Real-World Evidence (RWE), the clinical insights derived from analyzing Real-World Data (RWD)—such as electronic health records, claims databases, and patient registries—is increasingly employed as a foundation for the design of clinical trials.
The relevance of RWE is increasingly recognized on a global scale and the FDA and EMA have been at the forefront of this movement. Their representatives have strengthened efforts in weaving RWE into their decision-making protocols, and such integration helps ensure that regulatory processes benefit from a wider array of data sources—not only traditional clinical trials.
We believe that the potential of RWE in clinical research will continue to grow in 2024 due to its ability to support regulatory submissions, facilitate evidence-based decision-making, and expedite the availability of new treatments to patients.
Data insights into biological processes and responses to treatment, such as blood pressure or cholesterol levels, are integral to clinical trials. Recent technological advancements have brought forth the discovery of newer, more intriguing biomarkers, including digital biomarkers and novel blood biomarkers, which will make a splash in the clinical trials industry in 2024 and beyond.
In a nutshell, digital biomarkers, from devices like wearable technology (fitness trackers, smartwatches, wearable ECG monitors, biosensors, and even GPS trackers), offer objective and continuous measurements of physiological and behavioral parameters, ranging from sleep quality to voice and speech patterns, throughout the day with minimal input needed from the patient.
By incorporating these advanced biomarkers into clinical trials, researchers can enhance patient stratification, improve treatment monitoring, and speed up the development of targeted therapies. Sponsors and Contract Research Organizations (CROs) can also integrate them to gain insights into specific disease mechanisms and enable personalized treatment approaches.
Mobile devices (such as smartphones and tablets) enable patients to capture such data on a device they are already familiar with. Viedoc Me, our web-based solution for electronic patient-reported outcomes (ePRO), enables patients to report clinical trial information directly from their mobile devices into the electronic case report forms (eCRFs) available in Viedoc.
In 2024, the healthcare landscape will intensify its focus on health equity, driven by awareness of persistent disparities. Enhancing representation from remote and underrepresented communities, recognizing the importance of inclusivity for generalizability.
Exclusion may lead to skewed outcomes, exemplified by the heightened risk of adverse reactions in diverse ethnic groups. Incorporating various demographics fosters equity, accessibility, and addresses health disparities, enhancing real-world applicability.
The discourse aligns with Viedoc's commitment to healthcare accessibility, showed by our free license offer in support of the United Nations 2030 Agenda. CROs, sponsors, and institutions can apply for licenses to contribute to finding cures for deadly diseases.
Decentralized Clinical Trials (DCTs) will continue to grow in importance to the clinical trials industry in 2024. The importance of DCTs lies in their ability to overcome geographical limitations, enhance patient participation, and generate real-world evidence.
By enabling patients to conveniently send data from the comfort of their homes through user-friendly interfaces, Viedoc Me enhances patient engagement and compliance, addressing potential barriers that could hinder the success of decentralized trials. This not only streamlines data collection but also ensures the reliability and integrity of patient-reported information, contributing to the overall success and credibility of decentralized clinical trials.
The integration of electronic Patient-Reported Outcome (ePRO) and electronic Clinical Outcome Assessment (eCOA) solutions like Viedoc Me can make DCTs even more efficient and patient centric.
Using Viedoc Me helps foster a seamless and patient-friendly experience. Its integration not only reduces the burden on participants but also facilitates real-time data capture, enhancing the quality and timeliness of clinical trial data.
The significance of robust and transparent reporting in clinical trials cannot be overstated. The ability to generate transparent and interpretable reports is instrumental in aiding researchers, clinicians, and regulatory bodies in making informed decisions about healthcare interventions. Additionally, in an era marked by increasing data complexity and evolving regulatory requirements, transparent reporting in clinical trials becomes indispensable for meeting stringent standards for transparency and documentation.
Viedoc Designer utilizes R programming for statistical analysis and data visualization, contributing to the integrity of clinical trial outcomes. Transparent reporting not only ensures credibility but also supports scrutiny, reproducibility, and collaboration within the scientific community. R's versatility allows for the integration of diverse data sources and the creation of dynamic, interactive reports, providing a comprehensive view of study results. This transparency not only meets regulatory expectations but also fosters a culture of openness and accountability within the research community. Viedoc Reports help data managers focus on what’s important. Being able to zoom, sort, search, compare, cross-check, and export data makes it easy to view and predict study progress, and enables them to draw valuable conclusions about trends and patterns in their trials.
Initiatives driven by data will play a crucial role in hastening clinical trials in 2024, fostering the development of more effective treatments, and enhancing patient outcomes. Utilizing data analytics and artificial intelligence enables researchers to delve deeper into disease mechanisms, facilitating the design of targeted clinical trials and the creation of effective therapies. Adopting a data-driven approach accelerates drug development, enhances treatment precision, and improves patient lives.
Artificial Intelligence (AI) and Machine Learning (ML) algorithms can sift through vast datasets, identifying patterns imperceptible to human researchers, potentially enhancing the accuracy and efficiency of clinical trials.
Clinical study protocols will be supported by using advanced tools like Large Language Models (LLMs) to synthesize internal sponsor documentation, incorporating earlier pre-clinical and clinical study results, along with adherence to regulatory requirements and therapeutic guidelines.
Configuring Electronic Data Capture (EDC) systems with AI involves leveraging Natural Language Processing (NLP) to extract key information from clinical trial protocols and generate a comprehensive data dictionary. Using this data, AI algorithms can then automate the configuration of the EDC system, dynamically creating forms, defining case report forms (CRFs), and implementing user roles. Quality control mechanisms ensure alignment with the protocol, and AI-driven support tools aid user training and provide real-time assistance. The adaptive learning capabilities of AI continuously optimize the EDC system based on user interactions and evolving study requirements. Integration with external systems and adherence to compliance and security standards complete the process, offering a streamlined and efficient approach to clinical trial data management.
These tools will help streamline the process to pave the way for automating the setup of study designs. The use of AI, ML, and LLMs has been a hot topic for the clinical trials industry in 2023 and will doubtlessly continue.
Interested in learning how Viedoc’s eClinical suite can advance your trials in 2024 and beyond? Contact us here for a demo.
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