Randomization in clinical trials is essential for reducing selection bias among participants and ensuring robust and reliable results. Solventum, a leading medical device company, has revolutionized this vital process by utilizing the Zelta by Merative eClinical platform, introducing an innovative approach to randomization that has garnered attention across the industry. Recently, Solventum shared their experiences in a comprehensive webinar led by Krista Dahling, Supervisor of Clinical Data Management, outlining how their methods have significantly increased efficiency and reduced bias in clinical trials.
The Need for Novel Randomization Approaches
Addressing Unique Challenges in Clinical Trials
Traditional eClinical platforms have streamlined the process of randomization in clinical trials. However, the need for novel approaches became evident as Solventum faced unique challenges in their diverse range of studies. Managing around 45 clinical trials globally, Solventum conducts about two-thirds of these studies in dental and healthcare facilities, while approximately one-third are organized in-house. Conducting trials internally helps eliminate the need for site selection, reduce training requirements, and enhance overall efficiency. This necessitates rapid and accurate trial processes, a demand that Zelta’s platform meets effectively.
Dahling described their creative and novel approach in a particular clinical trial wherein teeth were enrolled as individual subjects. In this trial, participants could have one tooth enrolled at a time and return later to enroll additional teeth, up to a maximum of five per participant. This unconventional trial design required considerable problem-solving and innovative thinking. Zelta’s flexible platform was pivotal in allowing the teeth to be linked to a subject’s ID independently, effectively avoiding duplicate data entry and ensuring accurate recording of each trial session. Furthermore, using Zelta’s randomization model, teeth were paired with others of similar size through defined stratifications, which maintained the integrity and consistency of the trial data.
Enhancing Efficiency with Customized Trial Models
Constructing a trial process from scratch to handle such complexities would generally be an overwhelming task. However, Zelta’s Electronic Data Capture (EDC) platform supports customized trial models designed to fit specific needs, significantly simplifying this process. For Solventum, employing Zelta’s ability to import data from previously built studies and extensive clinical libraries drastically reduced the time spent on trial builds, proving invaluable in meeting tight schedules and efficiency demands. Solventum’s success metrics hinge on the number of studies that can meet internal timelines, demonstrating the critical nature of efficiency in clinical trials.
Previously, Solventum manually designed data entry screens to match paper sources, which inevitably consumed considerable time and increased the potential for errors. The transition to direct data entry via Zelta revolutionized this process, making screen creation more efficient and offering substantial advantages. Dahling underscored the benefits and time-saving aspects of Zelta’s methodical screen flow, which made data entry effective and significantly reduced error rates. Additionally, the ability to correct errors in real time proved immensely valuable, further saving time and resources and leading to cleaner, more accurate data.
Reducing Bias and Improving Quality in Clinical Trials
Streamlining Trial Processes with Zelta’s EDC Platform
Another significant advantage Solventum realized through the use of Zelta by Merative is the platform’s capability to streamline trial processes. During the trials, ensuring that each step flows seamlessly is crucial in preventing delays and maintaining high-quality standards. Zelta’s EDC platform offered a robust solution for this, with features that support the smooth execution of complex trial designs without compromising the integrity of the collected data. In the unconventional trial where teeth were enrolled as individual subjects, Zelta’s intuitive interface facilitated the coordination of multiple sessions per participant while maintaining accurate records of each entry.
Moreover, the platform’s adaptability meant that any changes or updates to the trial protocol could be quickly integrated without causing significant disruptions. This feature was particularly beneficial in the context of dental trials where variables might change frequently, necessitating rapid adjustments to the trial design. The real-time data correction capabilities of Zelta further enhanced the quality of the data collected, ensuring that any inaccuracies could be promptly and effectively addressed, leading to cleaner, more reliable datasets.
Success Metrics and Future Potential
Randomization in clinical trials is critical for minimizing selection bias among participants and ensuring robust, reliable results. To address these challenges, Solventum, a renowned medical device company, has transformed this crucial process through their adoption of the Zelta eClinical platform by Merative. This platform introduces an innovative approach to randomization that has caught significant attention within the industry. In a recent comprehensive webinar hosted by Krista Dahling, Supervisor of Clinical Data Management at Solventum, the company shared their groundbreaking experiences and strategies. During the session, Dahling elaborated on how their unique methods have markedly enhanced efficiency and minimized bias in clinical trials. This new approach not only supports more reliable outcomes but also contributes to the advancement of clinical research practices. By implementing these modern techniques, Solventum continues to set new industry standards for conducting clinical trials with precision and fairness, demonstrating the impactful role of technology in medical research.