In Brief

Le Bonheur Joins I-ACT

The Institute for Advanced Clinical Trials for Children (I-ACT) is a site network infrastructure of pediatric research sites created with funding from the U.S. Food and Drug Administration (FDA) with experts in conducting innovative and efficient pediatric trials.

By implementing standard processes and practices, the I-ACT network can shorten study startup time when approached by a sponsor to conduct a clinical trial. The I-ACT network engages stakeholders to generate discussion and launch groundbreaking initiatives that raise awareness of the need to advance medical therapies, specifically for children, and promote a sense of urgency to achieve this goal. Top children’s research organizations are in the network, including 62 sites in the U.S., Canada, Australia and Saudi Arabia.

On May 12, 2020, Le Bonheur Children’s Hospital was welcomed into the network, with the hope of expanding Le Bonheur’s clinical research portfolio to offer even more innovative and ground-breaking research to patients.

FDA announces guidance regarding penalties for non-compliance with applicable clinical trial registration

The FDA has released new guidance to address non-compliance with registration of applicable clinical trials on clinicaltrials.gov. Under the PHS Act, investigators are required to register applicable clinical trials on clinicaltrials.gov and report any results or publications associated with these trials. The FDA’s new guidance document indicates that investigators who do not register applicable clinical trials, fail to submit results of the trials or falsify trial records or results can be subject to monetary penalties. Upon discovery of non-compliance, the responsible party will receive a preliminary notice of non-compliance and will be given 30 calendar days after the notice is received to address the issue. After 30 days, the FDA will conduct further review of the submitted clinical trials information and associated documents. If the responsible party fails to comply, then the FDA may take further action, including monetary penalties, injunction or criminal prosecution. To avoid any penalties, please register all applicable clinical trials on clinicaltrials.gov and keep the trial information, such as recruitment, results and publications, up to date. If you have questions regarding this new guidance, please contact CFRI regulatory staff for more information.