1.Sharing Clinical Trial Data: A Proposal from the International Committee of Medical Journal Editors.
Darren B TAICHMAN ; Joyce BACKUS ; Christopher BAETHGE ; Howard BAUCHNER ; Peter W de LEEUW ; Jeffrey M DRAZEN ; John FLETCHER ; Frank FRIZELLE ; Trish GROVES ; Abraham HAILEAMLAK ; Astrid JAMES ; Christine LAINE ; Larry PEIPERL ; Anja PINBORG ; Peush SAHNI ; Si-Nan WU
Chinese Medical Journal 2016;129(2):127-128
2.Are You "Tilting at Windmills" or Undertaking a Valid Clinical Trial?.
John D STEEVES ; Jose ZARIFFA ; John L K KRAMER
Yonsei Medical Journal 2011;52(5):701-716
In this review, several aspects surrounding the choice of a therapeutic intervention and the conduct of clinical trials are discussed. Some of the background for why human studies have evolved to their current state is also included. Specifically, the following questions have been addressed: 1) What criteria should be used to determine whether a scientific discovery or invention is worthy of translation to human application? 2) What recent scientific advance warrants a deeper understanding of clinical trials by everyone? 3) What are the different types and phases of a clinical trial? 4) What characteristics of a human disorder should be noted, tracked, or stratified for a clinical trial and what inclusion /exclusion criteria are important to enrolling appropriate trial subjects? 5) What are the different study designs that can be used in a clinical trial program? 6) What confounding factors can alter the accurate interpretation of clinical trial outcomes? 7) What are the success rates of clinical trials and what can we learn from previous clinical trials? 8) What are the essential principles for the conduct of valid clinical trials?
Animals
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Clinical Protocols
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Clinical Trials as Topic/ethics/*methods
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Disease Models, Animal
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Female
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Humans
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Male
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Outcome Assessment (Health Care)
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Pregnancy
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Translational Medical Research
3.Exploration of the placebo control issue in clinical trials of anti-cancer drugs.
Chinese Journal of Oncology 2009;31(5):398-400
Antineoplastic Agents
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administration & dosage
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therapeutic use
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Case-Control Studies
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Controlled Clinical Trials as Topic
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methods
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Ethics, Medical
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Helsinki Declaration
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Humans
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Neoplasms
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drug therapy
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Placebos
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Randomized Controlled Trials as Topic
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methods
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Therapeutic Equivalency