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Phase IV trials

After a new drug has been approved by health authorities and launched in national markets, pharmaceutical companies usually conduct numerous further studies of its therapeutic performance in more extended patient populations. Some typical clinical and scientific goals pursued in Phase IV trials are  [Pg.193]

Furthermore, clinical trials are performed in various cultural and geographical settings. Transcultural differences may play a significant role in drug efficacy e.g. oriental populations require much lower doses of antipsychotic drugs compared with Caucasian patient populations. Phase IV trials also may be performed to explore possible novel uses for compounds approved and marketed in other indications (e.g. treatment of anxiety disorders with antidepressants, treatment of bipolar disorder with anticonvulsants, etc.). [Pg.194]

Phase IV trials must be conducted according to the same ethical, scientific and Good Clinical Practice standards as those required in Phase I III studies. A more detailed account on PMS studies can be found in a chapter by Hollister et al (1994). [Pg.194]


Distinguish the various phases of chnical trials, 1 to IV. Provide a reason for conducting Phase IV trials. [Pg.205]

Refer to Section 6.3 to describe the phases of a clinical trial. Phase IV trials are necessary to maintain a close watch on the efficacy and adverse events of an approved drug when it is administered to the population at large. For example, even a small percentage of adverse events in Phase III trial for several thousand people may translate into a substantial number when a drug is made available to milhons of people. A case in point is Vioxx and Bextra (see Section 2.9). [Pg.206]

Phase IV trials, like trials in Phases I-III, must be genuine investigations that are properly conducted and the data analysed. Free drug may not be given to doctors solely for them to use as they think fit. The restrictions do, however, reduce the chances for physicians to assess the new medicine personally and thus to form a roimded view of the product. The argument must therefore rest on clinical and scientific merit. [Pg.370]

Free drug must, however, be made available for Phase IV trials approved by the Ethics Committees. [Pg.370]

In case an application is made for initiating the Phase IV trial, complete details of the nonclinical safety data needed for obtaining the permissions for Phase I, II, and III trials, as per the list provided above, must be submitted... [Pg.24]

Pharmacokinetics is used in all the development stages of a drug from preclinical to Phase IV trials (see section 11.3). Legislation normally demands... [Pg.177]

The interpretation of the results of all trials requires the close collaboration of clinicians and statisticians. Reliable results are only obtained if at least the minimum number of patients for statistical viability are involved in the preliminary trials. It is often difficult to measure precisely the parameter chosen for assessment. Consequently, results are usually quoted in terms of a probability coefficient, the lower the value of this coefficient the more accurate the results. However, very reliable results will only be obtained from clinical trials if large groups of patients are tested. This is seldom feasible. Consequently, manufacturers and licencing authorities usually settle for the best statistical compromise. Since some adverse effects do not manifest themselves for years, it is necessary to constantly monitor the drug (Phase IV trials) after it has been released for general use. [Pg.234]

Phase IV trials are conducted as postmarketing efforts to further evaluate the characteristics of the new drug with regard to safety, efficacy, new indications for additional patient populations, and new formulations. Phase IV is generally used to characterize all post-NDA/BLA clinical development programs. However, some organizations use Phase IV to describe only FDA-requested clinical trials and use Phase V to describe internally motivated market expansion trials (e.g., new indications, new formulations, updated safety databases). [Pg.502]

In a large, uncontrolled, short-term Phase IV trial, adverse effects (moderate or severe) were reported by 21% of the patients, with withdrawal in 5.2%. Adverse effects were mainly gastrointestinal (nausea, stomachache, heartburn, diarrhea), CNS symptoms (headache, dizziness, sleep disturbances, fatigue), and skin rashes. [Pg.36]

In a phase IV trial, 66% patients with postherpetic neuralgia gained relief from a 5% hdocaine patch applied to the most painful area of the body (43). The lidocaine patch was well tolerated, a rash being the most common adverse effect, in 14% of patients. [Pg.2055]

For example, first-in-man studies and pivotal trials are more likely to be audited than phase IV trials, and external providers selected for the first time who are responsible for key areas in clinical trials should be audited with a higher priority than CROs with a long history and reliable performance. [Pg.166]

Eichacker RQ, Natanson C. Recombinant human activated protein C in sepsis Inconsistent trial results, an unclear mechanism of action, and safety concerns resulted in labeling restrictions and the need for phase IV trials. Crit Care Med 2003 31 594-96. [Pg.2143]

Not usually thought of as clinical trials but are similar to Phase IV trials . [Pg.157]

Rossi AC. Discovery of adverse drug reactions. A comparison of selected phase IV trials with spontaneous reporting methods. JAMA 1983 249 26-28. [Pg.245]

Phase IV chnical trials are those trials made after the marketing authorization. They may be asked for by the authorities in order to better evaluate the products long-term effects (if continued monitoring of patients from earher trials does not suffice) or to study the efficacy in pediatric patients or other not yet studied target patient groups), but also sometimes in case of a major change made to the manufacturing process after approval of the product. Phase IV trials may also be used by the manufacturer to test new indications or new routes of delivery for the product, other than the ones for which it has been approved (see also Part VI, Chapter 1). [Pg.1696]

Phase IV trials and surveillance begin after marketing starts. The trials continue much of the work of earlier studies that evaluated safety and efficacy. They also search for drug-drug interactions and side effects not previously detected. Because certain adverse effects afflict only tiny fractions of the treated population, some Phase IV trials necessarily involve many thousands of patients. Other studies compare and contrast the new drug to any existing ones for the same disease, search for new indications or patient populations, or look for information to assist in marketing. [Pg.57]

SchelUnger PD, Fiebach JB, Mohr A et al (2001) Thrombolytic therapy for ischemic stroke-a review. Part Il-Intra-arterial thrombolysis, vertebrobasilar stroke, phase IV trials, and stroke imaging. Crit Care Med 29 1819-1825... [Pg.261]


See other pages where Phase IV trials is mentioned: [Pg.74]    [Pg.254]    [Pg.239]    [Pg.91]    [Pg.435]    [Pg.215]    [Pg.193]    [Pg.194]    [Pg.28]    [Pg.233]    [Pg.4]    [Pg.258]    [Pg.57]    [Pg.198]    [Pg.120]    [Pg.124]    [Pg.504]    [Pg.523]    [Pg.477]    [Pg.429]    [Pg.426]   
See also in sourсe #XX -- [ Pg.28 , Pg.30 ]

See also in sourсe #XX -- [ Pg.429 ]




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