Investigator-Initiated Trial Management

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This report is a guide to accelerating and improving investigator-initiated trial management. First, track investigator-initiated trial performance metrics and approval timelines to gauge efficiency — and learn which stages should be expedited. Then, understand how to evaluate IIT submissions and negotiate contracts more efficiently, and navigate compliance concerns regarding budgets and documentation. Benchmark investigator-initiated trial spending and internal management costs to build the perfect budget. Finally, use real-world examples to establish investigator-initiated trial management structures that facilitate fast approvals and submission tracking

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Report Details

Publication Date: February 2015
Pages: 253
Chapters: 4
Metrics: 500+
Charts/Graphics: 213
Number of Surveys/Companies: 30+

Top Reasons to Buy This Investigator-Initiated Trial Management Report

Evaluate investigator-initiated trial submissions and negotiate contracts more efficiently: Delays reduce — or can even eliminate — IIT value, postpone or negate company research goals, expend resources and frustrate investigators. Learn proven strategies, such as pre-screening proposals, for expediting investigator-initiated trial evaluation, and consult six key criteria for selecting the right IITs. Performance metrics, including the number of proposals received, evaluated and approved, are also vital in accurately assessing investigator-initiated trial management efficiency. Examine timelines showing the number of days spent on nine investigator-initiated trial stages. Teams must track the time they are spending to know which stages can be shortened. These data will allow for more detailed planning — saving time and money down the road. Teams surveyed for this report also identify negotiating contracts as a top challenge. Benchmarking data indicate that establishing clear and consistent responsibilities, such as using legal teams to help with contracts, can significantly accelerate the process.

Establish investigator-initiated trial management structures that facilitate fast approval and submission tracking: Structure plays a key role in ensuring efficient investigator-initiated trial management. Involving local and global-level personnel during investigator-initiated trial approval processes, for example, helps to avoid duplication of efforts. Examine case study examples comparing different approaches to investigator-initiated trial team structures, as well as the investigator-initiated trial management support coming from other internal groups. As teams strive to accelerate investigator-initiated trial decision making, having efficient IIT proposal reviews is crucial. Creating standard operating procedures (SOPs) is one key step. Another important aspect involves IIT review committees. Data in the report explore IIT committee structures and which functions retain voting privileges during proposal evaluation.

Benchmark investigator-initiated trial spending and internal management costs to build the perfect budget: Examine benchmarks, best practices and case studies to build a solid IIT budget. Key metrics include the percentage of investigator-initiated trial budget dedicated at the beginning of each year, sources of IIT funding, percentage of budget spent on external spending and IIT internal management, average funding per IIT and IIT funding compared to the number of approvals. Along with providing overall team budgets, surveyed investigator-initiated trial managers were asked to elaborate on one recently completed study. Because life science companies can offer support for IITs in a variety of ways, this report examines which line items are company-funded and which items are left to the investigators. Benchmarks include budget line items for specific pass-through costs, direct costs and indirect costs. The report includes 12 full-budget profiles of recently completed trials.

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Excerpt from Investigator Initiated Trial Management

As the number of investigator-initiated trial (IIT) submissions increases, existing IIT management challenges magnify. The final outcome of an IIT is out of a pharma company’s hands, so it is essential for teams to properly vet each proposal. Otherwise, companies risk putting their products — and the resulting data — into poorly designed studies with inexperienced or unqualified investigators. To avoid problems down the road, successful teams approve IIT proposals that demonstrate scientific merit and align with shifting corporate objectives. Structure plays a key role in ensuring efficient IIT management. IIT structures that facilitate communication across global and local teams align company goals with IIT strategies and approvals.

Performance metrics provide another avenue for teams to boost IIT efficiency. Teams can track the number of submissions they receive, evaluate and approve. Another key metric is the time it takes an IIT team to move a submission through the stages of IIT approval and contract negotiations. Besides providing a productivity lift, performance metrics enable IIT teams to further demonstrate their value to the company.