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MORE Ancillary Studies Policies and Procedures

An ancillary study is defined as one that involves participants in the trial and requires procedures or measurements that are not included in the protocol for the main trial. All plans for ancillary studies must be approved the Steering Committee. Proposals for ancillary studies are initially reviewed by the Publications and Ancillary Studies Committee and then approved by the Steering Committee.

Ancillary Studies Committee (also the Publications Committee)

This committee will be composed of investigators participating in the trial, investigators from Lilly and one or two scientists not affiliated with the trial. This committee is charged with developing policies and procedures for ancillary studies and for reviewing and making recommendations about the scientific merit of ancillary studies to the Steering Committee.

Policies and procedures

Approval by the Steering or Ancillary Studies Committee does not imply that financial support will be provided by the company or that time for data analysis time will be provided. Arrangement for these resources must be made independently.

We encourage investigators to conduct ancillary studies within their own centers, or in cooperation with other centers with the stipulation that such studies be scientifically sound and do not have negative impacts on the main trial.

An investigator who wishes to conduct an ancillary study must submit a formal proposal. There must be at least one principal investigator included among the investigators of any ancillary study. The proposal, generally 3-5 pages in length, should include the following elements:

  1. research question with clearly stated hypothesis
  2. background and rationale for the study
  3. the methods and procedures to be employed
  4. the sample size required to answer the research question (including the assumptions underlying these estimates)
  5. a detailed estimate of the impact of the study on the main trial (e.g. staff and participant time; radiation exposure)

The completed application should be submitted to the chair of the Committee, c/o MORE Project Assistant by email (see MORE directory) or by mail to UCSF MORE Coordinating Center, 74 New Montgomery Street, Suite 600, San Francisco, CA 94105 USA.

The Committee will review each application, considering its scientific merit, quality of the design and methods, and potential impact on the main trial. The Committee may ask for revisions before voting on approval. The Committee members must be allowed at least 10 working days to review the proposal. Failure of Committee members to respond will be regarded as approval of the proposal. If there is no consensus about approval, the investigator may be asked to revise and resubmit, or the Committee may be convened by conference call (with the investigator) to consider and vote on the proposal, or the Committee may refer the matter to the Steering Committee for consideration.

If the study is approved by the Ancillary Studies Committee, it will be submitted to the Steering Committee (usually by mail) for final action. The Steering Committee members will have 10 working days to respond. If no member votes to disapprove, then the proposal will be approved. If any member votes to disapprove the proposal, then chair of the Steering Committee will request written reasons for the disapproval and a written response from the investigator. The chair may convene a conference call to discuss the proposal and will request a formal vote of the Committee. A response favoring approval from a majority of the members will be required for approval.

Note that all ancillary studies must eventually be approved by the appropriate institutional review boards before they are performed, but IRB approval is not required to submit a proposal to the Ancillary Studies committee and is not essential for approval by that committee.

If substantial changes in the design of the protocol or in the potential impact of the protocol on the main trial occur after Steering Committee approval, then the investigators must submit the revised protocol to the Ancillary Studies Committee for review and approval.