| CenterWatch

Fraudulent ‘zombie’ trials live on in literature, impacting future research

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. Read More

Focus on training, preparedness to avoid BIMO inspection problems

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. Read More

FDA Expands on Showing Effectiveness in a Single Trial with Confirmatory Data

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offered greater direction on demonstrating substantial evidence of effectiveness for drugs and biologics, publishing draft guidance with considerations for deciding whether a single trial plus confirmatory evidence will suffice for a development program. Read More

FDA Broadens Pandemic-Era Guidance to Cover Trials During PHEs, Disasters

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. Read More

FDA Finalizes Guidance on Informed Consent Process

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. Read More

FDA Posts Final Guidance on IRB Reviews of Single Expanded Access Requests

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. Read More

FDA Guidance Gives Advice on Trial Designs for Opioid Use Disorder Devices

A draft guidance issued by the FDA last week advises developers of devices to treat opioid use disorder (OUD) to design clinical trials that address the problems of inaccurate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. Read More