By Kristina Lopienski, Product Marketing Manager, Forte Research Systems, Inc.
In today’s Clinical Operations Optimization track, a panel discussion titled, “New Approaches to Speeding Up Clinical Trials - What Works and What Doesn’t” was a great challenge/solution session. Craig Coffman of Nektar Therapeutics, the moderator, started the session by emphasizing that running a trial according to original timelines is hard work. Most trials operate in catch up mode, so rather than being ahead of the curve, they’re just trying to stay on the curve. It’s very easy to fall behind, and very difficult to make up any time that’s been lost.
This presentation featured three speakers who gave examples of what they’ve implemented with the goal of saving time on clinical trials.
Making it more convenient for the patient
Charles Drucker of Quest Diagnostics gave an example of a trial that used a phlebotomist service for blood draws. These storefront centers were quick and convenient for the patient and could save the trial time and money. Of course, this method works better for some therapeutic areas than others and isn’t a one size fits every study.
Visiting sites to show sponsor support
Manny Lazaro of Forum Pharmaceuticals talked about taking the time to actually visit and engage with the site (not at the investigator meeting). He’s traveled as far as Serbia to provide support and show that as the sponsor, they care about the site and want to be involved, even when the trial is outsourced to a CRO. Does showing up in person really work? These visits almost always lead to increased site engagement and show an immediate upswing in activities (e.g., 10%-15% boost in recruitment), though they eventually tend to level out again. The sponsors in the room all agreed it’s worth the resources that are required to support site engagement.
The group even talked about sponsors holding “rejuvenation meetings” in which they bring together sites (both underperformers and high enrollers) to learn from each other and have them take time to pause and reflect on what’s gone right, as well as discuss any problems they’re having with getting patients in and consented. Sites appreciate this approach, as opposed to what they’re used to hearing, “When are the patients coming?” over and over again.
Setting goals and committing to bold experiments
Terri Roberson of Abbvie engaged the room with an experiment her company did, called “40 sites in 40 days” which took place between Thanksgiving and Christmas last year. The goal of this challenge was to enroll 40 sites and have them up within 40 days. Having previously taken 90 days on average to get a site up, this was a lofty goal. To save time, they did all feasibilities over phone and offered no contract negotiations. It was a “take it or leave it” offer, where the sponsor was saying we’re committed to you, you need to let us know if you’re committed to us.
The results? All 40 sites were up within 40 days, and they enrolled 100% faster than the non-experiment group of sites. Terri explained how internally they had to get a lot of people behind this effort, which ended up being a lot of work, but a huge accomplishment that really worked for them.
Craig challenged the room not to try just one of these examples, but try a combination of all three, yet recognizing that every situation is different and there’s no one silver bullet to speeding up clinical trials. One of the greatest realizations of this session was that the example methods presented weren’t due to any great new technologies – they were process improvements.
About the Author: Kristina Lopienski is the Product Marketing Manager for Overture EDC at Forte Research Systems. In her role, she works to bring educational resources to clinical research professionals. She writes on a variety of topics affecting clinical trials on the Forte Clinical Research Blog. Kristina is currently the guest blogger covering Partnerships in Clinical Trials 2015.