Evaluating potential technological barriers among participants can help to improve study outcomes
As a previous Clinical Research Coordinator, I understand the importance of meeting recruitment goals; however, I also understand the importance of evaluating whether someone is the right fit for a study. Decentralized clinical trials offer great value and inclusivity, as people can participate in a clinical trial from the comfort of their own homes. The adoption of telemedicine for decentralized trials has served as an advantage for enrollment efforts since it provides convenience for patients. Although virtual clinical trials may provide convenience, they also come with unique challenges. In decentralized trials, patients are commonly expected to record data through online systems, electronic devices, or mobile healthcare devices. Depending on the demographic of a study, evaluating the level of familiarity or accessibility a patient has with technology is a critical step. Technological barriers may inadvertently impact remote monitoring efforts and promote challenges for patients. Since decentralized trials are remote, they should be modeled with a patient-centric approach to compensate for the absence of in-person patient interactions.
Every clinical trial has the potential of facing challenging complexities, which is why proper protocol implementation is critical. At ScienceMedia, we work to reduce the occurrence of barriers, difficulties, and efficacy challenges for clinical trials. While every clinical trial may be vulnerable to complex barriers, proper training procedures can greatly reduce the occurrence of challenges. As a clinical writer, I work to identify key risks for a study and tailor training materials specific to the needs of a study. Here at ScienceMedia we strive to create a strong foundation for trials in an effort to improve efficacy outcomes.
Monica holds a Bachelor of Science in Public Health from San Jose State and is passionate about public health promotion. As a clinical writer and previous Clinical Research Coordinator, Monica combines her passion for public health promotion and experience to optimize the benefits of SMi TrialD. Monica's goal is to support and contribute to the efficacy efforts of SMi TrialD by implementing risk mitigation strategies for clinical trials.
For moviegoers, Morpheus' line, "Unfortunately, no one can be told what the Matrix is. You have to see it for yourself," followed by an offering of a red or blue pill to Neo, brings us right to the scene in the mega blockbuster hit, The Matrix.
As we reflect on this past year, let's close out 2023 by acknowledging the great strides pharma has made. Who's on board for some levity? If you are, read on.
Clinical trials are a crucial part of the medical research process for all patient communities. These trials help researchers determine the safety and effectiveness of new treatments and drugs, as well as identify potential side effects and other factors that may affect patients' health and wellbeing. However, conducting clinical trials for rare diseases comes with a unique set of challenges that can make the process more difficult and complex than trials for more common diseases.
The clinical research community is continually called to modernize its approach to clinical trials. More recently, this push is attributed to the passing of the Food and Drug Omnibus Reform Act (FDORA), intended to reshape clinical trial design and operations.
ScienceMedia and Halloran Consulting Group (Halloran) recently collaborated during a Halloran-hosted CORE Retreat - a Clinical Operations Retreat for Executives - in the Boston area. The connection between these companies is simple. They understand the proven need to provide results-driven and multi-media format training to sponsors operating clinical trials across all phases of the study.
Halloran Consulting Group launched CORE East over two decades ago - a Clinical Operations Retreat for Executives - which is an invitation-only meeting that brings together an exclusive group of senior leaders in clinical development to discuss and debate the most pressing issues around the business of product development and building enduring life science companies.
To use a sports analogy, protocol deviations and violations in a clinical study represent unforced errors. The application of proper study training, like that delivered through SMi TrialTM, ScienceMedia's Protocol Compliance Management platform, has been proven to reduce and eliminate these entirely avoidable mistakes.
Decentralized Clinical Trials (DCTs), and their near cousins that apply a hybrid approach of in-person and remote visits, are increasingly seen as a viable solution for the conduct of clinical trials.
Facilitating the human connection in decentralized clinical trials
Evaluating potential technological barriers among participants can help to improve study outcomes
My journey from participating in a trial, to supporting them.
Over the last four years at ScienceMedia, I have worked with dozens of study teams to understand the unique operational complexities of their clinical trials.
