Investigator Sponsored Trials: Structuring Evaluation and Approval Committees

Natalie DeMasi, clinical development and medical affairs researcher
By Natalie DeMasi,
Research Analyst

There are many key elements to running a successful investigator sponsored trials (ISTs) program, such as:

  • Evaluating IST proposals efficiently
  • Only approving ISTs that have high scientific merit and align with corporate research objectives
  • Maintaining compliance with fair market value (FMV) and milestone payments

The investigator sponsored trials evaluation committee is at the heart of many of these processes.  A company’s IST team runs the program, but the IST committee is responsible for evaluating the submissions. Continue reading

Three Steps for Calculating FMV Investigator Compensation

Natalie DeMasi, FMV investigator compensation researcher
By Natalie DeMasi,
Research Analyst

In recent years, regulatory policies dictate that life sciences companies must pay physicians fair-market value (FMV) payments.  But, regulatory guidelines offer no rule book for how to calculate FMV.  This situation — however dire it may seem — actually offers companies a tabula rasa for establishing the best methods for FMV calculations.  While pharma continues to build its own guidelines for FMV, there are three broad steps for determining FMV investigator compensation: Continue reading

Mitigating the Risks of CER Clinical Trials

Natalie DeMasi, clinical trial and comparative effectiveness researcher
By Natalie DeMasi,
Research Analyst

One of the best ways to prove a product’s worth is to quash a competing product in comparative effectiveness research (CER) clinical trials.  Conversely, one of the best ways to harm a product’s market success is to be crushed in a comparator trial.  Of course, most CER clinical trials are not this definitive, but there are always risks of unexpected negative revelations.  Despite this, many life sciences companies look to comparative effectiveness findings to aid market access and commercialization efforts. 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

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

Dedicated Resources for Investigator Initiated Trial Management are Critical

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 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