ASCO recently submitted two comment letters from ASCO President Monica M. Bertagnolli, MD, FACS, FASCO, to the Food and Drug Administration (FDA) Commissioner Scott Gottlieb related to the modernization of clinical trials.
The first letter provided the FDA with comments on its draft guidance, “Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics.” ASCO included suggestions on the use of multiple expansion cohorts for first-in-human clinical trials to expedite the development of oncology drugs and products. The letter noted that ASCO agrees with the direction of the guidance, particularly in terms of safeguards for patients, but provided necessary clarifications and suggestions for the agency as they move forward with it.
The second letter addressed the draft guidance, “Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development.” ASCO was pleased to see the FDA propose guidance on the use of placebos and when placebo designs can be useful, but also consider the practical and ethical concerns of using a placebo in hematologic malignancy and oncologic diseases. The letter also noted that the guidance was reflective of a Journal of Clinical Oncology article from 2008 on Ethical, Scientific and Regulatory Perspectives Regarding the Use of Placebos in Cancer Clinical Trials that examines the use of placebos in cancer clinical trials from all three perspectives of ethical, scientific, and regulatory to provide considerations and criteria for their appropriate use in cancer development.
ASCO always appreciates the opportunity to provide these comments, clarifications, and additional considerations to FDA in its efforts to modernize clinical trials. The Society looks forward to continuing to work with the FDA as it develops the guidance in these areas.
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