Clinical trials have been leading the way for medicine and pharma companies in advancing novel drugs and treatments. But the success of the trials is heavily dependent on efficient data collection and management. Ever since the life sciences industry, like every industry in the world, embraced technological innovations, electronic data capture (EDC) systems have been playing a pivotal role in data acquisition.
But this is where the challenges emerge too. Accommodating mid-study changes (MSCs) is probably the most significant of the EDC challenges. Let us delve into the complexities of MSCs, their impact on clinical trials, and why is there a need for enhanced flexibility within EDC systems.
Mid-study changes are the alterations that are made to the study protocol or study data management plans (SDMPs) during a clinical trial. These modifications can arise due to a variety of factors including:
Regardless of the reasons behind mid-study changes, it is imperative that EDC systems become more adaptable to accommodate them effectively. MSCs present a substantial challenge to clinical trial timelines, with an average of 3 to 4 changes occurring in each study. The downside of these planned and unplanned MSCs is that they will result in extension of the trial duration by up to 30 days, impacting the trial’s cost and overall success.
Planned mid-study changes are amendments that are premeditated and strategically incorporated into the study protocol. These changes are designed to address specific issues, enhance the study’s quality, or respond to emerging insights and opportunities. They are carefully considered and part of the overall trial strategy.
Unplanned mid-study changes are the modifications made during the trial due to unexpected issues. These issues can include safety concerns, data anomalies, unforeseen circumstances, or any other factors that were not initially foreseen when designing the study protocol. Unplanned MSCs are often reactive measures to mitigate risks or rectify unexpected challenges.
A survey revealed that 79.7% of respondents expressed satisfaction with their EDC system’s capability to handle planned mid-study updates. This suggests that when changes are anticipated and integrated into the study design, most EDC systems are effective in managing them. The same survey reports that only 67.2% of respondents reported satisfaction with their EDC platforms’ ability to adapt to and effectively manage unplanned modifications.
The healthcare industry is witnessing a growing demand for clinical trials. With the acceleration of medical and pharmaceutical research, the need for adaptive and accommodating EDC systems has become more critical than ever. The ability to address both planned and unplanned mid-study changes swiftly and efficiently is vital to ensure that clinical trials run smoothly and deliver reliable data.
The impact of mid-study changes on clinical data management is multifaceted. Here are some of the key repercussions:
The need for EDC systems that can effectively manage mid-study changes is evident. The life sciences industry is evolving rapidly, with new technologies and regulatory requirements continually emerging. To meet these challenges, EDC systems must evolve as well.
Mid-study changes are an inherent part of clinical trials as they are important to improve study outcomes, address emerging issues, and ensure patient safety. However, effective management is essential to prevent delays, data quality issues, and budget overflows.
As the demand for clinical trials continues to grow, the life sciences organizations must embrace more flexible and adaptive EDC systems for optimum study results. These systems can empower researchers to address mid-study changes proactively, ultimately contributing to the success of trials and the advancement of medical science.
IQA’s InductiveEDC (IEDC) is one such tool to efficiently handle mid-study changes. Built to be adaptable and flexible, IEDC can accommodate MSCs, planned or unplanned, without hassle. The AI capabilities infused within the platform help sponsors and CROs in not just reducing dependency on paper-based processes to capture data but also accelerate the trials.
Make the right choice to efficiently handle MSCs with IEDC. Reach out to us at hello@inductivequotient.com to demo the tool and learn more.
