I recently caught up with my longtime friend and colleague, Norman Goldfarb. Norm is well-known to all of us in the clinical trials industry as an innovator and a best-practice thought leader for fostering clinical trial site relationships with sponsors and CROs.
Norm’s resume is impressive: he is managing director of San Francisco-based Elimar Systems, which is building a technology platform to help improve efficiency, speed, and compliance in the clinical trials industry; he heads two organizations pushing for progress in trials (more about that below); for 17 years he was editor of the Journal of Clinical Research Best Practices; and for 18 years, he was chairman of Model Agreements & Guidelines International (MAGI), which works to standardize best practices for clinical research operations, business, and regulatory compliance.
I’m always fascinated to hear Norm’s observations and learn about his latest activities. Here’s a look at the industry initiatives and future opportunities we discussed.
The Site Council: Fostering Healthy Clinical Trial Site Relationships
Norm is executive director of The Site Council, an industry collaboration now in its second year. The council is made up of about 2,400 clinical sites and site networks with the goal of eradicating problems sites have with sponsors and CROs and vice versa.
The group created The Site Council Dream. This document lists the priorities that sites have when working with sponsors and CROs. These priorities include:
- Providing essential information
- Allowing professional autonomy
- Providing fair and timely compensation
- Proficient governance
- Patient centricity support
- Allowing a collaborative relationship
Member clinical trial sites encourage study sponsors and CROs to review the document and adhere to the listed priorities when working with them. Norm said sponsors/CROs can determine which areas they have already addressed, which require simple policy changes, and which they can work on in good faith over time. “These problems are granular, actionable, and measurable. So, they can actually keep track of whether they’re doing a good job or not,” Norm said. There are no membership fees or paperwork, just a common voice and goodwill.
To benefit from this initiative, sites must conduct studies in a safe, ethical, efficient, high-quality, and timely manner. “Every sponsor wants to be a sponsor of choice, and every CRO wants to be a CRO of choice,” Norm said. “This is their checklist.”
Integrate Clinical Research Sites During the Planning Process
I couldn’t agree more with Norm’s sentiments and the need to bring a voice and guidelines to create great site-sponsor and site-CRO relationships. At Imperial, we have always stressed the importance of site buy-in to the clinical trial planning process. Sites are on the front lines and often have firsthand knowledge of what works and doesn’t work regarding patient engagement and day-to-day study conduct. Giving sites a seat at the table is paramount to successful study execution. As we say, get site buy-in early and often.
CRISI: Unifying Tech Tasks
Norm is also executive director of The Clinical Research Interoperability Standards Initiative (CRISI). This group has assembled a group of tech vendors to build a library of standard Application Programming Interfaces (APIs). When completed, this library will eliminate what Norm calls “the integration fire drills at the beginning of studies” and also remove the need for redundant data entry throughout the study.
“The average study coordinator spends a full day a week on redundant data entry. In what world does that make any sense?” Norm asked. “An objective is for sponsors to choose the apps they want, sites to choose the apps they want, and they just talk to each other.”
It’s been documented that study coordinators can have anywhere between 60 and 120 daily activities, depending on a variety of factors. So, Norm and CRISI are really onto something here in terms of utilizing technology to eliminate redundancies and drive efficiency. In fact, as long as I’ve known him, Norm has always directed his energies to create stronger clinical trial site relationships with sponsors and CROs, bringing down barriers to working together and finding ways to make the process more efficient. The Site Council and CRISI initiatives are very much in line with Norm’s tireless passion to create positive change.
Looking Ahead
I asked Norm about the key issues that are currently shaping the clinical trials industry and his predictions for the coming years. Norm told me he sees continuing consolidation of independent sites into site networks. How will this affect clinical trials? Norm expects site networks to streamline the clinical trial process and foster better working clinical trial site relationships with sponsors and CROs.
Viewing this development from the sponsor/CRO perspective, Norm predicted: “You’re going to have trusted relationships with a number of site networks. You’re going to pick the 10 best for that particular therapeutic area, and you’re going to call your buddies on the phone. And you say, ‘Here’s a new study we are doing, we already have a master clinical trials agreement, we already have a master rate card. Take a look at the protocol, I will email it to you now, and let’s get started on Friday.’”
Artificial Intelligence Will Change the World
Artificial intelligence (AI) seems to be popping up everywhere, and not surprisingly, Norm and I discussed this hot topic. “I have a lot of background in technology,” Norm said. “There’s a ton of new AI companies, and pretty much every established tech company has some AI projects.”
Norm said AI’s effect on trials is in its infant stage. “I don’t think we’ve even scratched the surface,” he told me. “There’s got to be at least a thousand places where AI can contribute to clinical research. It’s going to be a messy process finding out who does the best job on AI and making it all work, but that’s the way technology progresses. The world’s going to look very different in a few years.”
That certainly got my attention, and I’m eager to see what the clinical trial industry will look like in the coming years.
My interview with Norm is the latest addition to my ongoing Imperial Executive Interview Series. You can watch the full interview with Norm below.
