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In pharmaceutical/clinical development of a test drug or treatment, relevant clinical data are usually collected from subjects with the diseases under study in order to evaluate the safety and efficacy of the test drug or treatment under investigation. It is necessary to conduct well-controlled clinical trials under a valid study design to provide an accurate and reliable assessment. A clinical trial process is a lengthy and costly process but is nevertheless necessary to ensure a fair and reliable assessment of the test treatment under investigation. It consists of protocol development, trial conduct, data collection, statistical analysis/interpretation, and reporting. In practice, controversial issues inevitably occur regardless of the compliance with good statistical practice (GSP) and good clinical practice (GCP). Controversial issues are basically debatable issues that are commonly encountered during the conduct of clinical trials. In practice, these issues could be raised from, but are not limited to, (1) compromises between theoretical and real/common practices; (2) miscommunication and/or misunderstanding in perception/interpretation among regulatory agencies, clinical scientists, and biostatisticians; and (3) disagreement, inconsistency, miscommunication/misunderstanding, and errors in clinical practice.
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