Postmarket Clinical Studies

The applicant should also describe any proposed postmarketing clinical studies and the reasons for doing such studies, e.g., to study further a suspected adverse reaction, or studies in children if there is a potential for use in this group. 

Phase IV. Studies or trials conducted after a medicine is marketed to provide additional details about the medicine s efficacy or safety profile. Different formulations, dosages, durations of treatment, medicine interactions, and other medicine comparisons may be evaluated. New age groups, races, and other types of patients can be studied. Detection and definition of previously unknown or inadequately quantified adverse reactions and related risk factors are an important aspect of many Phase IV studies. If a marketed medicine is to be evaluated for another (i.e., new) indication, then those clinical trials are considered Phase II clinical trials. The term postmarketing surveillance is frequently used to describe those clinical studies in Phase IV (i.e., the period following marketing) that are primarily observational or nonexperimental in nature, to distinguish them from well-controlled Phase IV clinical trials or marketing studies. 

Reviewer Training Introduction to the Regulatory Process, which includes an orientation to CBER, INDs, clinical studies, and postmarketing surveillance... 

Changes based on postmarketing study results, including, but not limited to, labeUng changes associated with new indications and usage. Change in, or addition of, pharmacoeconomic claims based on clinical studies. 

The information on safety provided by the controlled trials are of course valuable, but the populations are highly selected and the administration of SLIT is usually supervised this situation is profoundly different from that occurring in the clinical reality. Therefore, more consistent information on the safety should be obtained when SLIT is prescribed and administered in the everyday clinical practice, i.e. in postmarketing surveillance studies. 

As mentioned before, LNIT requires a particular administration technique after premedication, the allergenic extract (aqueous or powdered) has to be sprayed into a nostril while vocalizing. This fact, in addition to the efficacy limited to the nose, reduced the clinical use of LNIT therefore, no postmarketing surveillance studies are available. In conclusion, based on the clinical trials, LNIT appears safe and well tolerated. The EAACI/ESPACI position paper states that side effects do not represent a problem [12],... 

Phase IV commitments are agreements made between the agency and sponsors to conduct postapproval studies for the purpose of gathering further safety and efficacy information. Under the FDA Modernization Act of 1997, applicants are required to submit annual reports on the status of postmarketing commitments. Additionally, under FDAMA, marketing an approved product for off-label claims would be allowed, providing one or more clinical study corrobates safety and efficacy. 

Drug discovery requires a host of inputs, new ideas, design and synthesis of substances, evaluation of preclinical toxicity tests in animals, clinical studies in human volunteers, permission to market the drug, postmarketing studies of safety, and comparison with other medicines. Drug development is highly technical and enormously expensive, with a success rate of 1 in 10,000 compounds. 

A review of the prechnical studies, clinical studies, and postmarketing surveillance data has given no support to the proposed association between bambuterol and cardiac failure. The UK Committee on Safety of Medicines has received no spontaneous reports of cardiac failure due to bambuterol. Data from the WHO database, INTDIS, show no reports of cardiac failure with bambuterol, in contrast to ten reports for salmeterol. 

Clinical trials in which it would be unethical to use a double-blind design Some large, multicentre postmarketing surveillance studies, in which a comparison of the newly marketed drug and standard therapy is made... 

These deliberations may result in several outcomes. Clinical development may continue as planned, but additional vigilance with more frequent visits and special tests may be added. The dose may be reduced or certain at-risk subjects may be excluded from further trials. The drug may proceed to registration, but the authorities may stipulate that a postmarketing surveillance study be conducted. The drug may be withdrawn from further clinical development. 

Market research activities, postmarketing surveillance studies, clinical assessments and the like must not be disguised promotion. 

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