Aug 29, 2012
ASCO Cancer Research Committee member Christine Chung, MD, represented ASCO at an FDA public hearing this spring on modernizing the regulatory framework that governs clinical trials. In her testimony, Dr. Chung stressed the importance of harmonizing federal agencies, adopting alternative trial designs, promoting targeted therapies, encouraging patient engagement, and developing and adopting innovative clinical trials methods and models.
Dr. Chung urged the FDA to both collaborate with sister agencies that have oversight of cancer research and develop uniform policies across all types of research. She specifically encouraged future efforts to focus on conflict of interest disclosure, adverse events reporting, privacy requirements, and central institutional review boards.
“In the oncology field, many of us are involved in research that is subject to multiple federal agencies, so this overall coordination and harmonization would have a great impact,” she said in her statement. “Greater consistency in regulations, guidance, and interpretation would be beneficial for researchers who want to follow the rules, but may be confused by the process.”
Dr. Chung also emphasized the need for a speedier research process and recommended that the FDA focus on endpoints that impact clinical decision-making. The adoption of innovative methods and models can be achieved “through increased promotion of new approaches that have proven successful,” she said.
Regarding targeted therapies and companion diagnostics, Dr. Chung encouraged the FDA to continue its collaboration with NCI’s Clinical Assay Development Program. Furthermore, she recommended that the FDA publish a menu of previously validated biomarkers and tests because “resources like this will be extremely helpful to investigators who specialize in this important and evolving field of research.” She also encouraged increased efforts to promote collaborative international research because “as targeted therapies give us smaller subpopulations for trials, we’ll need to increasingly look overseas for the necessary participation to complete trials.”
Greater patient engagement in the research process as well as increasing the involvement of patient advocates on advisory committees and in public hearings was another area of emphasis in Dr. Chung’s testimony. “It is important to recognize the influential role patient advocates can play in the success of clinical research, particularly in the study of rare diseases where limited numbers of patients are available for clinical trials,” she said. In order to “fulfill the pledge we make to trial participants to maximize the value of their involvement in research,” the FDA has “an important role to play in enforcing the requirements of results reporting through clinicaltrials.gov.”
Dr. Chung also discussed the importance of collaboration among stakeholders—both through ASCO’s rapid learning system, CancerLinQ™, and by means of an assessment module being developedby a subgroup of ASCO’s Cancer Research Committee. Dr. Chung concluded her testimony by stating, “It is inspiring to imagine what can be accomplished under the modernized regulatory system the FDA is committed to developing.”
Following the public hearing—titled “Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice”—ASCO submitted a letterto FDA Commissioner Margaret Hamburg, MD, which further emphasizedDr. Chung’s statement. To read the comment letter, visit tinyurl.com/HamburgLetter.
Dr. Chung urged the FDA to both collaborate with sister agencies that have oversight of cancer research and develop uniform policies across all types of research. She specifically encouraged future efforts to focus on conflict of interest disclosure, adverse events reporting, privacy requirements, and central institutional review boards.
“In the oncology field, many of us are involved in research that is subject to multiple federal agencies, so this overall coordination and harmonization would have a great impact,” she said in her statement. “Greater consistency in regulations, guidance, and interpretation would be beneficial for researchers who want to follow the rules, but may be confused by the process.”
Dr. Chung also emphasized the need for a speedier research process and recommended that the FDA focus on endpoints that impact clinical decision-making. The adoption of innovative methods and models can be achieved “through increased promotion of new approaches that have proven successful,” she said.
Regarding targeted therapies and companion diagnostics, Dr. Chung encouraged the FDA to continue its collaboration with NCI’s Clinical Assay Development Program. Furthermore, she recommended that the FDA publish a menu of previously validated biomarkers and tests because “resources like this will be extremely helpful to investigators who specialize in this important and evolving field of research.” She also encouraged increased efforts to promote collaborative international research because “as targeted therapies give us smaller subpopulations for trials, we’ll need to increasingly look overseas for the necessary participation to complete trials.”
Greater patient engagement in the research process as well as increasing the involvement of patient advocates on advisory committees and in public hearings was another area of emphasis in Dr. Chung’s testimony. “It is important to recognize the influential role patient advocates can play in the success of clinical research, particularly in the study of rare diseases where limited numbers of patients are available for clinical trials,” she said. In order to “fulfill the pledge we make to trial participants to maximize the value of their involvement in research,” the FDA has “an important role to play in enforcing the requirements of results reporting through clinicaltrials.gov.”
Dr. Chung also discussed the importance of collaboration among stakeholders—both through ASCO’s rapid learning system, CancerLinQ™, and by means of an assessment module being developedby a subgroup of ASCO’s Cancer Research Committee. Dr. Chung concluded her testimony by stating, “It is inspiring to imagine what can be accomplished under the modernized regulatory system the FDA is committed to developing.”
Following the public hearing—titled “Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice”—ASCO submitted a letterto FDA Commissioner Margaret Hamburg, MD, which further emphasizedDr. Chung’s statement. To read the comment letter, visit tinyurl.com/HamburgLetter.