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New federal regulations aim to strengthen the current requirements on reporting of clinical trial information.
The new rule offers a checklist to help determine which clinical trials are subject to regulations and who is responsible for information that appears on ClinicalTrials.gov. In addition, the rule does the following:
• Expands the scope of trials for which results must be submitted to include Food and Drug Administration–regulated products that have not yet been approved, licensed, or cleared.
• Requires additional information be submitted to ClinicalTrials.gov, including demographic information about trial participants.
• Expands adverse-event reporting.
• Adds potential penalties for noncompliance.
Current federal requirements for reporting of clinical trial information were originally enacted as part of the FDA Amendments Act of 2007. However, a 2015 analysis of trials listed on ClinicalTrials.gov from 2007 to 2012 found a woeful lack of compliance: Study results were posted for 13% of trials covered by reporting requirements (N Engl J Med. 2015;372:1031-9).
“Organizations will need to ensure that their systems, procedures, and organizational values all promote complete and timely clinical trial reporting,” wrote Deborah Zarin, MD, of the National Library of Medicine, Bethesda, Md., and her colleagues in a special report on the final rule (N Engl J Med. 2016 Sep 16. doi: 10.1056/NEJMsr1611785). “In the end, the parties responsible for clinical trials will be held accountable by the public.”
The final rule applies to most interventional studies of drugs, biologics, and devices regulated by FDA, but it will not apply to phase I trials of pharmaceuticals or small feasibility studies of devices. It specifies how and when information collected in a clinical trial should be collected and submitted to ClinicalTrials.gov but does not dictate how clinical trials should be designed or conducted.
“Expanding the registration information in ClinicalTrials.gov improves people’s ability to find clinical trials in which they may be able to participate and access investigational therapies,” NIH officials said in a statement. “More information about the scientific results of trials, whether positive or negative, may help inform healthcare providers and patients regarding medical decisions. Additional information will help researchers avoid unnecessary duplication of studies, focus on areas in need of study and improve study design, ultimately advancing the development of clinical interventions.”
“Many U.S. academic medical centers, including those that conduct the most clinical trials, will find that the majority of their clinical trials fall under the [FDA Amendments Act], the NIH policy, or both,” Dr. Zarin and her colleagues wrote. “We hope that sponsors and other relevant entities will go considerably above and beyond the minimum requirements and expectations, making an effort to honor the contributions of all study participants and ensure that others in the scientific community have access to complete and high-quality information about every clinical trial under their stewardship.”
The final rule was published in the Federal Register on Sept. 21 and becomes effective on Jan. 18, 2017.
AGA Resource
The AGA Center for Diagnostics and Therapeutics was created to provide objective, independent guidance to companies, regulators, investors and health-care professionals on the development of new therapies and diagnostics tests for digestive disorders. Learn more at http://www.gastro.org/about/initiatives/aga-center-for-diagnostics-and-therapeutics.
New federal regulations aim to strengthen the current requirements on reporting of clinical trial information.
The new rule offers a checklist to help determine which clinical trials are subject to regulations and who is responsible for information that appears on ClinicalTrials.gov. In addition, the rule does the following:
• Expands the scope of trials for which results must be submitted to include Food and Drug Administration–regulated products that have not yet been approved, licensed, or cleared.
• Requires additional information be submitted to ClinicalTrials.gov, including demographic information about trial participants.
• Expands adverse-event reporting.
• Adds potential penalties for noncompliance.
Current federal requirements for reporting of clinical trial information were originally enacted as part of the FDA Amendments Act of 2007. However, a 2015 analysis of trials listed on ClinicalTrials.gov from 2007 to 2012 found a woeful lack of compliance: Study results were posted for 13% of trials covered by reporting requirements (N Engl J Med. 2015;372:1031-9).
“Organizations will need to ensure that their systems, procedures, and organizational values all promote complete and timely clinical trial reporting,” wrote Deborah Zarin, MD, of the National Library of Medicine, Bethesda, Md., and her colleagues in a special report on the final rule (N Engl J Med. 2016 Sep 16. doi: 10.1056/NEJMsr1611785). “In the end, the parties responsible for clinical trials will be held accountable by the public.”
