December 26, 2017 | Earlier this year, Norm Goldfarb and I found a quiet spot at the SCOPE Summit to do some brainstorming. Goldfarb has been writing about clinical research and attending and speaking at conferences for the past fifteen years, relying on his experience starting a clinical research site and his previous life in high tech. 

And along the way he’s been listening: Listening to study coordinators. Listening to doctors. Listening to sponsors. Listening to CROs. Now, as Editor of the Journal of Clinical Research Best Practices and Chairman of MAGI, Goldfarb’s passion is advancing the practice of clinical research by standardizing best practices in incremental steps, so every day is better than the last.

After our brainstorming session, Goldfarb and I launched a new column for Clinical Informatics News, an opportunity to share the conversations he’s been having with the rest of the clinical-IT community.

Over the past few months, Goldfarb has shared candid conversations with representatives from sponsors, CROs, tool-providers, and regulatory oversight groups on the pain points in clinical research and what changes are needed. It’s good stuff; I hope you enjoy the opinions and insights captured here.

--Allison Proffitt, editor, Clinical Informatics News

Get Real About Quality Management

Lee Truax-Bellows, President & CEO of Norwich Clinical Research Associates, warned us that it’s time to stop paying lip service to using a Quality Management System (QMS) approach and start practicing it. “It’s time we get serious about a systems approach to quality,” Truax-Bellows said. “QMS requires a change in mind-set. You have to fight the temptation to go-go-go and worry about the details later. A lot of training is required, not just of sponsor and CRO personnel but also of site and vendor personnel. The shape of timelines and budgets needs to change. Expectations need to change. Metrics need to change. Everybody needs to understand that investing in quality pays.”

IRBs and the Culture of Conscience

Erica Heath, IRB Historian and Guru, pulled no punches: “We need to think long and hard about whether we should be doing things the right way—the culture of compliance—or going to the next step to doing the right things—the culture of conscience.” IRBs are in a tough spot, she said. If a consent form is wordy and long and confusing, but still checks all the regulatory boxes, should the IRB approve it? Or push for a more transparent form for the trial participants? Principle investigators get called on the carpet as well: when a patient needs a second consent visit to feel comfortable and informed, should the site absorb that cost? There are no shortcuts, Heath insists. Instead we need “more thinking and less mechanically following the rules.”

Rise of the Research Compliance Oversight Committee

Scott Lipkin, Managing Director at FTI Consulting, calls for a new definition for the IRB. We’ve strayed from the IRB’s essential function, Lipkin says, which is “to protect the rights, safety, and welfare of human research participants.” To give IRB space to focus on participant welfare, clinical research needs a separate research compliance oversight committee, made up of a compliance professional, the Human Research Protection Program Administrator, an IRB Chair, representation from the legal department, representation from the investigator community (i.e., a physician investigator, a department head, or a dean), and perhaps others. “Most IRBs correctly self-identify as the definitive protector and advocate of research participants,” Lipkin said. “They don’t want to give up any part of that responsibility. Nevertheless, an IRB should look at the RCOC as another ancillary committee… that supports the IRB’s mission.”

Quantifying Protocol Complexity

Protocol complexity is eating sites a live, says David Morin, Director of Research at Holston Medical Group; CEO of TRIKE; and developer of SiteOptex Software. “The problem is that, when the complexity of a protocol increases by, say, 10%, the impact on the research site is not just 10% — it increases exponentially.” Increasing protocol complexity make it more laborious to enroll fewer study participants. Morin recommends using a tool to measure protocol complexity and applying those findings to both enrollment targets and budgets. “Until sponsors, CROs, and sites understand this dynamic,” he says, “we’ll keep getting surprised by high workloads and long timelines.”

Championing Standards for Sites and Sponsors

Fear of change is keeping the clinical research industry from embracing standards, says Terry Stubbs, President & CEO of ActivMed Practices & Research. “The clinical research industry is changing fast, and the old way that can create dirty data isn’t acceptable anymore,” Stubbs says. “Money is time. Time is money. We can’t afford to waste either.” In particular, Stubbs argues for more sites to use and invest in building industry standards. Stubbs encourages sites to use industry standards—including a long resource list sites can use without involving sponsors; give feedback when necessary; and press study sponsors and CROs to adopt at least parts of them. “This year, our site has seen 45 different versions of contracts and budget templates,” she says. “What a waste of time!”

Big Pharma on a Clinical Trial Run

At AstraZenca, modeling and simulation is becoming a crucial part clinical trial planning. Faye O’Brien, PMP, Programme Director, Global Medicines Development at AstraZeneca, says the pharma has “conducted what we believe is the first use of mock clinical trial visits to predict patient sentiments during the actual clinical trial.” The simulations led to adjusted protocols and operational details to improve the experience of both the patient and site. Two sites acted out consent visits, screening visits, and dosing visits for a lupus trial. Afterward, all the participants—those in the role of patient and staff—were able to give feedback. “We learned a lot,” O’Brien says. “The simulations generated over 60 recommendations.” Making changes based on those recommendations makes the study more competitive.

Proactive Sites: Moving First to Build A Strong Pipeline

Reg Blynn, Vice President of Client Services at QuintilesIMS believes it’s time for sites to take the reins. “There are 3 areas in which sites could be more proactive,” he says, “business development, patient recruitment, and quality.” Blynn encourages sites to cultivate relationships with CROs to learn about upcoming studies as early as possible; pre-screen participants for an area of need to have an idea of enrollment options; and develop systems of internal monitoring, even if it’s regular peer review between coordinators. These are the best practices for “the sites that are growing, the best-in-class sites, and the top networks.”