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


Looking for Better IIT Submissions? Try moving the process online.

As the old saying goes, “Good help is hard to find.” Well, sometimes the best option is to make it easier for the help to find you. Our research has shown that Investigator-Initiated Trial proposals are on the rise over the last three years — averaging 173.3 per company in 2011, up 23 percent from 141.2 in 2009. In talking with IIT executives, many of them experienced noticeable increases in IIT proposals when their online submission portals were up and running. 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


Four Guideposts to Improve Investigator-Initiated Trials Payment Processes for FMV Compliance


By David Richardson,
Research Team Leader

The Office of the Inspector General at Health and Human Services (OIG) has been highly focused recently on tracking and publicizing pharmaceutical companies’ payments to thought leader physicians and clinical investigators. A number of companies have found themselves under investigation, and some have had to enter into Corporate Integrity Agreements to ensure their practices are up to the scrutiny.

Teams that run investigator-initiated trials (IITs) can play a major part in avoiding (or passing) OIG scrutiny by focusing on improvements in three major areas: 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


Investigator Initiated Trial Budgets Set to Rise in 2012

Our current review of pharmaceutical and biotechnology strategy for the new year finds that 42 percent of companies will be increasing their budgets for investigator initiated trials. Companies fund investigator initiate trials (IITs) to support additional clinical testing of post-marketed products conducted by independent physicians, often on smaller patient populations than those required by regulatory agencies for drug approval. Continue reading


Internet-Based Investigator Initiated Trial Submission Systems Grow

Over Half of Drug Companies Now Use Electronic or Web-Based Tools for Managing Proposals

Electronic or web-based submission systems for investigator initiated trial (IIT) proposals are now in place at 58% of biopharmaceutical companies, and that number is expected to grow. Three-quarters of large, top 25 drug companies have electronic systems in place, compared to only 40% of the remaining top 50 companies. The early adoption of these online IIT submission systems by large companies is primarily due 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