Clinical trials investigator choice

Choice of Control Group and Related Issues in Clinical Trials Clinical Investigation of Medicinal Products in the Pediatric Population... 

The mechanism of regulatory control is dependent upon whether the clinical trial is conducted under the auspices of a company, or independently, for example, by a medical or dented practitioner and whether it is to be conducted within or outside the terms (e.g., indication, dosage) of an MA. Most commonly the clinical trial will be sponsored by a company, and be designed to investigate a new aspect of efficacy or Scifety in the absence of or outside the terms of an MA in this case the company sponsor must, by application to the MCA, obtain a Clinical Trial Exemption (CTX), or rarely by choice, a Cliniced Trial Certificate (CTC). However,... 

Although discussed in detail elsewhere in this book, the two ethical principles guiding informed consent are those of autonomy and equipoise. Autonomy is the concept that the patient is an individual that is under no duress, whether subtle or obvious, actual or inferred, and is competent to make a choice according to his or her free will. Clinical trials conducted on persons in custody, or on subordinate soldiers, may both be violations of the patient s autonomy. Equipoise is the concept that the investigator, and those sponsoring the trial, are truly uncertain as to the outcome of the study in practical terms, this is a guarantee to the patient that an unreasonable hazard cannot result from unfavorable randomization because the treatment options are not known to be unequally hazardous. 

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