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

Establish and perfect internal controls to capitalize on IIT opportunities

Investigator-initiated clinical trials (IITs) provide companies with the clinical data to further scientific understanding of their drugs. IIT findings help to expand on- and off-label usage, reach new patient populations, generate data for publication and solidify relationships with key opinion leaders. Once considered an afterthought, IITs are now often regarded as critical pieces of product development strategy.

Reflecting this different mindset, many companies have established centralized IIT management groups and processes. While such efforts mark a giant step forward, all organizations still routinely confront challenges that range from slowdowns in the IIT-approval process to issues with trial oversight.

Investigator-Initiated Trials addresses such obstacles and provides solutions by outlining steps to refine IIT management efforts. Use this report to accomplish the following goals:

- Develop strategic thinking to align IITs with corporate strategy

- Compare timelines and best practices for IIT proposal evaluation and approval

- Improve ongoing IIT oversight

- Discover IIT management trends

- Benchmark structures and investments

- Examine profiles of 16 companies' IIT efforts

Companies Included in Report

Abbott Laboratories

Allergan

AstraZeneca

Bayer Schering

Biogen Idec

Bristol-Myers Squibb

Celgene

Eisai

Eli Lilly

Genentech

GlaxoSmithKline

MedImmune

Merck & Co.

Novartis

Pfizer

Roche

Sanofi-Aventis

Solvay

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]

Published 2008

169 pages

400+ Metrics

100+ Charts and Diagrams

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