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24. A retrospective analysis conducted by the Medicines Control Agency in the UnitedKingdom found that company-sponsored post-marketing surveillance studies have made only a limited contribution to the assessment of drug safety, largely due to weak study designs and recruitment difficulties. Waller PC, Wood SM, Langman MJS, Breckenridge AM, Rawlins MD. Similarly an audit conducted by a consumer protection organization in the United States shows that in the vast majority of cases where a Phase IV study was required as a condition of registration in the United States, the applicant did not fulfil such obligations. Sasich LD, Lurie P, Wolfe SM. The Drug Industry’s performance in finishing post-marketing research (Phase IV) studies. http://www.citizen.org/hrg/Publications/1520.htm
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68. New Zealand, Sweden, United Kingdom, USA and Canada are some examples ofcountries that have implemented active surveillance systems, with good results. For example in: Chen RT, DeStefano F, Davis RL, Jackson LA, Thompson RS, et al. The vaccine safety data link: immunization research in health maintenance organizations in the USA. Bulletin of the World Health Organization 2000; 78(2): 186-194; Coulter DM. The New Zealand intensive medicines monitoring programme in pro-active safety surveillance. Pharmacoepidemiology and Drug Safety 2000; 9:273-280; and Turner C, Mowat D. Addressing Health Surveillance Data Gaps. Health Canada 1999.
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79. An example of such a collaborative effort is the World Health Organization Global Vaccine Safety Advisory Committee. This committee has the specific goal of conducting independent scientific assessment on the causal association between administration of vaccines and the occurrence of specific reactions. The committee has been allocated a contingency fund to conduct emergency studies, if required, to determine whether causal associations exist. The committee was established in response to vaccine scares and rumours, which had dramatically affected immunization coverage in many countries. Anon. Vaccine Safety: Vaccine Safety Advisory Committee. Weekly Epidemiological Record 1999; 74:337-8.
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