Phase IV clinical trials, Phase 4

7.23.2013 Lifecycle Management

From Phase 3 to Post-Marketing Studies: The Journey of Aripiprazole IM (Abilify Maintena)

By Sarah Ray, Research Analyst Schizophrenia is a complex psychological disease state that distorts patients’ cognitive and emotional responses. Patients may experience positive symptoms such as delusions, hallucinations or disorganized thought...
 

1.23.2013 Clinical Development

Phase IV Patients Are a Virtue

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...
 

7.26.2012 Medical Affairs

Accelerating Phase 4 Clinical Trials a Matter of Improving Enrollment

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...
 

4.26.2012 Medical Affairs

More Companies Integrating Planning and Execution of Phase 4 Clinical Trials Under Medical Affairs

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...
 

3.16.2012 IIT Studies

Investigator Initiated Trial Management Earns the Dedicated Resources It Deserves

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...
 

12.5.2011 Clinical Development

Outsourcing of Phase II Drug Development Now Accounts for 63% of R&D Budgets

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...
 

11.29.2011 Medical Affairs

Phase IV Trials Becoming Regionalized by Differences in Regulatory Environments and Payer Demands

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...
 

11.2.2011 Medical Affairs

Phase 4 Trials Conducted within Clinical Development often Face Stiff Internal Competition

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...
 

10.7.2011 Medical Affairs

Phase IV Clinical Trials Outsourcing Up

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...
 

9.22.2011 Medical Affairs

U.S. Phase IV Budgets Top $12,000 Per Patient

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...