stages of research and development. These technologies have aided in the structurization of complex data environments—a need created by the exponential growth in data sources containing valuable information for clinical research.

Today, the volume, variety and velocity of structured and unstructured data generated by clinical trials are outpacing traditional data management processes. The reality is that there is simply too much data coming from too many sources to be manageable by human teams alone. As a response to this, AI/ML technologies have proven in recent years to hold the remarkable potential to automate data standardization while ensuring quality control, in turn easing the burden on researchers with minimal manual intervention.

Once the collection and streamlining of data is compiled within a single automated ecosystem, clinical trial leaders begin to benefit from faster and smarter insights driven by the application of machine analysis. These include the creation of predictive and prescriptive insights that can aid researchers and sites to uncover best practices for future processes. Altogether, these capabilities can improve research outcomes, patients’ experience and safety.

A look into compliance and privacy 

When we think about the use of patient data, privacy and compliance adherence must be a consideration. The bar is set high for any technology being implemented into clinical trial execution.

Efforts must adhere to Good Clinical Practice (GcP) and validation requirements that ensure an outcome is valid by it being predictable and repeatable. Additionally, there must be transparency and explainability around how any AI algorithm makes decisions to prove correctness and avoidance of any potential bias. This is becoming more essential than ever from a compliance perspective as regulators look at algorithms as part of what they base their approvals on.

Keeping the h(uman) in healthcare 

The goal of implementing AI/ML in clinical research is not to replace humans with digital tools but to increase their productivity through high-efficiency human augmentation and the automation of mundane tasks. Before the application of advanced technologies to clinical trials, there was an unmet need for an agile methodology where researchers and organizers could solely focus on critical requirements and the delivery of results.

The intelligent application of technology allows for human interaction with AI models to bring better outcomes to research, and even in its most advanced stage, data science technology never replaces the human data scientist. It does, however, provide a mutually beneficial circumstance wherein the augmentation of workflows allows data scientists to ease data burden while AI models flourish through human feedback. This continuous learning by an AI model is known as Continuous Integration/Continuous Delivery (CI/CD).

The integration of human capacity and technology results in accelerated efficiency, improved compliance and superb patient personalization. Furthermore, regardless of how efficient algorithms become, the decision-making power will always belong to humans.

Envisioning a bold future 

AI/ML strategies are redefining the clinical development cycle like never before—and as the industry leaps into new frontiers, digital transformation is leading the way to incredible advancements that will revolutionize the space forever. Leaders today have the opportunity to apply advanced technologies to solve historically complicated problems in the field.

Already, we’ve seen better site selection, more effective risk-based quality management, improved patient monitoring and safety, enhanced patient recruitment and engagement, and improved overall study quality—and this is just the beginning.

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