Survey on the Attitudes of Citizens toward Genetic Analysis Studies Associated with Clinical Trials Planned by the Pharmaceutical Industry

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  • Momo Kenji
    Tsukuba Clinical Research and Development Organization (T-CReDO), University of Tsukuba Clinical Trial and Research Network IBARAKI Faculty of Pharmaceutical Sciences, Teikyo Heisei University
  • Yamada Takeshi
    Tsukuba Clinical Research and Development Organization (T-CReDO), University of Tsukuba Clinical Trial and Research Network IBARAKI
  • Tsurushima Hideo
    Tsukuba Clinical Research and Development Organization (T-CReDO), University of Tsukuba Clinical Trial and Research Network IBARAKI
  • Arakawa Yoshihiro
    Tsukuba Clinical Research and Development Organization (T-CReDO), University of Tsukuba

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Other Title
  • 一般市民を対象とした企業主導治験に伴う遺伝子解析研究に 対する意識調査
  • イッパン シミン オ タイショウ ト シタ キギョウ シュドウチケン ニ トモナウ イデンシ カイセキ ケンキュウ ニ タイスル イシキ チョウサ

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Objective: Owing to the recent advances in genetic analysis technology, its application in drug development is expected to increase, although there are concerns regarding the leakage of personal information.  This study aimed to assess the attitudes of community citizens toward genetic analysis studies associated with clinical trials planned by the pharmaceutical industry.<br>Methods: A questionnaire survey was conducted after an educational seminar on drug development at a university campus festival.  Answers were obtained from 47 citizens (16 males and 31 females, ages ranging from teens to fifties).<br>Results: Attitudes toward providing genome samples were assessed using a 100-mm visual analogue scale, and the data revealed significant differences in the conditions of sample use (A, limited to specific genes during the trial, 89±14 mm; B, limited to genes related to the test drug or target disease, 81±23 mm; C, unlimited, 71±33 mm, p<0.01).  Twenty-seven citizens (57%) consistently expressed acceptance toward all three conditions.  The remaining 38% (n=18) expressed denial as the analysis targets widened.  Regarding the acceptable period for sample storage, 17 citizens (36%) allowed “indefinite storage” but 14 citizens (30%) requested “immediate disposal after analysis.”  A feedback on the accidental findings of abnormalities was requested by 43 citizens (91%).<br>Conclusion: The results demonstrated a wide variety of attitudes toward providing samples.  On the other hand, most citizens requested a feedback on the findings of abnormalities for disease-related genes.  These results suggest that it is necessary to improve the study protocol to reflect these fears and expectations.

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