Clinical Protocols concomitant medications

The inclusion and exclusion criteria are described in the Subject Selection part of the protocol. To a large extent, the success or failure of a particular clinical trial can often be traced back to how well these criteria were developed. Good protocol authors strive to include the most appropriate patient population to satisfy the study objective and still include those kinds of patients who will ultimately receive the drug. Therefore, selection criteria can be unreasonable and unnecessary in some cases and vague and not specific in other cases. The management of concomitant medications is particularly problematic. The protocol must attempt to define those medications that are permitted for intercurrent illnesses and those that are prohibited as they will interfere with the interpretation of the test medication. Although there are no easy answers, quality protocols are able to justify with some precision the rationale for each inclusion and criteria. How these criteria are applied is handled in the Screening for Study Entry section. 

All research personnel must search for clues about safety events from many sources, such as information in clinical records at the study sites information in data collection forms (e.g. CRFs, diary cards, quality-of-life forms, psychiatric rating scales, etc.), occurrence of missed and/or unscheduled visits, dropouts and withdrawals use of any concomitant medications/devices and abnormal laboratory data. AEs may also occur simply as a result of study procedures and study participation. Information about definitions of AEs and requirements for reporting AEs must be clearly stated in the protocol and explained to the site staff, who must also be educated in the correct procedure and immediate requirement for reporting any AE suspected to be serious or unexpected as per the regulatory definitions. 

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