Best Practices in the Management of Investigator Initiated Trials in Oncology: Structure, Activities and Responsibilities

• IIT Submission Review and Systems
• Functional Involvement
• Important Criteria for IIT Evaluation
• Key Reasons for Rejecting IIT Proposals

• Do you have a dedicated IIT management department?
• What types of IIT studies does your organization support?
• What is the involvement of various functions during concept review, IIT oversight, IIT operational management, and IIT publication review?
• What is the level of position of the IIT operational team lead?
• What is most challenging part of IIT structure & management?
• Do you have written SOPs for IIT processes?
• What functions are represented on the IIT committee?
• How frequently does the IIT review committee meet?
• What role do MSLs play in IIT management?
• At which stage, does your IIT committee allow the conversion of an IIT to a collaborative study?
• What percentage of total number of approved IIT submissions belong to each of the listed study types?
• What are the most important criteria when evaluating an IIT proposal?
• What are the reasons for automatically rejecting an IIT proposal?
• Top three approaches to increase the efficiency of oncology IIT review
• What are the components of the tools used to facilitate submission review?
• How do you review concept proposals on a rolling basis or within a submission window?
• Please rate the effectiveness of the metrics used to measure IIT performance

• Most IIT submissions occur in an online setting: Two-thirds of the surveyed oncology companies use tools like online portals, trackers and database tools to facilitate submission review.

For this research, Best Practices, LLC engaged 18 leaders from 15 oncology organizations through a benchmarking survey. More than three-fourths of the benchmark respondents serve at the director level or above.

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