In the wake of COVID-19, clinical trials deserve our attention more than ever. If there’s one thing to be learned from the pandemic years, it is that effective development and testing of drugs and vaccines can have a tremendous impact.  

The success of such developments, however, hinges on even the smallest factors. This is why the administration of clinical trials is as important as the scientific detail: participants need to be selected and briefed as efficiently and effectively as possible, a process which can be optimised using automation technology.  

To further understand these possibilities and their benefits, we spoke to Dan Herron, VP of digital offerings at RWS, to learn more.  

Q: What are some of the ways in which automation technology is driving positive change in the clinical trial sector? 

Herron: In large-scale clinical trials involving thousands of patients, manual data collection on paper is time-consuming and susceptible to human error, risking the integrity of the data. The introduction of electronic data capture (EDC) systems is a game-changer. These systems automate the collection and storage of patient data electronically, with built-in validation checks to enhance data reliability. 

Q: What problems can arise by failing to optimise workflows, or make improvements to efficiencies? 

Herron: Without automation, research staff may spend significant time reviewing patient records one by one to identify eligible participants, generating unnecessary delays and expense. 

Automation can address this challenge through the implementation of automated patient screening algorithms. These algorithms quickly analyse patient records, identify eligible candidates based on predefined criteria, and produce a list of potential participants, thus streamlining the recruitment process.  

Additionally, the use of automated algorithms can improve the accuracy of translation services for multilingual recruitment and communication with potential participants. 

Q: How can automation help to lower the overall cost of clinical trial operations? 

Herron: The adoption of automation tools like Component Content Management System (CCMS) and platforms such as RWS’s Fonto Integrated Authoring Platform (IAP) opens significant avenues for cost savings. Fonto IAP innovatively merges structured, componentised content with user-friendly, data-driven authoring, using AI to boost efficiency. 

Furthermore, the integration of translation management systems (TMS) simplifies the translation of trial materials. This not only leads to cost optimisation but also ensures consistent language use across various countries where trials might be taking place. 

Q: How has automation impacted processes such as patient consent and COA (Clinical Outcome Assessment) documentation?  

Herron: These processes are critical for maintaining regulatory compliance and ensuring data accuracy. Automating them with electronic consent (eConsent) platforms ensures that all necessary information is presented to patients in a clear and standardised manner, thereby reducing the potential for regulatory non-compliance and legal issues. 

Q: How does Electronic Clinical Outcome Assessment (eCOA) improve data quality and compliance in clinical trials? 

Herron: eCOA solutions enable participants to input their patient-reported outcomes (PROs) directly, eliminating the need for manual transcription from paper forms which often produces errors and data inaccuracies.  

Furthermore, these systems include built-in checks and reminders, enhancing patient compliance with data reporting requirements. As a result, data quality improves, and the likelihood of data inaccuracies decreases, contributing to more reliable and compliant clinical trial results. 

Q: When it comes to streamlining processes, where does translation come into play and how important is it that this is built into operations? 

Herron: In global clinical trials, effective translation plays a vital role in ensuring that all participants can understand and engage with trial materials, regardless of their native language. Failure to incorporate translation effectively can lead to misunderstandings among participants, which can inhibit the trial’s success and even the validity of results depending on the ethical and regulatory implications. 

Effective translation in global trials involves not only translating content accurately but also considering cultural nuances and regulatory requirements specific to each region. Automation in translation can expedite this process by leveraging machine translation tools and management systems alongside human review to maintain linguistic and contextual accuracy. 

Machine translation tools can quickly and cost-effectively translate large volumes of documents into multiple languages. Integrating human review and validation into the process ensures accuracy and compliance with regulatory standards. 

Furthermore, translation management systems can automate project management tasks, thereby streamlining the translation workflow, reducing overheads, and guaranteeing timely translations. 

Q: How does RWS help to build inclusive trials and increase patient engagement?  

Herron: RWS Life Sciences offers a comprehensive service in translating patient-facing materials, such as study brochures, informed consent forms, and instructions, into multiple languages so that all participants can fully understand the trial’s requirements and procedures. 

RWS focuses on cultural adaptation and linguistic validation to ensure that translated materials resonate with everyone. By making trials more inclusive, organisations can enhance patient engagement and diversity in clinical trials, ultimately leading to more robust results. 

Another notable advancement from RWS is the introduction of our Evolve service, a cutting-edge linguistic AI innovation by Language Weaver. Blending human expertise and artificial intelligence, with Evolve the translation of complex clinical documents can be done much faster, achieving near human-like quality. This technology is crucial in ensuring the easy and efficient organisation of global clinical trials. 

Q: How do you see automation playing out in the industry over the coming years? 

Herron: The use of AI chatbots is going to be significant: they can interact with potential participants, answer their questions, assess eligibility criteria, and schedule screening visits 24/7, significantly accelerating the recruitment process. 

Advanced analytics and machine learning algorithms will be leveraged to analyse large datasets from clinical trials. Additionally, automation tools will assist in managing the increasing complexity of regulatory documentation and submissions, reducing the risk of non-compliance with evolving legislation and speeding up the regulatory approval process. 

Overall, automation will remain pivotal in expediting the drug development process. It will be a driving force for innovation and efficiency in the industry over the coming years. 

To learn more about how RWS can help you in the effective administration and automation of clinical trials, download the whitepaper below.