Experience by Phase
Phase 4/Post-Marketing Experience
Clinical research programs that result in regulatory approval and advance to Phase 4 studies can vary widely in both complexity and approach. While Phase 4 studies are often streamlined, with minimal inclusion/exclusion criteria, limited study visits, and a focus on select key data points, in planning and execution they can present unique challenges that require special experience and perspective. Post-marketing research also often demands a constant focus on efficiency and maximum return on investment for sponsors.
PROMETRIKA has extensive experience in the planning and execution of post-marketing research and publication programs for both large and small pharmaceutical and biotechnology companies. In work supporting prominent global brands, we have served as preferred provider responsible for design of post-marketing studies, conduct of targeted statistical analyses, and medical writing. We have provided biostatistics, data management, and medical writing services to support marketing and publication strategies for several leading companies. Our expertise in Phase 4 research includes comparative head-to-head studies with equivalence or non-inferiority endpoints, registries, special safety studies to fulfill Phase 4 regulatory commitments, post-marketing surveillance and safety follow-up, observational marketing research, risk assessments, awareness building, and product marketing support. In these efforts we often work closely with a sponsor’s marketing and medical affairs teams.
Highlights from PROMETRIKA Phase 4/post marketing experience:
- For several sponsors marketing drugs to treat neurological diseases, PROMETRIKA has provided study design, protocol development, and statistical analysis for several Phase 4 studies. Our services have included post-hoc exploratory statistical analyses of data from several Phase 3 clinical trials, and biostatistics and medical writing services for two Phase 4 head-to-head patient preference and quality of life studies. Working with sponsors’ medical affairs and marketing teams, PROMETRIKA medical writers prepared multiple presentations and lecture materials to present results of Phase 4 clinical trials to varied audiences including company senior management and external key opinion leaders.
- For several sponsors working in the pulmonary field, PROMETRIKA has provided essential support in study design, data management and statistical services for a large, multi-center, Phase 4 studies in asthma. We have also provided data management, statistical analysis and reporting services for these trials and have completed numerous post-hoc exploratory statistical analyses with primary responsibility for development of journal articles and abstracts.
- For a sponsor marketing drugs for metabolic disease, PROMETRIKA has designed and developed the protocol and statistical analysis plans for two large post marketing trials including a higly complicated observational trial required by the FDA.
- For two Phase 4 oncology trials, we provided essential support in statistical analyses and medical writing.
- The PROMETRIKA team coordinated data management and statistical analyses of two post marketing trials for an anti-infective drug for use in special/vulnerable populations.
Experience in Cost-effectiveness Analyses
In addition to experience conducting statistical analyses of Phase 4 studies, the PROMETRIKA team also provides specialized expertise in pharmacoeconomics. Dr. Nicole LaVallee, Director, Biostatistics, at PROMETRIKA, has developed cost-effectiveness evaluations for detailed dossiers of several marketed products. For three drugs (indicated for AECB, allergic rhinitis, and allergic conjunctivitis), she developed cost-effectiveness analyses against competitive products; her findings were presented to leading managed healthcare organizations including one of the largest healthcare service contractors in the U.S. These submissions helped secure formulary coverage on numerous healthcare plans. Additional cost-effectiveness analyses were also performed to support internal strategies related to product pricing.
Click here to link to PROMETRIKA publications, abstracts and posters.