Titlebook: Clinical Trials in Osteoporosis; Derek Pearson (Clinical Director),Colin G. Miller Book 20021st edition Springer-Verlag London 2002 Clini

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Study Design and Endpointshere has not been a clear hypothesis, endpoints are inappropriate and the study design inadequate, then it is unlikely that the outcome of the study will be used to contribute to the process of regulatory approval, or form part of a meta-analysis. It is important to get the design right from the sta

Accede

Ethical Considerations the declaration of Helsinki, Edinburgh Amendment 2000.. This has been enshrined in Good Clinical Practice (GCP) guidelines that have been produced by the International Committee for Harmonization (ICH) and adopted by the Food and Drug Administration (FDA) for the USA. and the Committee for Propriet

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Local Site Organizatione sponsor has made an assessment of the patient population and facilities available. It is now up to the investigator, site administrator and staff to prove the sponsor made the right decision in placing the study at their site. Since delays in study start-up can cause a sponsor to lose millions of