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Clinical Trials Cannot be Done Without an FDA-Cleared IND
(Thursday, December 15, 2022) It should be a moot point that clinical trials cannot be conducted without filing an IND application with the FDA and waiting for the FDA clearance prior to initiating the trial in patients. It also should be a moot point that IRB approval alone is not sufficient to initiate clinical trials with drugs and biologics. But still many physicians run clinical trials on their unsuspecting patients without an IND. Last year alone, FDA issued about 12 Warning Letters to physicians conducting illegal clinical trials (i.e., trials without INDs) and many more FDA 483s. And this barely scratches the surface. Study of these Warning Letters provides a useful primer on the excuses used by the offending physicians to justify their trails to the FDA inspectors when caught in the act. In the latest such Warning Letter, the physician first claimed to the FDA that he and IRB did not deem his trial to require an IND or and IDE (the device clinical trial application). The physician contended that his trial with a device-drug combo product was a non-significant risk device trial with a generally recognized as safe (GRAS) substance. The GRAS designation does not apply to drugs and combination products regulated as drugs based on their primary mode of action cannot be considered for non-significant risk determination. It seems that the physician provided erroneous information to his IRB as well since after initially approving his trial, the IRB withdrew approval and instructed him to file an IND. Then the physician temporarily halted recruitment of patients to his trial, filed an IND and immediately started the trial once FDA acknowledged receiving the IND and did not wait for the statutory duration of 30 days post-IND filing for FDA to clear the IND or provide its comments to the IND. The IND did not contain a clinical protocol, submitted information about a different trial than what was initiated, and contained incomplete and inaccurate information about the trial and the investigational product. It seems that investigators neither himself have adequate information about the IND filing requirements nor did he hire appropriate regulatory support for his IND. All the findings in the Warning Letter are routine information for any person trained in IND and clinical trial regulatory requirements and are easy to address. Unfortunately, this is not an isolated incidence. In the past, people have used similar false pretenses such as registering trials on clinicaltrials.gov and claiming to be “FDA Registered”, getting approval from illegal or improperly formed IRBs, create pay-to-participate trials, and using erroneous self-assessment of IND applicability for their trial(s) to lure patients into illegal clinical trials. FDA does not have the resources to police all such trials. It only finds about such trials either by sheer chance or when there are complaints. And there are few serious consequences for the defaulters other than stopping their trials and going back to normal life post-Warning Letters. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: mkumar@fdamap.com Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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