Clinical Investigator FMV: Differentiating Research-Driven Costs from Standard of Care Expenditures

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

For trial sponsors, building a budget that anticipates all potential study expenses is one of the more challenging aspects of clinical planning.  A recent Cutting Edge study — targeting clinical investigator FMV — found that clinical trial budgets cover a number of study expenditures.   Many of these trial costs are directly associated with site initialization and sites’ ongoing responsibilities: from enrolling study participants to managing patient retention. Continue reading


Supporting Investigator-Initiated Trials: Develop IIT Management Team Numbers In-Line with Centralization Practices

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

Investigator-initiated trials (IITs) are developed and executed under the direction of third-party clinical investigators.  However, life science teams often require ample in-house teams to support these activities from start to finish. Dedicated teams handle tasks such as managing online investigator portals and reviewing IIT submissions. Continue reading


Female Key Opinion Leaders Receive Smaller Percentage of Research Funding, Finds Recent Cleveland Clinic Study

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

Over the past few years, the industry has paid close attention to the Sunshine Act’s physician payment reporting requirements.  Ideally, publication of payment data will usher in a new era of transparency regarding how key opinion leaders (KOLs) interact with life science teams.  However, while many healthcare consumers may welcome Sunshine Act reporting, some physicians and industry groups remain apprehensive that consumers will take financial information out of context.  Moreover, previously released physician payment data already demonstrates that individuals may not always receive equivalent compensation for the same types of work. Continue reading


IIT Approval: The Stanley Cup of Investigator-Sponsored Research

Sarah Ray, regulatory affairs and safety researcher, avid hockey fan
By Sarah Ray,
Senior Research Analyst

Like NHL playoff teams vying for the Stanley Cup, investigators submitting IIT proposals are also competing with one another — and the competition is fierce.  In its Investigator-Initiated Trial Management study, Cutting Edge Information found that surveyed life sciences teams received an average of 108.7 IIT proposals in 2014.  Of these proposals, companies evaluated an average of 99.2 of combined concept and protocol submissions and approved an average of 43.5. Continue reading


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