The final rule applies to most interventional studies of drugs, biologics, and devices regulated by FDA, but it will not apply to phase I trials of pharmaceuticals or small feasibility studies of devices. It specifies how and when information collected in a clinical trial should be collected and submitted to ClinicalTrials.gov but does not dictate how clinical trials should be designed or conducted.
“Expanding the registration information in ClinicalTrials.gov improves people’s ability to find clinical trials in which they may be able to participate and access investigational therapies,” NIH officials said in a statement. “More information about the scientific results of trials, whether positive or negative, may help inform healthcare providers and patients regarding medical decisions. Additional information will help researchers avoid unnecessary duplication of studies, focus on areas in need of study and improve study design, ultimately advancing the development of clinical interventions.”
“Many U.S. academic medical centers, including those that conduct the most clinical trials, will find that the majority of their clinical trials fall under the [FDA Amendments Act], the NIH policy, or both,” Dr. Zarin and her colleagues wrote. “We hope that sponsors and other relevant entities will go considerably above and beyond the minimum requirements and expectations, making an effort to honor the contributions of all study participants and ensure that others in the scientific community have access to complete and high-quality information about every clinical trial under their stewardship.”
The final rule was published in the Federal Register on Sept. 21 and becomes effective on Jan. 18, 2017.
AGA Resource
The AGA Center for Diagnostics and Therapeutics was created to provide objective, independent guidance to companies, regulators, investors and health-care professionals on the development of new therapies and diagnostics tests for digestive disorders. Learn more at http://www.gastro.org/about/initiatives/aga-center-for-diagnostics-and-therapeutics.
New federal regulations aim to strengthen the current requirements on reporting of clinical trial information.
The new rule offers a checklist to help determine which clinical trials are subject to regulations and who is responsible for information that appears on ClinicalTrials.gov. In addition, the rule does the following:
• Expands the scope of trials for which results must be submitted to include Food and Drug Administration–regulated products that have not yet been approved, licensed, or cleared.
• Requires additional information be submitted to ClinicalTrials.gov, including demographic information about trial participants.
• Expands adverse-event reporting.
• Adds potential penalties for noncompliance.
Current federal requirements for reporting of clinical trial information were originally enacted as part of the FDA Amendments Act of 2007. However, a 2015 analysis of trials listed on ClinicalTrials.gov from 2007 to 2012 found a woeful lack of compliance: Study results were posted for 13% of trials covered by reporting requirements (N Engl J Med. 2015;372:1031-9).
“Organizations will need to ensure that their systems, procedures, and organizational values all promote complete and timely clinical trial reporting,” wrote Deborah Zarin, MD, of the National Library of Medicine, Bethesda, Md., and her colleagues in a special report on the final rule (N Engl J Med. 2016 Sep 16. doi: 10.1056/NEJMsr1611785). “In the end, the parties responsible for clinical trials will be held accountable by the public.”
The final rule applies to most interventional studies of drugs, biologics, and devices regulated by FDA, but it will not apply to phase I trials of pharmaceuticals or small feasibility studies of devices. It specifies how and when information collected in a clinical trial should be collected and submitted to ClinicalTrials.gov but does not dictate how clinical trials should be designed or conducted.
“Expanding the registration information in ClinicalTrials.gov improves people’s ability to find clinical trials in which they may be able to participate and access investigational therapies,” NIH officials said in a statement. “More information about the scientific results of trials, whether positive or negative, may help inform healthcare providers and patients regarding medical decisions. Additional information will help researchers avoid unnecessary duplication of studies, focus on areas in need of study and improve study design, ultimately advancing the development of clinical interventions.”
“Many U.S. academic medical centers, including those that conduct the most clinical trials, will find that the majority of their clinical trials fall under the [FDA Amendments Act], the NIH policy, or both,” Dr. Zarin and her colleagues wrote. “We hope that sponsors and other relevant entities will go considerably above and beyond the minimum requirements and expectations, making an effort to honor the contributions of all study participants and ensure that others in the scientific community have access to complete and high-quality information about every clinical trial under their stewardship.”
The final rule was published in the Federal Register on Sept. 21 and becomes effective on Jan. 18, 2017.
AGA Resource
The AGA Center for Diagnostics and Therapeutics was created to provide objective, independent guidance to companies, regulators, investors and health-care professionals on the development of new therapies and diagnostics tests for digestive disorders. Learn more at http://www.gastro.org/about/initiatives/aga-center-for-diagnostics-and-therapeutics.