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Investigator-Initiated Trials:
Building Superior IIT Capabilities (PH114)

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Published 2008
169 pages
400+ Metrics
100+ Charts and Diagrams

  Overview

Companies Metrics Content

Call Oveda Slade at 919-403-6583 to learn more about investigator-initiated trial (IIT) management departments, processes, and strategy.
 
Sample Content

(The following is excerpted from Chapter 2, "Overview of the IIT Selection Process." The full report contains additional details regarding the processes by which companies collect, screen, review and approve IIT proposals.)

Establish and Adhere to a Firm Set of Selection Criteria
Virtually all of the surveyed companies use some form of a standardized evaluation method to systematically identify viable proposals and reject infeasible ones. The criteria that review teams use to filter through study proposals are often based upon corporate strategic goals that are established by IIT management, as discussed in Chapter 1.

Although selection criteria vary from one company to another, the foremost qualities that companies seek include:

  • Strategic alignment: will the study help to accomplish the company’s strategic objectives?
  • Scientific merit: how valid is the study hypothesis?
  • Originality: is the study concept a novel one?
  • Feasibility: how achievable are the study’s specific aims?

Surveyed companies agree that strategic goals should play a role in the IIT selection process but recognize that translating those goals into a concrete set of standards is difficult. Some companies have made their selection criteria more specific in an effort to better match them with corporate strategies. An executive at Company F notes, “Worldwide we have put a more standardized infrastructure in place than we had a couple of years ago and added more detail and description to our SOP. We are putting more controls in place to make sure that the correct criteria are being compiled to ensure [strategic alignment].”

Hold Frequent Review Meetings to Streamline the Evaluation Process
Survey results speak loud and clear: the more frequently formal review committees meet, the more efficient they are at approving IIT proposals. Companies that hold weekly meetings achieve the most efficient process time of 11 days, on average, as Figure 2.13 [data charts appear in full report] illustrates. The relationship between meeting frequency and approval time is direct — companies that hold biweekly meetings achieve more efficient evaluation times than those that hold monthly meetings, and so on.

Despite the apparent benefits of meeting weekly, 57% of examined companies hold monthly, rather than weekly or biweekly, review committee meetings to evaluate IIT candidates, as seen in Figure 2.14 [data charts appear in full report]…

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