Conducting clinical research is difficult. Patients need to be protected, protocols adhered to, results meticulously recorded and hundreds of regulations followed. And when all is said and done, the US Food and Drug Administration (FDA) estimates that complying with its clinical trial regulations takes almost 23 million hours each year.
FDA regulates clinical trials under Chapter 21 of the Code of Federal Regulation, Section 312 (21 CFR 312). The section explains the extensive requirements for submitting and maintaining what is known as an investigational new drug application, better known as an IND.
An IND is the precursor to a New Drug Application (NDA), which is used to seek full marketing approval from FDA. Because it is illegal to distribute a drug that has not yet received FDA approval, an IND is technically a request to exempt an investigational drug from interstate commerce laws. If an IND is approved (which typically happens within 30 days), a sponsor is allowed to—within the limits of FDA's approval—ship its drug to clinical trial centers and allow patients enrolled in the trial to access the drug.
21 CFR 312 contains extensive requirements meant to ensure patients are kept safe throughout a trial, and that results obtained from a trial are trustworthy and suitable for use in a marketing application.
Those requirements can be simple to comply with, or they can be extraordinarily complex. Take, for example, 312.52(a)—a section allowing an IND sponsor to transfer its obligations to a contract research organization (CRO) as long as they describe the transfer and the CRO's obligations in writing to FDA. The agency said it estimates this step to take two hours on average to complete.
In contrast, consider 21 CFR 312.23, IND content and format—the regulation covering the form the IND should take and the information that it should include. For both drugs and biological products, FDA estimates that completing this section will take a total of 1,600 hours.
In all, FDA estimates that pharmaceutical and biological companies will, in an average year, spend 22,801,297 hours complying with its reporting and recordkeeping requirements for INDs. The vast majority of that time will be spent on reporting requirements, FDA's data show.
|Estimated Annual Burden|
|Reporting Burden for Human Drugs ||19,134,039|
|Reporting Burden for Biologics ||3,254,062|
|Recordkeeping Burden for Human Drugs ||286,190|
|Recordkeeping Burden for Biologics ||127,006|
FDA's estimates do not take into account capital, operating or maintenance costs associated with conducting clinical research, it said, which could make the true costs of compliance more expensive in both money and time.
Federal Register Notice