Real-World Evidence Insights - 05.12.24

RWD Tech Updates

Seeing Firsthand The Transformative Impact Of AI On Pharmacovigilance And Clinical Research

AI is revolutionising pharmacovigilance and clinical research by enhancing data processing and decision-making. Tools like ARIS G and ARGUS improve safety monitoring, while AI accelerates patient recruitment and trial design. Emphasising ethical considerations, this technological advancement offers safer, effective therapies, fostering a proactive, patient-centred healthcare future.

The Hidden Drivers Of Clinical Trial Success

Chintan Desai of Stryde Research highlights that clinical trial success hinges on adaptive resource management, financial intelligence, and integrated quality. Effective sites optimise existing systems and blend technology with the human touch, enhancing trial performance and participant support. Successful sites focus on operational creativity and seamless capability integration.

Digital Twins Could Augment Clinical Research, Help Ease Data Disparities

Digital twins in healthcare are set to revolutionise clinical trials by leveraging AI simulations. These virtual replicas can predict patient outcomes, ensuring more equitable data representation, particularly for underserved groups. Early adoption by companies like Bayer highlights their potential in improving precision medicine and addressing data disparities.

Complexities with Managing Clinical Technology

Jeff Sidell, PhD, of Advarra highlights the challenges clinical research faces due to an overabundance of technology. With sites managing up to 20 systems, integration is crucial to streamline operations. The potential of AI, like predictive analytics, offers an opportunity to automate tasks, boosting efficiency and care quality.

Regulation Spotlight

Regulating Professional Ethics in a Context of Technological Change

Healthcare professionals encounter numerous challenges, particularly regarding ethical considerations tied to artificial intelligence. This research, conducted in Ontario, sheds light on the sluggish evolution of regulation in this area. Despite the evident need for robust guidance, existing codes currently emphasise general principles rather than providing clear directions for navigating technological advancements.

Health practitioners often grapple with conflicts between their employer's requirements and regulatory expectations, leading to uncertainty in practising ethically in the digital age. Regulatory bodies are tasked with protecting public interest yet struggle to keep up with rapid tech progress, leaving professionals searching for more comprehensive support. Research findings highlight an urgent demand for enhanced regulation and guidance on technology use in healthcare settings.

Conversations with practitioners reveal both excitement and trepidation around AI's potential, urging a balanced approach that encourages innovation without compromising ethical standards. Collaborative efforts among regulators, practitioners, and stakeholders are essential to address these complex issues and ensure ethical practices prevail alongside technological growth. It's clear that bridging these regulatory gaps will be crucial for healthcare professionals to embrace technology confidently while maintaining ethical responsibilities.

Industry News

2024 Familiar Problems Encouraging Progress

In 2024, the clinical trial industry addressed challenges in site capacity and enrolment with promising innovations. Despite workforce restructuring causing concerns, progress included enhanced site infrastructure and technology integration. Stakeholders are urged to focus on nurturing site growth and investigator development to sustain advancements while addressing enrolment issues.

Breaking Bottlenecks in Clinical Trials: Insights from Bryan Spielman

The article discusses the barriers in clinical trials, emphasising the need to accelerate study start-up processes. Key challenges include delays in regulatory approvals, technology set-up, and participant enrolment. Advocating for harmonisation and technology use, the article highlights ways to improve efficiency, reduce costs, and enhance patient engagement.