Roll of Clinical Research Coordinators (CRC) in Ensuring that Clinical Trials are Conducted Properly-Study on the CRC Support for Patient Enrollment, Exclusion and Withdrawal-

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  • 適正な治験実施のための薬剤師治験コーディネーターの役割―スクリーニング支援と治験中止例への対応―
  • Study on the CRC Support for Patient Enrollment, Exclusion and Withdrawal
  • スクリーニング支援と治験中止例への対応

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To ensure that clinical trials are conducted in accordance with the new GCP guidelines, our pharmacists started acting as clinical research coordinators (CRC) in November, 1999.<BR>In the present study, we examined the CRC's support of the enrollment and withdrawal of patients for clinical trials. Between November, 1999 and April, 2003, a total of 138 patients had originally been enrolled for trials but on the basis of closer examination by CRCs, 31 of these patients (22.5%) were considered to be in contravention of the inclusion criteria. For 64.5 % of them (20/31), there were problems with drugs in their prescriptions from other hospitals or our own hospital, involving contraindicated drugs or drugs given to treat complications.<BR>Regarding withdrawal from trials, 28.6% (6/21 patients) stopped participating voluntarily suggesting that a large number of patients had feelings of anxiety concerning the effects of the new drugs and their adverse reactions.<BR>We felt that the efforts of CRCs in checking prescriptions for problem-causing drugs prior to obtaining patient consent to participate in trials and continuous follow-up of subjects during trials were very useful, and that pharmacists can make an important contribution to ensuring that clinical trials are conducted properly.

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