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 a sponsor 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 a sponsor’s 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 a sponsor 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, double-blind study in asthma. We have also provided data management, statistical analysis and reporting services for an open-label Phase 4 trial in asthma, and have completed numerous post-hoc exploratory statistical analyses with primary responsibility for development of journal articles and abstracts.
- 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.
- We completed comprehensive planning and handled all elements of execution related to data management of a large, multi-center, multinational, post-marketing trial in a neurological indication.
- Core members of the PROMETRIKA team have led three Phase 4 head-to-head comparative studies of drugs indicated for asthma, acute exacerbation of chronic bronchitis (AECB), and allergic conjunctivitis. Their participation in these studies began during the protocol design phase, and continued through data management, statistical analysis, and medical writing. Two of these studies (asthma and AECB) resulted in publications in peer-reviewed journals that were co-authored by one or more members of the PROMETRIKA team.
- PROMETRIKA staff was also involved in the protocol development of two additional Phase 4 studies. One study was designed to evaluate the effects of a nasal steroid for the treatment of allergic rhinitis on the growth velocity of prepubescent children. A second study was designed to compare the efficacy and safety of two drugs in the treatment of allergic conjunctivitis. Our statisticians played leadership roles in planning these studies and in developing strategies to facilitate several unique design features.
- PROMETRIKA’s Senior Director of Clinical Operations and Data Management, Faith Haines Kolb, led the largest national osteoporosis risk assessment registry, a major undertaking designed to assess the interrelationships of risk factors to support improvements in health education. The study involved 205,000 subjects across 5,000 sites.
- PROMETRIKA team members have developed abstracts, posters and full presentations used to present findings at many of the most influential and prestigious professional meetings around the world. Dr. Miganush Stepanians, PROMETRIKA President & CEO, presented results of a meta-analysis that demonstrated the efficacy of a treatment for allergic conjunctivitis at the American Academy of Asthma, Allergy, and Immunology annual meeting. She has provided consulting services and co-authored several articles for peer-review journals related to Phase 4 clinical research.
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.