party payors more likely, he added. Finally, he pointed out that biomarker-based trial designs will narrow down the population most likely to benefit and therefore reduce sample size and toxicity, and provide opportunities for enrollment in other trials.

CONCLUDING REMARKS

In final closing comments before adjourning the meeting, planning committee co-chairs Drs. Moses and Mendelsohn both commended the quality of the presentations and subsequent discussions. Dr. Mendelsohn remarked that a valuable outcome from the meeting was “educating each other in this room.” For example, “clearly there was tremendous cross communication between the people that are in [the molecular bioimaging] field and the people who want to use [the technologies of] that field but are not in it,” he said.

Dr. Mendelsohn also noted one important omission in the workshop. The planning committee had hoped to address the topic of sharing intellectual property in greater detail, but the expert invited to speak about intellectual property issues unfortunately had to cancel the week of the meeting. Noting that this would be an essential topic for a consensus committee to address, Dr. Mendelsohn asserted that “we have got to figure out a way to incentivize.” “You have to show [the stakeholders] that it is to their advantage [to share intellectual property],” he said.

Drs. Mendelsohn and Moses both noted that important policy issues had been identified and explored in each session, and that these issues would benefit from further study. Accordingly, this summary of the conference proceedings will serve as input to the deliberations of an Institute of Medicine committee that will develop consensus-based recommendations for moving the field of cancer clinical trials forward.

Numerous suggestions were put forth by speakers and discussion groups, including the following:

  • Consider adaptive methods more often in designing clinical trials.

  • Consider increased use of Phase 0 trials for addressing early biological endpoints in patients and for compound triage when multiple compounds are being considered.

  • Increase efforts to standardize and harmonize imaging methodologies used in clinical trials.



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0 WORKSHOP SUMMARY party payors more likely, he added. Finally, he pointed out that biomarker- based trial designs will narrow down the population most likely to benefit and therefore reduce sample size and toxicity, and provide opportunities for enrollment in other trials. CONCLUDING REMARKS In final closing comments before adjourning the meeting, planning committee co-chairs Drs. Moses and Mendelsohn both commended the quality of the presentations and subsequent discussions. Dr. Mendelsohn remarked that a valuable outcome from the meeting was “educating each other in this room.” For example, “clearly there was tremendous cross com- munication between the people that are in [the molecular bioimaging] field and the people who want to use [the technologies of ] that field but are not in it,” he said. Dr. Mendelsohn also noted one important omission in the workshop. The planning committee had hoped to address the topic of sharing intel- lectual property in greater detail, but the expert invited to speak about intellectual property issues unfortunately had to cancel the week of the meet- ing. Noting that this would be an essential topic for a consensus committee to address, Dr. Mendelsohn asserted that “we have got to figure out a way to incentivize.” “You have to show [the stakeholders] that it is to their advantage [to share intellectual property],” he said. Drs. Mendelsohn and Moses both noted that important policy issues had been identified and explored in each session, and that these issues would benefit from further study. Accordingly, this summary of the conference pro- ceedings will serve as input to the deliberations of an Institute of Medicine committee that will develop consensus-based recommendations for moving the field of cancer clinical trials forward. Numerous suggestions were put forth by speakers and discussion groups, including the following: • Consider adaptive methods more often in designing clinical trials. • Consider increased use of Phase 0 trials for addressing early biologi- cal endpoints in patients and for compound triage when multiple compounds are being considered. • Increase efforts to standardize and harmonize imaging methodolo- gies used in clinical trials.