June 15, 2017 | Norman 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. He joins Clinical Informatics News with a monthly column highlighting new ideas for advancing clinical research. This month he speaks with Reg Blynn, Vice President of Client Services at QuintilesIMS.

Reg, what do you think it’s about time for the clinical research enterprise to start doing?

Norm, it’s about time more clinical sites stop being reactive and start being proactive. I really noticed this during my 10 years on the site side of the business. There are 3 areas in which sites could be more proactive: business development, patient recruitment, and quality.

What should they do to be proactive in business development?

Sites should be cultivating long-term relationships with major CROs and sponsors, so they see new studies first. They should be looking for studies six to 18 months out. If a site is asking for business now, what message do you think that sends the sponsors and CROs?

What can a site do to be proactive in patient recruitment?

Even before a study is awarded, the site should start screening patients and even talk to some of them about the study, in general terms. With that information, the site will really know whether it can do the study and can negotiate the budget on that basis. And then, when it looks like the study is going to happen, the site can get a head start on recruiting. These are the sites that generate those massive enrollment numbers in the first couple of weeks.

Study sponsors want rapid patient recruitment, of course, but they also want quality data. How can sites be proactive about that?

That’s what internal quality management systems are for. Sites should stop relying on the sponsor’s monitors as the first line of defense for quality control. That can’t be good for your reputation. If a site can’t afford even one internal quality monitor, at least it can schedule weekly peer-to-peer reviews, where the coordinators check each other’s work. No matter what the system, quality requires a clear commitment from management to protect it from all the other priorities.

Reg, this makes perfect sense, so why isn't proactivity commonplace already?

Well Norm, it is commonplace for the sites that are growing, the best-in-class sites, and the top networks. Reactivity is in the past, proactivity is 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 ngoldfarb@firstclinical.com.