A Clinical Research Coordinator's Plea to Embrace Innovative Site Staff & Participant Training to Elevate Clinical Trials
Authors: Ivy Tou, E-Learning Designer at ScienceMedia, and Claire Dennis, Marketing Coordinator at ScienceMedia.
When it comes to clinical trials, staff and study participant training can be challenging, to say the least. With 90% of clinical trials failing1 and reported errors commonly sprouting from lack of site staff training and frequent confusion around trial protocols2, effective training is vital to a successful trial. Small to large sites and sponsors lose millions on trial failures3 , yet site staff are often expected to sit through lengthy in-person investigator meetings (IMs) and site initiation visits (SIVs), or worse, they're asked to flip through printed materials in order to fully retain their trial protocols. This outdated approach is inefficient and fails to meet the needs of today's learners. In contrast, young students in elementary schools are participating in modern e-learning with digital, online lessons—why hasn't the pharma industry embraced more modern training methods?
To shed light on the frontline experiences and insights of clinical research professionals, we sat down with former Clinical Research Coordinator and Research Lead, Ivy Tou, currently an E-Learning Designer at ScienceMedia, a company providing clinical trial training solutions. Tou shares her personal perspective on the persistent challenges around staff and participant training in the industry, and advocates for sites and sponsors to embrace more effective, innovative educational solutions. She emphasizes that implementing modern, learner-centric training approaches is crucial for improving protocol compliance, lowering trial timelines and costs, reducing confusion, and ultimately, getting drugs to market faster for those who need them. She also points out that leveraging technologies and techniques that engage and empower site staff and participants can help the industry drive meaningful progress in this long-standing area of challenge. Tou states:
Having previously worked as a clinical researcher, I have firsthand experience with the challenges in the clinical research industry, particularly regarding patient literacy, staff training, and communication. One of the biggest issues I encountered was the lack of adequate training provided by pharmaceutical companies. When conducting research projects, my team and I were often given only an IRB protocol manual and expected to learn the entire research process within a single day—without structured guidance or proper onboarding. This lack of training led to inefficiencies, confusion, and ultimately impacted the quality of patient interactions and data collection. Had we had access to the educational resources offered by ScienceMedia, it would have significantly improved our ability to understand and implement research protocols effectively.
Now, as a designer at ScienceMedia, I see the critical role our content plays in bridging this gap. My background allows me to empathize with both the challenges faced by clinical research staff and the complexities involved in developing effective educational solutions. I understand how difficult it can be to work with pharmaceutical and research organizations that are often resistant to change and hesitant to adopt new training methods. Many of these companies operate within rigid structures and may not immediately recognize the value of integrating ScienceMedia's solutions into their workflows. However, from both a research and design perspective, I see the tangible benefits our content can provide in improving training and patient outcomes.
As an E-Learning Designer at ScienceMedia, Tou sees the powerful aid of innovative training platforms like SMi TrialTM and SMi EngageTM, site staff and study participant training solutions provided by her current company. She hopes that others in the industry will move away from rigid clinical trial training structures to improve protocol compliance, data quality, trial costs, and patient retention.
About ScienceMedia
At the vanguard of clinical trial efficiency and training innovation, ScienceMedia is revolutionizing the industry by shortening trial timelines by up to 20%, accelerating site activations and enrollment, and saving millions in R&D spend per trial. Our SMi SourceTM, SMi TrialTM, and SMi EngageTM solutions are transforming therapeutic area training, clinical study operations, and clinical trial participation for biopharma, medtech, and CROs. Learn more at www.sciencemedia.com.
1 Sun D, et al. Acta Pharm Sin B. 2022.
2 Andrianov, A. Cyntegrity. 2014.
3 McKenzie H. BioSpace. 2024.
Media Contact:
Claire Dennis
Marketing Coordinator
ScienceMedia, Inc.
619-339-0065
support@sciencemedia.com
When it comes to clinical trials, staff and study participant training can be challenging, to say the least. With 90% of clinical trials failing and reported errors commonly sprouting from lack of site staff training and frequent confusion around trial protocols2, effective training is vital to a successful trial.
The Trump administration's recent executive orders targeting Diversity, Equity, and Inclusion (DEI) programs have sparked concerns about their potential impact on the Food and Drug Administration's (FDA) efforts to implement the Diversity Action Plan (DAP) requirement for clinical trials.
This all comes down to understanding the specific needs of that specific community, and none of us are the same. It's not always a one-size-fits-all. - Jocelyn Ashford on defining success in promoting health equity in clinical trials
The ultimate measure of success to me would be that we no longer need to focus specifically on this idea of diversity. It should automatically be embedded in everything that we do. - Jocelyn Ashford on defining success in promoting health equity in 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.
