Industry Trends in Clinical Development

Author: John Aggerholm – Project Director and Founder at HERAX

Introduction

Clinical development is undergoing a paradigm shift, driven by technological advancements and strategic innovations. Within the last few years, significant progress has been made in how trials are planned, executed, and managed.

This brief delves into four key trends shaping clinical development: Artificial Intelligence (AI), Clinical Site Portals, Decentralized Clinical Trials (DCTs), and the enhanced role of Clinical Trial Management Systems (CTMS).

Key Trends

Artificial Intelligence in Clinical Development

Artificial Intelligence has emerged as a cornerstone in modernizing clinical development, enhancing decision-making, and automating processes. The potential benefits AI brings to clinical trials are vast, ranging from improved patient recruitment, faster protocol development, and improved predictive modelling (incl. improved site selection, thereby improving enrollment, and shortening trial length).

Patient Recruitment and Retention

One of the most challenging aspects of clinical trials is identifying appropriate patient populations. AI can analyze large datasets from Electronic Health Records (EHRs) and Real World Data (RWD) to identify patient population areas and potential new sites, who will meet their enrollment criteria.

This capability reduces the time spent on recruitment and ensures a more targeted approach. Moreover, AI algorithms can predict the likelihood of patient dropout and suggest intervention strategies, thereby enhancing patient retention.

Data Analysis and Decision Support

AI plays a pivotal role in processing and analyzing clinical trial data. Machine Learning (ML) models can identify patterns and correlations within data that may otherwise go unnoticed.

These insights can inform critical decisions, such as optimizing trial protocols or identifying adverse event trends early. It is recommended to establish a dedicated capability group to explore AI and ML applications to drive decision-making and transform project execution.

Streamlining Operations

AI-powered tools also contribute to automating repetitive tasks, such as data entry and protocol compliance checks. Automation reduces human error, accelerates workflows, and allows research teams to focus on strategic activities.

AI can also check for and verify eTMF completeness, thereby ensuring better compliance and faster finalization of the eTMF.

Clinical Site Portals

Clinical site portals have become instrumental in enhancing interaction and collaboration between sponsors and clinical sites. These platforms offer a centralized interface for document exchange, training, and communication, ultimately easing the site burden.

These portals serve as a competitive differentiator for sponsors, facilitating clinical trial site interaction, document exchange, remote monitoring, and data quality improvement.

Several vendors today push the site portals for free to the sites. This approach is the same as initially used by sites like hotels.comand other travel sites. They signed up the hotels for free with the promise of more guests, but once they were used by most travelers, converted into a for pay model, now extracting a significant amount of the rental revenue from the hotels.

The same will happen with the large site portal vendors – once they have a critical mass with the sites, they will use this to have the sponsors and CROs pay for the access to the sites, expanding into site selection services and similar. They will own access to the site and will use this. It is a situation the sponsors and CROs do not want to get into. It is important that multiple site options are maintained.

The Role of Single Sign-On (SSO)

A critical feature of efficient site portals is Single Sign-On (SSO), which simplifies access to multiple systems, such as EDC, IRT, eConsent, and eCOA in the same study. SSO not only improves usability but also fosters a stronger relationship with site staff, making the sponsor a preferred partner.

Streamlining Document Exchange

Traditional methods of document exchange, such as emails and physical copies, are cumbersome and error prone. Site portals equipped with eSignature functionality and automated workflows mitigate these challenges. The portal supports creating a seamless document lifecycle to enhance efficiency, consistency and compliance.

Enabling Remote Monitoring and Training

As decentralized trial models gain traction, site portals are increasingly offering features like remote monitoring and virtual training sessions. This capability reduces the need for on-site visits and accelerates study start-up processes.

Moving into a digital first approach reinforces the need for process optimization. Still a pure digital approach will not work, as the relationship with the site will suffer. It is important to maintain physical presence at the sites, to foster a good site relationship.

Decentralized Clinical Trials (DCTs)

Decentralized Clinical Trials represent one of the most transformative trends, bringing trials closer to patients through virtual and hybrid models. This trend widely adopted during Covid, is not only improving patient accessibility but also redefining traditional trial methodologies.

Decentralized Capabilities

Technologies such as eConsent, eCOA, and telemedicine are at the core of DCTs. These tools enable patients to participate in trials from the comfort of their homes, reducing the physical and logistical barriers to trial participation.

A digital first DCT approach underscores the importance of leveraging these capabilities to enhance patient retention and engagement.

Data Integration and Real-Time Insights

Decentralized trials generate a significant amount of data from disparate sources. Integrating this data into central repositories, such as Clinical Data Warehouses (CDWs), is essential for real-time monitoring and analytics.

Clinical Trial Management Systems (CTMS)

Clinical Trial Management Systems (CTMS) are the backbone system of Clinical Operations, evolving from mere data repositories to strategic tools. CTMS oversee trial operations and can streamline processes, providing critical insights into trial recruitment, treatment status, and site performance within data compliance, patient retention and quality issues.

Enhanced Functionalities

CTMS platforms offer functionalities for not only monitoring, but also milestone tracking, site budgeting, feasibility modules and automated reporting. These features provide a single source of truth for trial-related information, improving transparency and decision-making. Optimizing CTMS capabilities is also a priority for enhancing portfolio planning and resource management.

The most efficient use of CTMS data is historical site enrollment numbers. This can be used for selecting the most effective sites, not only the ones over enrollment, but also the ones delivering on how many patients have been agreed they should enroll. By using this information for new studies in site selection, a more precise enrollment can be both predicted and ensured, thereby shortening the trial execution time.

Shortening the trial execution time is the most effective real cost saver. And the data for doing this work all comes from a good CTMS system.

Integration with Other Systems

CTMS platforms are increasingly integrated with other IT systems, such as eTMF, EDC, eCOA, eConsent, AI and data visualization tools. This integration minimizes data silos and ensures that trial teams have access to comprehensive insights. A standard approach to integration, facilitating better data flow and reporting are required when bringing new systems, labs and CRO onboard.

Scalability and Compliance

As clinical trials grow in complexity, scalability and compliance become critical, CTMS solutions must support large-scale trials while adhering to stringent regulatory standards.

Few CTMS systems can truly automate all the operational processes, and interface with multiple vendors. Make sure your CTMS system is one of those.

Conclusion

The landscape of clinical development is being reshaped by technological advancements and strategic innovations. Artificial Intelligence, Clinical Site Portals, Decentralized Clinical Trials, and CTMS are becoming essential pillars for the effective planning and execution of clinical trials, and at the same time reducing the costs.

By embracing these developments, sponsors and CROs can streamline operations, plan and execute the studies better, with faster patient recruitment, and thereby shorten the trial length and save costs. The synergy between these trends, underpinned by robust IT strategies, promises more efficient studies in clinical development.

In the years to come, the industry must continue to invest in these areas, ensuring that technological progress aligns with the overarching goal of improving global health.

About the author

The brief author John Aggerholm has worked in the clinical development and operations space for more than 30 years. With experience from multiple top 10 pharma and device companies and having worked with large eClinical digitalization programs as a consultant for the last 16 years, John knows what systems and vendors can really deliver value to sponsors, in the area of Clinical Development.

Should you have any questions or need for assistance, please do not hesitate to contact HERAX Life Science on [email protected].