Management of Highly Publicized and Controversial Study

Infectious Disease Study

Management of Highly Publicized and Controversial Study

SPONSOR

A small spinoff from a global biotechnology company. The leadership team had a great deal of scientific and public health experience. Size of company at startup, six individuals.

PROJECT

A Phase 3 Preventative HIV vaccine study. The first preventative HIV vaccine study to move into Phase 3. Goal was to rapidly enroll over 5000 subjects globally and follow them for five years. The Sponsor gave ProTrials the task of starting up and completely managing this trial through close-out and analysis.

CHALLENGE

How do you successfully manage a controversial large-scale project from the ground up through the entire operational life-cycle? ProTrials effectively partnered with the sponsor during the early stages of the product’s clinical development (Phase 2) and supported it for eight years through Phase 3 analysis. With the eyes of the public health world on this groundbreaking study, ProTrials participated in every aspect from study design, implementation, project management, subject recruitment activities, monitoring, and the development of critical subject retention strategies. We were able to appropriately staff the project with experienced and flexible staff to ensure that goals and milestones were met. ProTrials used exceptional communication skills and effective tools to adeptly handle the complexities of frequent press activities and highly public community relations associated with this study.

RESULTS

Though the product failed to show efficacy, this project set the gold standard for trials in this area of prevention. The study model has been successfully utilized on several subsequent products. ProTrials continues to be dedicated to the prevention of infectious diseases.