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U.S. Department of Health and Human Services

About FDA

Improving the Efficiency of Clinical Trials

Description: Support multiple projects to make clinical trials more efficient - Examples include develop, plan, and hold training for clinical investigators worldwide to improve the safety and efficiency of clinical trials; support Clinical Trials Transformation Initiative (CTTI) project to draft and issue white papers (part of large effort to improve trial management and protect the safety of participants while optimizing procedures to ensure trial quality and data acquisition).

Accomplishment: To address the clinical trial industry's chronic shortage of well-trained, experienced clinical investigators committed to performing clinical trials over the long haul, the office has launched an annual 3-day Clinical Investigator Training Course targeting medical professionals. Clinical investigators are pivotal to medical product development because they provide FDA with the clinical data required for making regulatory decisions. This training course helps to develop a cadre of well-trained investigators by ensuring that they are apprised of FDA regulatory and monitoring requirements as well as other key knowledge areas essential to conducting quality clinical research. In the November 2010 course, senior FDA experts and guest lecturers from industry and academia offered participants from across the globe FDA perspectives on such important issues as new safety concerns, adverse event monitoring, compliance with legal and ethical obligations of clinical research, and acceptable scientific and analytic standards in clinical study design. Videos, slides, and transcripts are available to those investigators unable to attend the 2010 course on FDA's Critical Path Initiative website.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Issue white paper on goals and objectives of clinical trial monitoring

8/1/2010

Completed 5/17/2010

B. Announce FDA Clinical Investigator Training Course in the Federal Register

9/30/2010

Completed 9/21/2010

C. Hold Clinical Investigator Training Course

11/8/2010 - 11/10/2010

Completed 11/8/2010 - 11/10/2010

D. Expand training outreach by publishing video course online

3/31/2011

Completed 12/5/2010

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.