My journey from participating in a trial, to supporting them.
You really understand what "Patient-centric" means when you have been a participant in a clinical trial. My family and I have participated in many clinical trials. Two types of trials have stood out for us. There are the ones where all the staff, on the phone in a telemedicine visit, on-line, or in person really seemed to know what they were doing! They could answer your questions promptly and get you through the process efficiently. The others are those where the staff seemed confused or not sure of what to do next. These were the trials that made it hard to trust the system or continue in the trial regardless of whether it was a bricks-and-mortar or a decentralized trial.
So how do we help all site staff stand out for the right reasons?
If we all could learn everything from reading it, there would be no teachers, only books. So, reading a protocol is not sufficient.
If we could retain everything we crammed into our heads, then attending a 1-2 hour "death-by-PowerPoint" session would work. But we don't; and it doesn't.
People need to learn at their own pace, with opportunities for practice. By focusing on the high-risk topics, we assure that the key areas are covered and understood.
By breaking down our lessons into small chunks that cover one concept, learners can learn in short bursts at their own convenience and pace. In addition, a chunk of learning can be used to increase repetition by redeploying key content as microlearning, a useful way to retain understanding of, and engagement in, a complicated protocol over time.
Staff who understand a trial will enroll the right patients and conduct the right procedures, as they are comfortable with the complexities and will be able to convey that confidence with the patients they encounter, whether at a brick-and mortar site or by telemedicine means. They stand out for the right reasons!
Margaret leads curriculum design and medical writing at ScienceMedia, and she has experience in research, teaching and instructional design, and industry practice. She conducted research at Sandoz Agro and in Pharmacology at UT Southwestern Medical Center, the Green Center for Reproductive Biology Sciences, and the Howard Hughes Medical Institute. Margaret has extensive teaching experience in General Biology, Molecular and Cell Biology, Physiology and Endocrinology, and was awarded the Distinguished Teaching Award at UCLA. Margaret has a Ph.D. in Biology with an emphasis on Molecular Endocrinology from UCLA.
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.
