'Investigator-Initiated Trials: Building Superior IIT Capabilities' Outlines Steps...

'Investigator-Initiated Trials: Building Superior IIT Capabilities' Outlines Steps to Refine IIT Management Efforts

DUBLIN, Ireland--(Business Wire)--
Research and Markets
(http://www.researchandmarkets.com/reports/c87932) has announced the
addition of Investigator-Initiated Trials: Building Superior IIT
Capabilities to their offering.

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

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)...

For more information visit
http://www.researchandmarkets.com/reports/c87932

Source: Cutting Edge Information

Research and Markets
Laura Wood, Senior Manager
Fax: +353 1 4100 980
press@researchandmarkets.com

Copyright Business Wire 2008