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

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior 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

IIT Submissions Moving Online: Looking for a Better Process

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

David Richardson, pharmaceutical commercialization and launch expert
By David Richardson,
Director of Research

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

David Richardson, pharmaceutical commercialization and launch expert
By David Richardson,
Director of Research

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

Dedicated Resources for Investigator Initiated Trial Management are Critical

Ryan McGuire, lifecycle management tactics expert
By Ryan McGuire,
Research Team Leader

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 Increasing in 2012

Our current review of pharmaceutical and biotechnology strategy for the new year finds that 42 percent of companies will see investigator initiated trial budgets increasing in 2012. 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 Investigator Initiated Trial submission systems by large companies is primarily due Continue reading

Stiff Internal Competition for Phase 4 Trials Conducted within Clinical Development

David Richardson, pharmaceutical commercialization and launch expert
By David Richardson,
Director of Research

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