Patient and Stakeholder Engagement

Premier Insight 252: A Novel Treatment That Worked So Well It Almost Derailed the Study

We were testing an autologous chondrocyte transplantation system to repair damaged knee cartilage. The problem was that patients felt great after treatment, and saw no need to make follow-up visits.

But the FDA required us to track results for seven years.

The challenge: To keep patients involved for seven long years, especially active young patients who moved away from their original locations.

The unexpected skills that made the difference

Of course, understanding the science was key. The procedure offered unique challenges; there had been no advances in treatment in 13 years. This medical device study involved performing a biopsy, growing the patient’s cartilage for 21 days, and re-implanting it to replace defective cartilage.     

But that was only the beginning of the complex issues we faced. Patients were generally healthy, so we had to develop an advertising campaign to spread word of the study. We have done it often, and successfully, with two goals: to attract the proper patient population and to give the trial a polished, professional appearance that made it attractive to clinical sites. The investigators we needed were used to performing surgeries and sending patients back to their primary care physicians, so we had to win their enthusiasm for performing frequent and long-term follow-up visits – something they were not at all used to. In addition, the patients were young and fundamentally healthy – especially after a successful surgery. Yet for the study to be a success, we had to keep them involved for seven years of follow-up. Seven years!

Solution: we stopped acting like a CRO, and did what the patients do

We jumped into social media in a big way. We friended them. We found texting to patients’ smart phones to be an especially effective way to stay in touch. There were many things we had to do that aren’t what a CRO normally does. But then, that’s what we do best: adapt to whatever unexpected challenges the project presents.