Looking for IIT Performance Metrics? Try the Percentage of Evaluated Proposals that the Committee Approves

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

Like all sub-functions in medical affairs, investigator-initiated trial (IIT) teams are being pressured to provide upper management with performance metrics to demonstrate team value.  The underlying purpose of these metrics is to show team activity, efficiency and success.  Useful IIT performance metrics include the number of submissions received and approved, the number of resulting publications and the length of time it took the evaluation committee to approve a proposal and negotiate the clinical trial agreement (CTA) with the vendor. Continue reading


Investigator Initiated Studies: Composing Cross-Functional Evaluation Committees

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

Approving investigator initiated studies (IIS) is a multi-step process that can be both time-consuming and complicated.  Once an investigator submits an IIS proposal, one pivotal step is for the team’s evaluation committee to assess the proposal for scientific merit, alignment with corporate strategies and investigator credentials – as well as budget and compliance aspects. Continue reading


Get Your Compliance Ducks in a Row By Evaluating IIT Research Grants for FMV

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

Like any medical affairs subfunction, compliance is a major concern for investigator initiated trial (IIT) teams.  Companies have no say in an IIT’s protocol, patient recruitment practices or final publication, so teams need to get all their compliance ducks in a row before giving out an IIT research grant.  One of the most crucial compliance concerns is that the IIT’s proposed budget is fair-market value (FMV). Continue reading


Top 3 Criteria for Selecting Investigator Initiated Trials to Fund: Strategy Alignment, Scientific Merit and Strong Investigator Credentials

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

There are many different names for investigator sponsored trials (ISTs), such as investigator initiated trials (IITs), investigator sponsored studies (ISS), investigator initiated research (IIR) and a number of other variants of those titles that you can think of.  IITs – or whatever sobriquet you prefer – vary in budget, patient population, phase and research goals even more than they vary in name.  But one thing does not change about investigator sponsored trials: the need to carefully select which trials are worth funding and which ones are not. Continue reading


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