It’s About Time: Clinical Trial Visit Simulations
April 5, 2017 | Norman Goldfarb calls himself a “refugee from high tech.” When the tech bubble burst in 2000, he found himself in the company of a doctor who wanted to start a clinical research site, and so they did. For about two years, they built up the site, but with excellent study coordinators, there wasn’t much for him to do, so he started writing about clinical research and speaking at conferences.
Compared to his previous life in high tech, Goldfarb really likes clinical research. “We think we’re pushing paper around, but, really, we’re saving lives. And the people are very friendly… Nurses tend to be friendlier than software programmers.”
Goldfarb believes that clinical research coordinators are at the center of the action. “People from sponsors and CROs and everyone else should spend a day at a clinical research site shadowing a study coordinator… They’ll be shocked at how they spend their time.”
Now Goldfarb is Editor of the Journal of Clinical Research Best Practices and Chairman of MAGI. His passion is advancing the practice of clinical research by standardizing best practices in incremental steps, so every day is better than the last.
Goldfarb joins Clinical Informatics News with a column highlighting new ideas for advancing clinical research. In his inaugural column, Goldfarb speaks with Faye O’Brien, PMP, Programme Director, Global Medicines Development at AstraZeneca.
But it would only be fair to first turn the mic to himself. So, Norm, what do you think it’s about time for in clinical research?
“Allison, the clinical research enterprise is very project focused. As a result, we’ve tended to focus on short-term relationships. After a study ends, the sponsor says goodbye to the sites. The sites say goodbye to the study participants. Then we basically start all over again with the next project. It’s about time we focus more on building long term relationships. The good news is that it’s starting to happen.”
--Allison Proffitt, Editor, Clinical Informatics News
Norm Goldfarb: Faye, what do you think it’s about time for the clinical research enterprise to start doing?
Faye O’Brien: Norm, study sponsors need to start simulating clinical trial visits to better understand the patient and site experience. We’ve conducted what we believe is the first use of mock clinical trial visits to predict patient sentiments during the actual clinical trial. With these insights, we adjusted the protocol and related operational details to optimize the patient and site experience.
Can you tell me more about these simulations?
Sure. Two research centers simulated the informed consent visit, the screening visit, and a dosing visit with 18 patients per draft Phase 2 and 3 protocols for systemic lupus erythematosus (SLE)/Lupus Nephritis (LN). We then conducted semi-structured interviews with the patients and site staff.
What did you learn?
We learned a lot. For example, patients want to know how their SLE experience compares to that of others. Many patients don’t really understand the commitment they are making when they join the study. Our planned visits were too long. And our study would be competing with other studies that would be easier for the study coordinators. The simulations generated over 60 recommendations.
Given the time and cost to conduct these simulations, when do they make sense?
Good question. It depends on the study. Sponsors should ask themselves the following questions, among others:
- Does the sponsor have experience with similar studies and, if so, how did they go?
- Has anything changed—like standard of care—since any previous studies?
- Does the sponsor anticipate any particular challenges in enrolling and retaining study participants, with good adherence?
- How well does the sponsor understand the patients’ point of view?
- Does the sponsor have any particular concerns about the complexity, feasibility or practical aspects of the study?
Well, Faye, this makes a lot of sense to me. I hope to hear more about your progress in the future.
Norman M. Goldfarb is Editor of the Journal of Clinical Research Best Practices and Chairman of MAGI. Contact him at 1.650.465.0119 or email@example.com.