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

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

83% of Investigator Initiated Trials Lead to Medical Publications

While sponsors maintain editorial distance from investigators’ findings, they increasingly push researchers to take action on publication

Published data from investigator-initiated trials (IIT) have proven extremely valuable for both scientific and commercial goals. While pharmaceutical companies do not have control over editorial content and the publication process, sponsors do see their IIT data published in peer-reviewed medical publications in 83 percent of trials, according to our new study, “Investigator Initiated Trial Management.” Researchers also found that drug companies are holding investigators more accountable Continue reading

Investigator Initiated Trials Increasingly Impacted by FMV Concerns

Investigator initiated trial (IIT) management teams must incorporate fair-market value (FMV) into their payment protocols to appropriately respond to regulatory scrutiny and maintain compliance. In our new study, “Investigator Initiated Trial Management,” 23 percent of study participants ranked oversight or intervention from the Office of Inspector General (OIG) as their number one IIT management challenge. Continue reading

Investigator Initiated Trial Budgets up 21%, Finds New Study

Blockbuster brands’ IIT spending booms with large companies topping $20 million

Pharmaceutical and biotech companies increased their investigator initiated trial (IIT) budgets by an average 21 percent this year, and they’re not stopping there. Our newest study, “Investigator Initiated Trial Management,” found that companies allocated an average $7.3 million to IIT budgets in their current budgets, but resource allocation varied widely between large drug manufacturers and other companies. The Top 25 companies’ IIT budgets average $21.5 million while all other companies’ budgets average Continue reading

Growth within growth: Investigator Initiated Trials rising as overall Phase IV studies surge

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 stronger marketing profiles, and proving superiority over competitors’ products. Among the types of Phase IV trials, investigator initiated trials (IITs) are the fastest growing, according to our two newest studies.

The first, Phase IV Clinical Trials: Best Practices in Post-Marketing Study Management, identifies IITs as the most frequently used type of post-marketing study conducted by surveyed companies. Continue reading