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Products & Services Medical Affairs Clinical Trials

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

ID: 5708


Features:

8 Info Graphics

21 Data Graphics

250+ Metrics

10 Narratives


Pages/Slides: 40


Published: 2021


Delivery Format: Online PDF Document


 

License Options:


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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER
Non-members: Click here to review a complimentary excerpt from “Best Practices in the Management of Investigator Initiated Trials in Oncology: Structure, Activities and Responsibilities”

STUDY OVERVIEW

Manufacturers of oncology products often support investigator-initiated trials (IITs) to explore novel opportunities to address unmet medical needs. However, as organizations increase the number of IIT trials, it is important for companies to properly vet each proposal and approve the ones that demonstrate scientific merit and align best with corporate objectives.

Best Practices, LLC conducted this benchmarking research to provide a detailed roadmap for improving IIT management within oncology companies, capturing critical metrics and insights on IIT management team structure, activities, responsibilities, leadership, SOPs, proposal evaluation and review process.

KEY TOPICS

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

KEY METRICS
  • 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

SAMPLE KEY FINDINGS
  • 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.

METHODOLOGY


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.


Industries Profiled:
Medical Device; Pharmaceutical; Manufacturing; Biotech; Consumer Products; Diagnostic; Health Care; Biopharmaceutical; Clinical Research; Laboratories


Companies Profiled:
Becton Dickinson; Bayer; Cipla; Daiichi Sankyo; Eisai; EMD Serono; Guerbet; Ipsen; Jazz Pharmaceuticals; Karyopharm Therapeutics; Merck; Sandoz; Sanofi; Solidfarma; Takeda Pharmaceuticals

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.