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


Consider Expected Attendance to Determine Investigator Meeting Budgets

Victoria Cavicchi, pharmaceutical social media researcher
By Victoria Cavicchi,
Research Analyst

Determining clinical investigator meeting budgets is a key component of meeting planning. To determine the meeting budget, companies typically evaluate the number of attendees, reimbursed items and the cost of reimbursed items per attendee. To build more accurate investigator meeting budgets, companies must be able to identify their expected costs during the planning phase. Continue reading


Evolving Medical Information Team Abilities to Collect Unsolicited Requests More Efficiently

Victoria Cavicchi, pharmaceutical social media researcher
By Victoria Cavicchi,
Research Analyst

Thanks to evolving technology, medical information teams must also update their methods for receiving and answering unsolicited inquiries.  Medical communications teams have already begun looking to web portals and other Internet-enabled request modalities, as well as considering how to best monitor social media.  However, teams should also adjust their communications with field forces such as medical science liaisons (MSLs). 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


Following Finalization of EMA Guidance, Clinical Data Transparency Continues to Surge

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

Clinical data transparency continues to reflect a growing theme across the life sciences industry.  Over the years, many life sciences organizations, including Janssen and Novartis, have established initiatives allowing physicians and other scientific researchers to access clinical research findings through online portals.   Regulatory agencies in the US and Europe alike have also worked to expand existing public access to clinical trial outcomes. Continue reading


Pharmaceutical Call Centers: Agents on the Frontlines of Physician Communication

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior Research Analyst

When frontline communication with doctors comes to mind, many life sciences companies will turn to the commercial side of their organization.  After all, pharma sales reps are the ones touching base with physicians and presenting the product to them. But within their medical information groups companies should also look to pharmaceutical call centers for another perspective on how doctors are approaching and using their products. Continue reading


Pilot New Medical Science Liaison Programs with Contract MSLs

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

Life sciences companies point to the outsourcing of MSLs as a way for field-based medical teams to pilot new programs and activities while avoiding the risks of taking on fulltime headcount.  Whether the activity is HEOR, managed care, or whether it is testing a hybrid medical science liaison position, it is fairly simple to contract one or two experienced MSLs to pilot it out in the field, see how it goes, and then learn the results. Continue reading


Medical Information Leaders Justifying Resource Increases with Increased Responsibilities

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

Just like virtually every other function within pharmaceutical organizations, medical information teams must make strong cases to increase — and often simply justify — budget and personnel resources.  For many medical information leaders, one avenue to justifying their resources is an expansion of their teams’ duties beyond the primary duty of answering inquiries placed by internal and external clients. 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