FDA clinical trial failures

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Now, we have contributing correspondent Charles, pillar. He wrote an investigative feature on SDA's serious decline in protections for patients and for data integrity. Hi, Charlie Hey Sarah, I'm not sure everyone knows that FDA has oversight of clinical trials. What exactly is this agency's role with respect to human trials? The FDA is vast agency with many responsibilities, and in this case, it has two elements of control over the quality of trials. One is whether patients are properly protected during the trials in also whether the data generated from these trials is reliable in his in keeping with the important goal of the FDA of approving drugs and devices that actually were but as you. Found in your investigation, the FDA enforcement has been light-handed slow moving and secretive. You give us some examples that you found shoddy clinical research practices, poor record-keeping that you came across in your dive into this one example that comes to mind as a organization in Utah that is a contract research organization that does clinical trials on behalf of drug companies. This isn't orgainzation that had enormous problems spanning almost decade problems with informed consent problems associated with conduct, its trials that called into question the integrity of the data in also the safety of volunteers these trials for serious kinds of drugs, end devices, including opiates, antidepressants, antipsychotic drugs, drugs for Alzheimer's and threats and. Other pretty serious ailments. What we found in looking at the FDA evaluations is that there were really serious problems that the agency itself warned the investigators might constitute for scientific misconduct, significant human subjects, protection violations, and perplexingly despite for investigations, the agency never cited this Organization for anything beyond just saying look, you're doing a bad job here. Now, never a warning letter never required any changes in the procedures. It never insisted that the principal investigator change operations in a way that would save our patients and data I just want to emphasize how important it is to protect people involved in clinical trials. Medical Experiments on human beings. and. There's a long history of unsafe practices in the bad old days. There were a lot of abuses of human subjects these days. There are pretty stringent requirements that there be informed consent of the patients who are participating in these trials that there be a very rigorous review of the trial so that these patients are well protected. The FDA looks both that the investigators and the Institutional Review Boards called I IRB's that are responsible for overseeing these experiments and what they often learn is that not just our the investigator's making mistakes or hindering their experiments in a cavalier or unsafe way but also the investigation process the review of that by the IRS. Is often not very adequate in the IRBE's themselves perhaps are run amateurishly or in a way that does not protect. Patients were the quality of the data that's generated by the experience. This is an investigative piece you've spent almost a year gathering information. What kinds of evidence did you collect well to basically every public source of data that the FDA publishes associated with their review of trials in? So that includes summaries in their various databases online. It also includes warning letters, which is when serious mistakes are made. They might warn the investigator or the I. R.. That they've got a problem that needs to be fixed, I also looked at the inspection reports that were available through the freedom of information, act on hundreds of these cases these are pretty difficult to obtain because the reports are only available under the foia in as a result, it can take weeks months sometimes years to get access to them. So what I'm trying To convey here is that this is a very difficult process. The actually lured what happened in the FDA's evaluation of these organizations because oftentimes they do not announce publicly what happened what about the drug companies that hire these institutions to carry out this research when there's really agreed just problems going on the worst case scenario is that a clinical scientist who was doing? These experiments can be disqualified from future research. This is for someone who has broken the rules and such agreed sway that they've endanger patients that they've intentionally submitted false data to the FDA here to the sponsor of the experiment. When that happens, there's no doubt that the companies who sponsored the specific experiments that were found to have been either fraudulent or so badly. Flawed those timed they're informed of it. The problem is that many times even those experimenters their long history of research is just sort of a black box. No one looks back to see him. They made similar egregious errors or conducted experiments that were tainted by fraud.

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