Clinical trials items required

An outline of the data from non-clinical studies must be submitted to the PMDA with the protocol for the proposed clinical study before commencing the clinical trial. A notification is required for each protocol. The list of items required for Clinical Trial Plan Notification is shown in Table 23.4. Furthermore, supplementary data must be added on entry to subsequent clinical phases, that is, general clinical trials and comparative trials. Such data are reviewed by the PMDA, and for this purpose the sponsor must wait for 30 days after submitting the initial notification before executing a contract with the medical institute. For a subsequent notification, the review period is reduced to 14 days. The notification also... 

Box 19.2 List of items required for clinical trial plan notification ... 

One particularly stark example of the importance of an end-to-end project management authority, or at least consensus on the appropriate transition point, is in the development of medical countermeasures See Box 5.1 highlighting some failures of medical products where poor transition between development stages was a contributing factor). The root of the difficulty is that development and acquisition of these items must contend with regulatory requirements— e.g., good laboratory and manufacturing processes, clinical trials, and acquisition of safety and efficacy data—and these requirements must be met in order to obtain FDA approval of the final... 

Alzheimer s Disease Assessment Scale (ADAS) Structured interview 21 items total 11 items in the cognitive (COG) subset. 10 items in the noncognitive behavioral subset. Each subset may be scored separately from the total ADAS score Takes 45 minutes to administer the ADAS and 35 minutes for the ADAS-COG. The ADAS-COG refers to the cognitive assessment subset commonly used to measure cognitive function in clinical drug trials. Requires training for administration and scoring... 

IND Content and Format. As shown in Fig. 1, item 12 of the form FDA 1571 outlines the 10 parts of the IND. This section will detail the requirements for each of those parts and provide illustrations and examples of the items to be presented in the IND. It must be emphasized again that the information to be provided in the following sections represents more complete IND data to support a clinical program in phase 2 or 3. The lesser requirements for phase 1 trials have been discussed previously. 

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