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. My role as a medical writer on the SMi Trial team is to transform that information into multimedia videos that educate investigators and study staff on how to avoid the key risks for protocol deviations. As the number of decentralized trials has increased over the last year, I have helped to adapt our innovative approach to protocol education with the creation of SMi TrialD.
My clinical background as an M.D. lends me insight into the challenges investigators face to ensure the reliability of data collection and monitor patient safety as they implement the virtual components of decentralized trials. I can relate to the hesitancy of providers to adopt telemedicine and know first-hand the learning curve involved with using the various new mobile healthcare technologies. I also understand that the reliance on bringing your own device technology has shifted a lot of responsibility onto patients to follow the specific timelines and activities required by study protocols.
With all the changes involved with decentralized trials, educating all stakeholders is imperative to their success. It's been my rewarding job at ScienceMedia to create impactful, easy-to-understand educational videos to help investigators, study staff, and patients understand how to safely and effectively participate in decentralized clinical trials.
Dr. Steve Nair brings his clinical expertise and passion for medical education to help create educational tools that teach complex science topics simply. Dr. Nair has worked as a medical writer and product manager for four years at ScienceMedia. Prior to joining the team, he had experience researching across multiple therapeutic areas, including cardiology, oncology, and neuroscience. Dr. Nair received his M.D. from Wayne State University School of Medicine and trained in internal medicine at UC San Diego.
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.
