Focus on the solutions, not the problem: Persistence for a new treatment against neuropathic pain

In a Phase IIa study of a treatment for peripheral neuropathic pain after certain surgeries, FGK managed 38 sites in 5 countries all over Europe and continuously analyzed the data gained under an adaptive study design.

Recruitment was completed after 51 months, with 162 participants screened and 106 subjects randomized. Although the recruitment period was longer than sponsor and investigators expected, FGK hardly changed the study team and worked continuously on the project together with the sponsor - from the initial planning to the study report.

The project was facing a patient population very difficult to recruit as there are no central contact points for such patients.

• FGK conducted a high-end feasibility with the intended patient population in Europe and identified  two additional countries with 6 sites in each, what additionally boosted the enrollment significantly.  
• The cooperation with patient recruitment services brought further patients in all participating countries, but the game changer was the close cooperation between project team and study sites. Through continuous motivation and support, the sites succeeded in meeting the recruitment goal.

The primary endpoint was based on patient diaries. As an additional difficulty, patients had to wash out their existing and sometimes strong pain medication, a high commitment for their participation and retention.

In addition, the global COVID pandemic interrupted the smooth start with forcing the sites into lock down right after the Investigator Meeting.

• Again, FGK maintained very close collaboration with trial sites to ensure compliance and minimize drop-out rates by planning suitable visit dates as well as providing ideas for continuing patient motivation

The close cooperation between FGK, sponsor, sites and members of the IDMC also contributed to the ongoing trust of sites and patients

It was clear from the beginning, that recruitment in this very difficult-to-recruit patient population would not be easy, but neither the sponsor, nor the investigators expected it to be so hard. There was always an open and constructive exchange at eye level on this topic. Corresponding change orders - due to the extension of the duration - were negotiated with a sense of proportionality and great mutual understanding.

Despite the long recruitment period of four years, there were hardly any personnel changes in the FGK team and the same PM who started the study also completed it. Rather, FGK has consistently responded very flexibly to the needs of the project and has always provided the required resources to ensure the project is optimally supported at any time.

And in the end, everyone in the team was really pleased with the positive study results.