SOURCE: Cutting Edge Information

Cutting Edge Information

October 11, 2016 09:08 ET

Pharma to Clinical Investigators: Reach Target Patient Enrollment or You Don't Get Paid

87% of pharmaceutical companies refuse to provide payments to investigators unless they achieve patient enrollment goals

RESEARCH TRIANGLE PARK, NC--(Marketwired - October 11, 2016) - A study published by Cutting Edge Information found that 87% of surveyed pharmaceutical companies would not submit next-level clinical payments to investigators unless they achieved target patient enrollment.

The milestone payments in question relate to investigator initiated trials (IITs), where clinicians independently sponsor clinical studies and receive compensation to complete the trial. The data further show that 70% of teams relied on earning IRB approval or other regulatory actions as a key milestone for remitting investigator payments. Only 30% of surveyed firms wait to pay investigators until the final approval of the detailed IIT proposal.

According to the report, Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practice, 61% of teams require investigators to have enrolled his or her first patient before providing the next large clinical payment. Other milestones used for IIT teams include submission of interim study report and submission of manuscript for publication. While each pharma firm reported using different milestones, no company claimed to not use any milestone payments for IITs.

"Companies pay clinical investigators based on the level of work they perform," said Natalie DeMasi, research team leader at Cutting Edge Information. "If companies have to terminate studies early because investigators are unable to recruit sufficient numbers of patients, they will prorate the work and request that additional funds be returned."

Milestones payments are typically separate from the routine clinical trial updates that many drug companies already require. These milestones serve a dual purpose of ensuring that trials stay on track and that companies remain prudent as they fund IIT trials.

Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices is a complete guide of IIT best practices. The report, available at http://www.cuttingedgeinfo.com/research/medical-affairs/investigator-initiated-trials/, provides benchmarks and best-in-class tactics for managing investigator-initiated trial programs. This report delves into each of these stages:

  • IIT proposal selection
  • Resources
  • Performance metrics
  • Compliance

The report also serves as a guide to improving IIT management. It contains best practices and benchmarks for efficient and rigorous IIT evaluation. Backed by quantitative and qualitative research, this study examines dedicated teams' roles and responsibilities. The report's highlights and metrics include:

  • Structural and staffing recommendations regarding companies' dedicated IIT management teams.
  • Strategic, step-by-step analyses of IIT progression: from submission to first patient enrolled, including best practices for speeding up associated timelines.
  • An enhanced look at IIT budgets from average overall costs to specific expenditures.

For more information about Cutting Edge Information's IIT benchmarking products and services, please visit www.CuttingEdgeInformation.com.

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