Phase IV clinical trials, Phase 4

Finding patients in a very specific disease state is difficult enough, but in the shadow of Phase III, it’s nearly impossible.  In fact, next to Phase IV, Phase III patient enrollment looks easy.  Phase IV patient recruiters are stuck competing not only with...

Phase 4 clinical trials not only serve to gather valuable data surrounding drugs’ safety, tolerability and real-time effectiveness, but also to test potential new indications, develop stronger marketing profiles, gain payers’ favor and prove superiority over...

By David Richardson, Research Team Leader Post-marketing research is a growth area. An ever more cautious and stringent regulatory environment, payers that require more and more data to justify formulary approval and reimbursement, and more crowded...

By Ryan McGuire, Senior Research Analyst Pharmaceutical companies are growing more strategic in their investigator initiated trial (IIT) selection. As Research and Development organizations have sharpened their focus on mission-critical pre-approval...

Clinical development outsourcing budgets have steadily risen since 2008, but Phase II outsourcing has grown at a faster rate than any other phase, according to our recent clinical development study. Patient recruitment, complex setup requirements, and the need...

Our recent study of Phase IV Trials found that post-marketing studies are increasingly "regionalized" to better meet U.S. and European market requirements. Differences in what regulators and payers are looking for in post-approval information in Europe and...

By David Richardson,Research Team Leader Within pharmaceutical companies that manage Phase 4 trials through their Clinical Development organizational structure, Phase 4 clinical programs must compete directly with the company's own pre-launch clinical...

Regulatory pressure, more demanding payers and stiffer competition push overall Phase IV growth Our recent Phase IV clinical research report finds that Phase IV work is growing rapidly, meaning expanding budgets for post-marketing research studies. And more...

Global average across the pharmaceutical and biotechnology industries now almost $6,000 per patient The Research team's new study found that drug companies spend an average $5,856 per patient to fund a Phase IV clinical trial in the United States. The project...

Phase IV trials serve an increasingly important role in the commercialization of pharmaceutical products. They serve a range of purposes, from augmenting safety, tolerability and real-time effectiveness data and identifying potential new indications to developing...