Phase I and Phase III Trial Supplemental Instructions by iij26547


									                              Vanderbilt University Institutional Review Board
                  Phase I and Phase I/II Trial Supplemental Instructions

The IRB must be able to make a determination of whether a study has therapeutic intent.

 For the institution therapeutic intent has been defined as follows: *A trial has therapeutic intent
when the clinical trial protocol provides for the discovery, measurement, or verification of an effect of an
investigational intervention on a participant with a diagnosed disease to determine whether the
investigational intervention potentially improves health outcomes for the participant. The trial must not
be designed exclusively to test toxicity or disease pathophysiology. (Note: Studies involving only healthy
volunteers would not qualify, as no improved health outcomes are expected for healthy volunteers.)

In order to document the process and facts by which the determination for therapeutic intent was made
the points below should be considered. The protocol should reflect these points. The location of this
information from the protocol should be provided. The information is requested in order to assist the IRB
in assessing the therapeutic intent of the study.

     1. Participants have a baseline assessment for the status of the disease being studied.

     2. Participants have monitoring for the status of the disease being studied.

     3. Participants will discontinue taking part in research and or study interventions in the event there
          is disease progression.

If information addressing the above can not specifically be cited in the protocol the determination of
therapeutic intent cannot be made. If you have questions about this determination or need assistance
please contact the IRB at 2-2918 and ask for the Research Cost Analyst.

The following are points that may need consideration when developing a protocol in Phase I and Phase
I/II trials. (Please note addressing these points in the protocol does not mean that a determination of therapeutic intent will be

         Has the patient/participant exhausted all therapeutic avenues for their disease and still made the
          decision to pursue investigational drug treatment rather than to forgo treatment and receive
          palliative care?
         Is there a reasonable expectation of patient/participant benefit? It has been reported that
          response rates on Phase I studies range from 4.4-27.4% (E Horstmann et al: NEJM 2005;
         Is the study intended solely to evaluate toxicity, tolerability and pharmacokinetics? For instance,
          an example may be when the agent is administered only once without follow up of disease
         Do the scientific goals of the study take precedence over the patient’s best interests?
         In the case of oncology trials is stabilization of the tumor considered a response?

Help in developing a protocol can be obtained from the IRB website under                                            templates:

Phase I and Phase I/II Supplemental Instructions               1 of 1
Form revision date: October 22, 2009
Replaces Form dated: April 9, 2009

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