There’s been a rising concern with clinical trial fraud and misconduct, particularly over the number of “zombie” trials that have been discovered in recent years — that is, trials in which a portion of the data is either invented out of whole cloth or is manipulated to the point of dishonesty. Researchers should expect greater scrutiny from both sponsors and regulators and should make sure their data integrity plans are solid to catch any bad actors before they can irreparably tarnish a study.
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Clinical researchers could avoid the bulk of FDA inspection issues that might impact their organization by following study protocols to the letter and making sure documentation and record-keeping practices are beyond reproach. But that’s easier said than done. The growing complexity of clinical trials, ever-expanding data points, new management technologies and differing experience levels among staff all combine to make this a challenge.
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The FDA has offered greater direction on demonstrating substantial evidence of effectiveness for drugs and biologics, publishing draft guidance with considerations for deciding whether a single trial plus confirmatory evidence will suffice for a development program.
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The FDA has expanded the scope of its guidance on conducting clinical trials during the COVID-19 pandemic to apply to public health emergencies (PHE) and other disasters, issuing a rare direct-to-final guidance for immediate implementation.
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After nine years in draft form and 127 comments received from stakeholders, the FDA has finalized its guidance on informed consent, adding a question-and-answer section that addresses specific issues.
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In new final guidance, the FDA shares key recommendations for IRBs to consider when reviewing individual expanded access submissions, including advice on handling nonemergency requests for single patients and requests for pediatric patients.
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A draft guidance issued by the FDA last week advises developers of devices to treat opioid use disorder (OUD) to design clinical trials that address the problems of inaccurate participant reports of drug use, high rates of missing data and the effects of concomitant drug treatments.
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