An ad hoc committee will plan and host a 1.5-day public workshop that will feature panel discussions and invited presentations. Workshop participants will explore the challenges in developing molecularly targeted therapies and the associated biomarker tests within the traditional research and development paradigm as well as the challenges in implementing treatments and biomarker tests in clinical practice. A major goal of the workshop will be to facilitate discussion about potential strategies and actions to address those challenges.

Participants will be invited to discuss topics that may include:

• clinical trial designs, the role of registries, and the "N-of-1" approach to evidence development;
• evidentiary needs, regulatory processes, and ethical/legal considerations;
• the logistics and funding of multisite studies, including patient participation and coverage of experimental costs (biospecimen acquisition, biomarker test and drug costs) in clinical research; and
• clinical decision-making tools for appropriate implementation in clinical practice.

The committee will develop the agenda for the workshop sessions, select and invite speakers and discussants, and moderate the discussions. An individually authored workshop summary will be prepared by a designated rapporteur based on the information gathered and the discussions held during the workshop in accordance with institutional policy and procedures.