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

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.