Phase IV clinical trials, Phase 4

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...

The cost of running a comparative effectiveness trial is $13,087 per patient during Phase IV, according to our newest Medical Affairs and Market Access research. Comparative Effectiveness Research (CER) compares drugs, devices or other medical tests and procedures...

We recently identified a drop-off in the role investigator initiated studies (IIS) play in companies’ pre-registration clinical development strategy. In a new report on investigator studies, analysts discovered a diminished share of Phase IIIa trials performed...