The importance of patient experiences in clinical trials cannot be overstated. Patient participation fuels medical research advancement and plays a pivotal role in determining a sponsor’s Return on Investment (ROI). However, as we delve into this intricate web of patient engagement, recruitment, and retention, we uncover a critical question: Why do sponsors sometimes lean toward …
Generally a requirement in clinical research, electronic clinical outcomes assessments (eCOA) come with their own set of acronyms. Let’s dive into some of the most commonly used assessments, their significance, and the types of trials that can benefit the most from their implementation. Acronyms C-SSRS (Columbia-Suicide Severity Rating Scale) The C-SSRS is a validated tool …
The digital revolution has disrupted traditional norms in various sectors, leading to innovative approaches in both employment and healthcare. Remote work has gained immense popularity over the years. It’s empowered employees to work from the comfort of their homes. Likewise, the concept of decentralized clinical trials is transforming the landscape of patient participation in research …
This article shines a light on the fascinating journey of decentralized trials, their bumps in the road, how we can navigate these bumps, and the exciting possibilities ahead. By definition, decentralized trials are a new way to conduct medical research using technology to make things easier for the participants. They offer a new way to …
In today’s real-time, data-driven world, clinical trials are also reaping the benefits of this data influx. The increasing usage of integrated devices, like personal medical devices, and the integration of electronic Clinical Outcome Assessments (eCOA) with electronic Patient Reported Outcomes (ePRO) platforms have brought a wave of innovation and improvements. Medical Devices To begin, let’s …
We’re witnessing a paradigm shift. The trial landscape is changing rapidly, and a significant part of this transformation stems from an increased focus on the patient experience. A prime example of this shift is the innovative approach of Patient Journey Mapping, a tool that helps researchers to understand the patient’s path through the healthcare system. …
Sexual orientation and gender identity (SOGI) are important social determinants of health that can significantly impact health outcomes. However, historically, clinical trials have not adequately accounted for these factors. Thus leading to a lack of representation and exclusion of marginalized populations. This exclusion has resulted in health disparities that are often perpetuated by inadequate data …
Clinical trials are conducted around the world to evaluate the safety and efficacy of new drugs, devices, and treatments. These trials often involve participants from different linguistic and cultural backgrounds, making accurate translations essential for ensuring participant understanding and data quality. In particular, electronic patient-reported outcome (ePRO) and electronic clinical outcome assessment (eCOA) measures have …
Growing up, I always questioned why I’d be going with my grandmother to my great aunt’s house to administer medication, multiple times a day. What was this medicine doing? Why did she need it? It wasn’t until well into junior high, that I learned the significance of the medication that she was taking. And how …
The US Food and Drug Administration (FDA) has recently taken steps to promote the advancement of decentralized clinical trials (DCTs), recognizing the potential to improve patient access and participation. As the VP of Compliance at Datacubed Health, I would like to share our analysis of these developments and offer recommendations to sponsors, CROs, and sites …