Drugs

CTTI Sees Barriers to Trial Reporting

FDA says the Clinical Trials Transformation Initiative has published a report of its findings from a collaborative project with the agency to understand the barriers to timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov. In the report, CTTI documented the experiences and perspectives of interested parties from academia, the medical product industry, and others on registering and submitting summary results information for applicable clinical trials into the Web site.

CTTI says respondents cited these major challenges:

a lack of understanding of the principal investigator and the study team about the type of trials that must be registered, when they should be registered, and which trial results must be submitted and when;
principal investigators and teams that are non-responsive to administration groups, hindering both timely registration and reporting of results of applicable clinical trials; and
waiting until all data are analyzed before reporting results information on ClinicalTrials.gov to prevent discrepancies between Web site data and published results.

Some of the strategies recommended in the report are:

using a centralized/dedicated approach to meeting ClinicalTrials.gov requirements;
taking a proactive approach to complying with ClinicalTrials.gov regulatory requirements;
escalating to upper levels of leadership for principal investigators/study teams that are non-responsive to the administrative unit’s communication about compliance;
informing principal investigators/study teams about the possibility of civil money penalties for non-compliance with ClinicalTrials.gov regulatory requirements, that submitting results information on ClinicalTrials.gov is separate from publishing results in journals, that reporting results information on the Web site does not preclude publishing results in journals; and
providing education, resources, guidance, and support about meeting ClinicalTrials.gov requirements to principal investigators/study teams and other research personnel.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome