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March 31, 2008
Investigator-Initiated Trials Get Centralized
For a long time, drug companies supported IITs with varying levels of oversight. To some degree, that has changed. Many of the industry's leading companies have made efforts to centralize IIT management at the therapeutic area level or higher. A recent survey, shows that three-quarters of companies employ a dedicated IIT group to handle tasks such as proposal collection and evaluation, funding, ongoing study oversight and post-study data usage. Previous data set this level at 50%, so it's clear that large companies are formalizing their IIT management.
Centralization empowers companies to better select the most strategically and scientifically interesting IITs, track those studies' progress and employ their findings in constructive ways. Most organizations still find themselves a great distance from this ideal, however. Interviewed executives reveal that many organizations still suffer from a lack of knowledge regarding the number of IITs underway, investigator identities, funding levels and, last but not least, the progress of these trials and planned uses for their findings.
Gaps in management may yield undesirable outcomes, such as IIT results that conflict with company-sponsored research, investigators competing with a company for patients and sub-par handling of adverse events and safety reporting. In worst-case scenarios, study results get published without project or brand teams ever being aware that their drugs were the subjects of outside research. To counter these issues, every survey respondent reported a need to improve IIT management. Additionally, companies face real or perceived staffing shortages in functions that contribute to the IIT process.
Centralized IIT strategy setting and process management are only out of their infancy stages. The vast majority of IIT groups must still establish SOPs, confront ongoing challenges, refine their structures and win internal respect and support for their missions.
Posted by Eric Bolesh at 02:42 PM | Comments (0)