The Need for Institutional Policies for Innovative Therapy: Existing Approaches and Key Elements.

Objectives: Innovative therapy is common in many areas of medicine. Yet, it is unknown whether medical centers have policies to ensure innovative therapy is conducted appropriately.

Design: We contacted three informants at leading U.S. medical centers to determine whether the center has a policy for innovative therapy and, if so, what requirements the policies include and whether the policies lack any important elements.

Setting: Existing policies and published recommendations.

Patients: None.

Interventions: None.

Measurements and main results: Our search found that 46 of 58 responding centers (79%) do not have a policy for innovative therapy. Of the ten policies available for review, half lack requirements to report patient outcomes, and half do not explicitly coordinate innovative therapy with research.

Conclusions: A majority of leading U.S. medical centers do not have a policy for innovative therapy. In addition, existing policies lack important elements, especially with respect to reporting patient outcomes and coordinating innovative therapy with research. Based on the existing policies and recommendations in the literature, we thus identify eight key elements that should be included in policies for innovative therapy. Future research should assess whether these elements can be feasibly implemented and whether, in practice, they offer patients appropriate protection.