Other Services

How OR Can Help

Protocol design is the most difficult aspect of clinical research, and inadequate design is the major reason studies fail. Often these failures could have been prevented by simple protocol modifications. Outcomes Research thus provides complementary review of investigator-initiated clinical research protocols. In consultation with the investigator, members of the Department of Outcomes Research will identify potential strengths weakness of proposed studies. We will then suggest protocol modifications that can strengthen the study. In almost all cases, we can suggest modifications that are inexpensive and easy to implement, but nonetheless substantially improve proposed projects.

A major goal of Outcomes Research is facilitating research. We thus support investigators and help with investigator-initiated projects. Assistance is provided by experienced faculty, with the goal of turning rough ideas into workable studies.

At the initial meeting, we will evaluate proposed projects and make an evaluation of how to proceed. Possibilities include recommending that the project be abandoned, help transforming the proposed study into one with a stronger design, or a recommendation to continue with the original plan. Nearly always, we recommend continuing the project, but make suggestions that strengthen the design.

We are pleased to offer the following services:

Protocol design review

  • Assistance with grant applications
  • Sample-size estimation
  • Preparation of IRB applications and communication with the Committee
  • Preparation of case-report forms
  • Data management, including design and programming of custom databases
  • Statistical analysis
  • Assistance with manuscript preparation


Investigators are free to select the services they wish, ranging from assistance with every aspect of a study to help with statistical analysis of a completed project.