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 patterns. Patients may also exhibit negative symptoms like those typically associated with depression; things like lack of pleasure in everyday life and lessened emotional range. The World Health Organization estimates that schizophrenia affects up to 24 million individuals globally. In the US, an estimated 1% of the adult population — 2.4 million — have schizophrenia. Continue reading


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 their competitors’ large-scale Phase III trials, but also with their own company’s later-stage studies. Continue reading


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 competitors’ products. While many phase 4 trials are conducted at the requirement of regulatory agencies, many are conducted simply to help boost products’ profiles. Needless to say, these trials can be particularly pertinent to the success, or failure, of a product regardless of the reason. Continue reading



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 clinical development studies, external investigators have become a critical channel to answer post-marketing product profile questions. But even as clinical resources concentrate on earlier phase work, IIT proposals do not organize, review, approve and manage themselves. Continue reading


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 for global coordination point to a continuation of outsourcing trends. The study, “Clinical Operations: Benchmarking Per-Patient Trial Costs, Staffing and Adaptive Design,” found that on average, companies outsourced Continue reading


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 the United States seem to be driving greater regional variations in the types of Phase IV clinical trials that pharmaceutical and biotech companies emphasize. Post-marketing studies offer Continue reading


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 programs for patients, resources and vendors. Unfortunately for those relying on Phase 4 data, clinical development teams generally place the majority of their focus on pre-launch registration trials that regulatory agencies require for drug approval. For this reason Continue reading


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 of that work is being done by third parties and specialized vendors. “Phase IV Clinical Trials: Best Practices in Post-Marketing Study Management” found that registries and observational studies spend the highest percentage, on average, of their budget on outsourcing – 60 percent. The next highest Continue reading


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 spanned several types of Phase IV studies, including investigator initiated trials, registries and observational trials and large simple safety trials. Continue reading