Regulatory submissions clinical trials

Phase Ilia. Trials conducted after efficacy of the medicine is demonstrated, but prior to regulatory submission of a New Drug Application (NDA) or other dossier. These clinical trials are conducted in patient populations for which the medicine is eventually intended. Phase Ilia clinical trials generate additional data... 

Phase Illb. Clinical trials conducted after regulatory submission of an NDA or other dossier, but prior to the medicine s approval and launch. These trials may supplement earher trials, complete earlier trials, or may be directed toward new types of trials (e.g., quality of life, marketing) or Phase IV evaluations. This is the period between submission and approval of a regulatory dossier for marketing authorization. 

Government bodies have on occasion accelerated clinical trials against advice from researchers, in response to public demands (Exhibit 6.15). The climate today is that due diligence regarding safety has to be performed before the drug is administered to human subjects and that clinical trial submissions have to be approved by the regulatory authorities before the trial commences. 

Most clinical trials have problems, sometimes detected by inspection and audit. These can usually be resolved and, if so, the regulatory submission must include a full explanation of how they were dealt with. Therefore, an audit trail with all the data should be available, accompanied by a statement by QA confirming that the procedures have been audited. 

The submission must be formatted in a manner that is consistent with the requirements of the regulatory agency that will review the submission. The dossier may include 20 or more individual clinical trial reports. They should be uniform in format to assist the reader to assimilate evidence readily and to compare it between trials. The whole dossier should be one of accuracy, consistency and meticulous cross-referencing. Once again, the effort to reach these objectives must be made in the early planning stages. 

The type of submission considered by DSEB to be appropriate for a PI update depends on the regulatory and clinical history of the drug in Australia and overseas, with special reference to the United Kingdom, United States, Sweden, Canada and the Netherlands. Submissions based on company sponsored clinical trials are usually required for drugs marketed for less than 5 years, whereas any of the three types of submission can be used for drugs marketed for more than 10 years. Drugs marketed between 5 and 10 years will be considered on a case by case basis, but it is generally expected that either a conventional or hybrid submission will be submitted. 

The Indian regulatory system requires submission of reproductive toxicity study data in animals in support of Phase II and Phase III clinical trials. Table I provides all preclinical data that are required for the various phases of clinical studies. 

Two types of clinical trials are typically performed by CGM manufacturers for submission to regulatory bodies to obtain approval to sell their devices. The first type of trial is generally called the accuracy trial. Clinical trial subjects are placed in a clinic or hospital for a large portion of their day. The CGM device is calibrated... 

Lack of QA oversight and guidance during these critical final steps usually results in significant disparities between the material used during clinical trials and the information contained in the regulatory submission s CMC section. 

Examples of product quality GxP data include study data (e.g., stability trial data, clinical trial data, patient and animal records/results), regulatory submissions (e.g., stability data, development summary reports), analytical production data (e.g., analytical methods, quality reference data), and compliance management (e.g., indexes to archived documents/records). 

Clinical Trial Data Collection Systems Clinical Trial Review Tools Inventory System Electronic Publishing Regulatory Submissions... 

A number of preclinical toxicology studies need to be completed and documented in a regulatory agency submission before initiating human clinical trials. The number and types of toxicology studies depend on... 

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