Bright Pharmaceutical Services was called upon to assist in accomplishing a patient recruitment and retention assignment for a 23-country clinical trial. The recruitment goal was to randomize a total of 550 subjects utilizing 65 global site locations. The study included a 16-month enrollment period.

Goal:
To evaluate the safety and efficacy of a new lupus nephritis medication in conjunction with Mycophenolate Mofetil (MMF) and corticosteroids.

Overall Study Design and Plan
This was a Phase 2, randomized, 12-month double-blind, placebo-controlled study designed to evaluate the safety and efficacy of the compound compared to placebo in the treatment of subjects with active lupus nephritis.

Educational and Support Materials

Bright provided study branding and graphic design services aimed at supporting both the site staff and the patients who participated in the trial. Branded patient handbooks, cold pack medication carry bags, backpacks, lupus books and books on tape, relaxation CD and sun protection (as stress and sun exposure are triggers for a flare up), physician slide deck and educational materials for Lunch and Learns, posters and study flyers, mini-protocols, pocket size inclusion-exclusion criteria cards, visit reminder postcards, recruitment postcards, thank you cards, presentation invitations and follow up cards.

All materials were translated into 21 languages and developed with global study participation in mind. Fulfillments services were provided by Bright’s internal team.

Outcome:
Site enrollment completed on schedule across all counties. Enrollment increased markedly with the use of branded study materials and enrollment ticked up globally when the materials were distributed. When polled, participants expressed that the support materials helped them throughout the trial and that they appreciated receiving education about their disease in addition to participating in the trial.