The publicity surrounding the issue has led to questions regarding what the present requirements, if any, for the listing of drug studies are. Some confusion was generated by an FDA reaction at the time of the Glaxo settlement, suggesting that requirements for the public listing of such trials were already in effect.
The truth is, as a general matter, they are not, though there are some existing requirements that apply to a more limited universe of studies. Enforcement of these requirements to date, however, has been limited, if not nonexistent. What follows is a brief discussion of the history and nature of these requirements.
Section 113 of the FDA Modernization Act of 1997 (codified at 28 USC 282) required the Department of Health and Human Services to establish a data bank of clinical trials for effectiveness of drugs for serious or life threatening diseases or conditions.
Paraphrasing the statute somewhat, the data bank is required to include a registry of clinical trials of experimental treatments, providing a description of the purpose of the experimental drug, when the trial begins, eligibility information, trial sites, a point of contact, and other information.
Similar information is required for treatment INDs for similar types of drugs and Group C cancer drugs. The criteria for determining whether a disease or condition was serious or life threatening was defined by FDA regulations (21 CFR 312.81), a principal purpose of which was for determining whether drugs are eligible for certain expedited or fast track review procedures.
The fairly obvious purpose of this statutory section is to advise members of the public about the existence of planned or ongoing clinical trials for serious or life-threatening diseases in order that they may be aware of them, and to facilitate enrollment when appropriate. This is quite evident from the registry itself, which is found at www.clinicaltrials.gov. The FDA has published the following guidance on this subject, found at www.fda.gov/cder/ guidance/4856FNL.PDF.
While it states that deciding which drug studies qualify for inclusion is ultimately a matter of judgment, it identifies relevant criteria for study inclusion in detail, and includes, by way of example, drug studies for diseases such as AIDS, HIV, Alzheimers disease, angina pectoris, heart failure, cancer, and others.
In addition, as the criteria include diseases which can be well managed using existing therapy, but which can have serious outcomes if unmanaged, the list also includes studies for diseases such as inflammatory bowel disease, asthma, rheumatoid arthritis, diabetes, depression, and others, including any drug obtaining a fast track designation.
Companies in the process of conducting effectiveness trials for the diseases identified above, or which fit the fairly expansive definition of serious or life threatening diseases, should examine whether those studies should be listed on the registry.
These are the only known governmental requirements of general applicability regarding the registration of clinical trials to date. Given the impetus created by the New York state settlements and the subsequent furor created by the Vioxx market withdrawal, expanded requirements, most significantly for studies of marketed drugs such as those involved in the New York litigation which the companies themselves are now voluntarily including in company-based registries, are essentially a certainty.