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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
Laboratory
  1. On what basis we can choose a central laboratory? What all to be considered in selecting it?
    Although there is no regulatory requirement for central laboratory, the requirements of ICH GCP (data quality, documentation of procedures and document control) mean that central laboratory facilities are useful as part of integrated clinical trial procedures. The criteria for selecting central laboratory are: Adherence to Good Laboratory Practice (GLP), Accreditation by a reputed international organisation eg. College of American Pathologists (CAP), Quality assurance, Staff training, Efficiency of processing samples Speed of services, Networking and transport of samples, Past track record/ experience in a clinical trial.
  2. Are there any lists of laboratory tests, which are to be performed in pre-study investigations for the volunteers? What are the criteria for inclusion of particular tests in pre-study/ post-study laboratory investigations?
    US FDA guidance for the industry, ‘‘General Considerations for the clinical evaluation of drugs’’ suggests the following investigations for phase I volunteers: CBC including platelet, urinalysis, BUN or creatinine, liver function, FBS or 2 hour postprandial sugar, ECG. Any other investigations as per the profile of the drug under investigation.
  		 


Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
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